Trial | Outcome |
NCT00016718 (3) [back to overview] | Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment. |
NCT00016718 (3) [back to overview] | Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16 |
NCT00016718 (3) [back to overview] | Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16 |
NCT00042289 (26) [back to overview] | Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms |
NCT00042289 (26) [back to overview] | Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs |
NCT00042289 (26) [back to overview] | Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs |
NCT00042289 (26) [back to overview] | Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (95% CI) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in ng/mL With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C12) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C12) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C24) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Trough Concentration (C24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Area Under the Curve From 0 to 24 Hours (AUC24) With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Maximum Concentration (Cmax) in mg/L With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms |
NCT00042289 (26) [back to overview] | Plasma Concentration for Contraceptives |
NCT00042289 (26) [back to overview] | PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (Range) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | PK Parameter: Cord/Maternal Blood Concentration Ratio With Median (IQR) for ARVs and TB Drugs |
NCT00042289 (26) [back to overview] | Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs |
NCT00074581 (2) [back to overview] | Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms |
NCT00074581 (2) [back to overview] | All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms |
NCT00084136 (18) [back to overview] | Time to Immunologic Failure (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Immunologic Failure (PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Treatment Failure (PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Treatment Failure (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison) |
NCT00084136 (18) [back to overview] | Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison) |
NCT00084136 (18) [back to overview] | Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison) |
NCT00084136 (18) [back to overview] | Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison) |
NCT00084136 (18) [back to overview] | Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison) |
NCT00089505 (9) [back to overview] | Percent of Participants Who Experienced Virologic Failure or Died |
NCT00089505 (9) [back to overview] | Number of Participants Who Experienced HIV-related Disease Progression or Death |
NCT00089505 (9) [back to overview] | Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen. |
NCT00089505 (9) [back to overview] | Number of Participants Who Experienced Virologic Failure or Died. |
NCT00089505 (9) [back to overview] | Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality |
NCT00089505 (9) [back to overview] | CD4 Count Change From Randomization |
NCT00089505 (9) [back to overview] | Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month |
NCT00089505 (9) [back to overview] | Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry |
NCT00089505 (9) [back to overview] | Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry |
NCT00090779 (9) [back to overview] | Time to Treatment Initiation or Death |
NCT00090779 (9) [back to overview] | Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation |
NCT00090779 (9) [back to overview] | Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm |
NCT00090779 (9) [back to overview] | Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm |
NCT00090779 (9) [back to overview] | Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm |
NCT00090779 (9) [back to overview] | Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation |
NCT00090779 (9) [back to overview] | Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation |
NCT00090779 (9) [back to overview] | Number of Participants in IT Arm Off Treatment Before 36 Weeks |
NCT00090779 (9) [back to overview] | Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%. |
NCT00099632 (5) [back to overview] | Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping |
NCT00099632 (5) [back to overview] | Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping. |
NCT00099632 (5) [back to overview] | Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping. |
NCT00099632 (5) [back to overview] | Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12 |
NCT00099632 (5) [back to overview] | Number of Participants Who Discontinued Study Treatment Prematurely |
NCT00105079 (6) [back to overview] | Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters |
NCT00105079 (6) [back to overview] | Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count |
NCT00105079 (6) [back to overview] | Change From Baseline in HIV-1 RNA Viral Load |
NCT00105079 (6) [back to overview] | Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL |
NCT00105079 (6) [back to overview] | Number of Participants Assessed for Adverse Events (AEs) |
NCT00105079 (6) [back to overview] | Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48. |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline. |
NCT00112047 (53) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Change in Limb Fat (kg) From Week 48 to Week 144 |
NCT00112047 (53) [back to overview] | Change in Limb Fat (kg) From Week 48 to Week 96 |
NCT00112047 (53) [back to overview] | Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Change in Total Body Fat (kg) From Week 48 to Week 144 |
NCT00112047 (53) [back to overview] | Change in Total Body Fat (kg) From Week 48 to Week 96 |
NCT00112047 (53) [back to overview] | Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Change in Trunk Fat (kg) From Week 48 to Week 144 |
NCT00112047 (53) [back to overview] | Change in Trunk Fat (kg) From Week 48 to Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm) |
NCT00112047 (53) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96) |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48 |
NCT00112047 (53) [back to overview] | Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96 |
NCT00118898 (22) [back to overview] | Number of Participants With Treatment Modification |
NCT00118898 (22) [back to overview] | Number of Participants With Regimen Failure |
NCT00118898 (22) [back to overview] | Amount of Study Follow-up |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing Treatment Modification |
NCT00118898 (22) [back to overview] | Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) |
NCT00118898 (22) [back to overview] | Time From Treatment Dispensation to a Grade 3/4 Safety Event |
NCT00118898 (22) [back to overview] | Time From Randomization to Virologic Failure |
NCT00118898 (22) [back to overview] | Time From Treatment Dispensation to Treatment Modification |
NCT00118898 (22) [back to overview] | The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL |
NCT00118898 (22) [back to overview] | Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event |
NCT00118898 (22) [back to overview] | Change in Fasting Triglyceride Level From Baseline |
NCT00118898 (22) [back to overview] | Change in Fasting Total Cholesterol Level From Baseline |
NCT00118898 (22) [back to overview] | Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline |
NCT00118898 (22) [back to overview] | Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline |
NCT00118898 (22) [back to overview] | Number of Participants With a Grade 3/4 Safety Event |
NCT00118898 (22) [back to overview] | Change in CD4 Count (Cells/mm3) From Baseline |
NCT00118898 (22) [back to overview] | Number of Participants With Virologic Failure and Emergence of Major Resistance |
NCT00118898 (22) [back to overview] | Number of Participants With Virologic Failure |
NCT00118898 (22) [back to overview] | Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events. |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing Virologic Failure |
NCT00118898 (22) [back to overview] | Cumulative Probability of Not Experiencing Regimen Failure |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis. |
NCT00244712 (14) [back to overview] | Median Change From Baseline in CD4+ Cells at Weeks 48 and 96 |
NCT00244712 (14) [back to overview] | Median Change From Baseline in HIV-1 RNA at Week 48 and 96 |
NCT00244712 (14) [back to overview] | Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility |
NCT00244712 (14) [back to overview] | Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks |
NCT00244712 (14) [back to overview] | Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96 |
NCT00244712 (14) [back to overview] | Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 |
NCT00244712 (14) [back to overview] | Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL) |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL) |
NCT00272779 (88) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 |
NCT00272779 (88) [back to overview] | Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 |
NCT00272779 (88) [back to overview] | Reduction of log10 HIV RNA Levels From Baseline to Week 48 |
NCT00272779 (88) [back to overview] | Reduction of log10 HIV RNA Levels From Baseline at Week 96 |
NCT00272779 (88) [back to overview] | Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4 |
NCT00272779 (88) [back to overview] | Percentage of Participants With Lipoatrophy at Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With HIV RNA < 50 c/mL) at Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With HIV RNA < 400 c/mL) at Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With HIV RNA < 400 c/mL at Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm) |
NCT00272779 (88) [back to overview] | Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48 |
NCT00272779 (88) [back to overview] | Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 |
NCT00272779 (88) [back to overview] | Mean Changes in Fasting Insulin at Week 96 |
NCT00272779 (88) [back to overview] | Mean Changes in Fasting Glucose at Week 96 |
NCT00272779 (88) [back to overview] | Mean Changes From Baseline in Body Weight at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change in Weight From Baseline at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change in Fasting Insulin at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change in Fasting Glucose at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change in Body Mass Index (BMI) in Participants at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Waist-to-hip-ratio at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Waist-to-hip-ratio at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Waist Circumference at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Waist Circumference at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in CD4 Cell Count at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Body Weight at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Body Weight at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in BMI at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in BMI at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in BMI at Week 48 |
NCT00272779 (88) [back to overview] | Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4 |
NCT00272779 (88) [back to overview] | Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4 |
NCT00272779 (88) [back to overview] | Cmin of Tenofovir at Week 4 |
NCT00272779 (88) [back to overview] | Cmin of RTV at Week 4 |
NCT00272779 (88) [back to overview] | Cmax of Tenofovir at Week 4 |
NCT00272779 (88) [back to overview] | Cmax of RTV at Week 4 |
NCT00272779 (88) [back to overview] | AUC (TAU) of Tenofovir at Week 4 |
NCT00272779 (88) [back to overview] | AUC (0-24) of RTV at Week 4 |
NCT00272779 (88) [back to overview] | Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL) |
NCT00272779 (88) [back to overview] | Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC) |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48 |
NCT00272779 (88) [back to overview] | Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96 |
NCT00272779 (88) [back to overview] | Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48 |
NCT00272779 (88) [back to overview] | Median Changes From Baseline at Week 96 in VAT-to-TAT, VAT-to-SAT and, Trunk-to-limb Fat Ratio Measured by Computed Tomography (CT)/DEXA |
NCT00272779 (88) [back to overview] | Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96 |
NCT00272779 (88) [back to overview] | Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48 |
NCT00272779 (88) [back to overview] | Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48 |
NCT00272779 (88) [back to overview] | Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96 |
NCT00272779 (88) [back to overview] | Mean Changes in Fasting Lipids at Week 96 |
NCT00272779 (88) [back to overview] | Mean Change in Fasting Lipid at Week 48 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in VAT Associated With RETN_730 |
NCT00272779 (88) [back to overview] | Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144 |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144 |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144 |
NCT00298363 (38) [back to overview] | Median Change in MELD Score From Baseline at Week 144 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks |
NCT00298363 (38) [back to overview] | Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48 |
NCT00298363 (38) [back to overview] | In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48 |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144 |
NCT00298363 (38) [back to overview] | Percent Probability of Tolerability Failure |
NCT00298363 (38) [back to overview] | Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL |
NCT00298363 (38) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96 |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline) |
NCT00298363 (38) [back to overview] | Median Time-averaged Change (DAVG) in Plasma Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels at 48 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Median DAVG in Plasma HBV DNA Levels at 96 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Median DAVG in Plasma HBV DNA Levels at 168 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Median DAVG in Plasma HBV DNA Levels at 144 Weeks Relative to Baseline |
NCT00298363 (38) [back to overview] | Median Change in Model for End-Stage Liver Disease (MELD) Score From Baseline at Week 48 |
NCT00298363 (38) [back to overview] | Median Change in MELD Score From Baseline at Week 96 |
NCT00298363 (38) [back to overview] | Median Change in MELD Score From Baseline at Week 168 |
NCT00298363 (38) [back to overview] | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48 |
NCT00307489 (19) [back to overview] | Hepatitis B Early Antigen (HBeAg) Loss at Week 168 |
NCT00307489 (19) [back to overview] | Change From Baseline in log10 Plasma HBV DNA Levels at Week 168 |
NCT00307489 (19) [back to overview] | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168 |
NCT00307489 (19) [back to overview] | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48 |
NCT00307489 (19) [back to overview] | HBsAg Loss at Week 168 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normalized ALT at Week 48 |
NCT00307489 (19) [back to overview] | HBeAg Seroconversion at Week 48 |
NCT00307489 (19) [back to overview] | Change From Baseline in log10 Plasma HBV DNA Levels at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168 |
NCT00307489 (19) [back to overview] | HBsAg Loss at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normalized ALT at Week 168 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normal ALT at Week 48 |
NCT00307489 (19) [back to overview] | Percentage of Participants With Normal ALT at Week 168 |
NCT00307489 (19) [back to overview] | Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48 |
NCT00307489 (19) [back to overview] | Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168 |
NCT00307489 (19) [back to overview] | Hepatitis B Early Antigen (HBeAg) Loss at Week 48 |
NCT00335322 (2) [back to overview] | Time Weighted Mean Change From Baseline Plasma HIV-RNA |
NCT00335322 (2) [back to overview] | Time-weighted Mean Change From Baseline Plasma HIV-RNA. |
NCT00357552 (11) [back to overview] | Number of Participants With Study-targeted Diagnoses and Clinical Events |
NCT00357552 (11) [back to overview] | Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study. |
NCT00357552 (11) [back to overview] | Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure. |
NCT00357552 (11) [back to overview] | Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma |
NCT00357552 (11) [back to overview] | Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening. |
NCT00357552 (11) [back to overview] | Percentage of Subjects Reporting Not Skipping Medications in the Last Month. |
NCT00357552 (11) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104 |
NCT00357552 (11) [back to overview] | Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy |
NCT00357552 (11) [back to overview] | Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure. |
NCT00357552 (11) [back to overview] | Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification |
NCT00357552 (11) [back to overview] | Change in CD4+ Cell Counts From Study Entry to Week 104 |
NCT00364793 (28) [back to overview] | Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants |
NCT00364793 (28) [back to overview] | Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants |
NCT00364793 (28) [back to overview] | The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants |
NCT00364793 (28) [back to overview] | The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants |
NCT00364793 (28) [back to overview] | The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants |
NCT00364793 (28) [back to overview] | The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants |
NCT00364793 (28) [back to overview] | Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants |
NCT00364793 (28) [back to overview] | Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants |
NCT00364793 (28) [back to overview] | Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population |
NCT00364793 (28) [back to overview] | Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound |
NCT00364793 (28) [back to overview] | Number of Participants With Serum Chemistry Abnormalities - Treated Participants |
NCT00364793 (28) [back to overview] | Number of Participants With On-Treatment Adverse Events (AEs), Related Adverse Events, Serious Adverse Events (SAEs), Death, Discontinuation Due to Adverse Events, and CDC Class C AIDS Events |
NCT00364793 (28) [back to overview] | Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population |
NCT00364793 (28) [back to overview] | CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants |
NCT00364793 (28) [back to overview] | Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants |
NCT00364793 (28) [back to overview] | Number of Participants With Hematologic Abnormalities - Treated Participants |
NCT00364793 (28) [back to overview] | Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population |
NCT00364793 (28) [back to overview] | The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants |
NCT00364793 (28) [back to overview] | Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants |
NCT00364793 (28) [back to overview] | The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants |
NCT00369941 (73) [back to overview] | Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Drug-related LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156 |
NCT00369941 (73) [back to overview] | Change From Baseline in CD4 Cell Count at Week 156 |
NCT00369941 (73) [back to overview] | Change From Baseline in CD4 Cell Count at Week 240 |
NCT00369941 (73) [back to overview] | Change From Baseline in CD4 Cell Count at Week 96 |
NCT00369941 (73) [back to overview] | Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With Drug-related LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With Serious Drug-related LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants Discontinued With LAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Died by Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48 |
NCT00369941 (73) [back to overview] | Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96 |
NCT00369941 (73) [back to overview] | Number of Participants With CAEs at Week 156 |
NCT00369941 (73) [back to overview] | Number of Participants With CAEs at Week 240 |
NCT00369941 (73) [back to overview] | Number of Participants With CAEs at Week 96 |
NCT00414518 (3) [back to overview] | Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome |
NCT00414518 (3) [back to overview] | Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms |
NCT00414518 (3) [back to overview] | Viral Set Point |
NCT00442962 (11) [back to overview] | Time to First Safety Event |
NCT00442962 (11) [back to overview] | Late Change in CD4 Count From Baseline |
NCT00442962 (11) [back to overview] | Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm) |
NCT00442962 (11) [back to overview] | Percentage of Participants With Early Virologic Suppression |
NCT00442962 (11) [back to overview] | Percentage of Participants With Early Virologic Response |
NCT00442962 (11) [back to overview] | Time to Initial Virological Failure |
NCT00442962 (11) [back to overview] | Time to Initial Virologic Response |
NCT00442962 (11) [back to overview] | Time to First Dose Modification |
NCT00442962 (11) [back to overview] | Early Changes in CD4 Count From Baseline |
NCT00442962 (11) [back to overview] | Percentage of Participants With Late Virologic Suppression |
NCT00442962 (11) [back to overview] | Percentage of Participants With Late Virologic Response |
NCT00448669 (6) [back to overview] | Antiretroviral (ARV) Resistance Patterns in Seroconverters |
NCT00448669 (6) [back to overview] | CD4 Evaluation After HIV Seroconversion |
NCT00448669 (6) [back to overview] | HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms |
NCT00448669 (6) [back to overview] | Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms |
NCT00448669 (6) [back to overview] | Rates of Adherence to Study Medication |
NCT00448669 (6) [back to overview] | Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts |
NCT00524173 (4) [back to overview] | Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48 |
NCT00524173 (4) [back to overview] | Number of Participants With HBV DNA <1000 IU/ml at Week 192 |
NCT00524173 (4) [back to overview] | Number of Participants With Loss of HBsAg |
NCT00524173 (4) [back to overview] | Number of Participants With Normalized Alanine Aminotransferase (ALT) |
NCT00549198 (58) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96 |
NCT00549198 (58) [back to overview] | "Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized" |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48 |
NCT00549198 (58) [back to overview] | Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96 |
NCT00549198 (58) [back to overview] | Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96 |
NCT00549198 (58) [back to overview] | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96 |
NCT00549198 (58) [back to overview] | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48 |
NCT00549198 (58) [back to overview] | Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24 |
NCT00549198 (58) [back to overview] | Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24 |
NCT00549198 (58) [back to overview] | Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96 |
NCT00549198 (58) [back to overview] | Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96 |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment |
NCT00552240 (46) [back to overview] | Incidence of Patients With AIDS Progression at Each Visit |
NCT00552240 (46) [back to overview] | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml |
NCT00552240 (46) [back to overview] | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants |
NCT00552240 (46) [back to overview] | Proportion of Patients Reporting Rash of Any Severity |
NCT00552240 (46) [back to overview] | Proportion of Patients Reporting Hepatic Events of Any Severity |
NCT00552240 (46) [back to overview] | Proportion of Patients Reporting CNS Side Effects of Any Severity |
NCT00552240 (46) [back to overview] | Percentage Adherence by Pill Count |
NCT00552240 (46) [back to overview] | Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48 |
NCT00552240 (46) [back to overview] | Change in Framingham Score |
NCT00552240 (46) [back to overview] | Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio |
NCT00552240 (46) [back to overview] | Change in Fasting Plasma Triglycerides Level |
NCT00552240 (46) [back to overview] | Change in Fasting Plasma Total Cholesterol Level |
NCT00552240 (46) [back to overview] | Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level |
NCT00552240 (46) [back to overview] | Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 8. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 6. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 48. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 4. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 36. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 24. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 2. |
NCT00552240 (46) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 12. |
NCT00552240 (46) [back to overview] | AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death |
NCT00552240 (46) [back to overview] | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response |
NCT00552240 (46) [back to overview] | Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities |
NCT00552240 (46) [back to overview] | Number of Patients With Virologic Rebound to >400 Copies/ml |
NCT00552240 (46) [back to overview] | Number of Participants With Virologic Success (FDA Definition) |
NCT00552240 (46) [back to overview] | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00552240 (46) [back to overview] | Number of Participants With Virologic Response (VR) |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment |
NCT00552240 (46) [back to overview] | Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment |
NCT00557245 (11) [back to overview] | Head Circumference Among Infants Born to Female Participants Taking Study Drug |
NCT00557245 (11) [back to overview] | Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC |
NCT00557245 (11) [back to overview] | Weight Among Infants Born to Female Participants Taking Study Drug |
NCT00557245 (11) [back to overview] | Study Drug Adherence: Self-reported Missed Doses of Study Drug |
NCT00557245 (11) [back to overview] | Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants |
NCT00557245 (11) [back to overview] | Length Among Infants Born to Female Participants Taking Study Drug |
NCT00557245 (11) [back to overview] | Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses. |
NCT00557245 (11) [back to overview] | Prevalence of Unprotected Sex During Follow-up |
NCT00557245 (11) [back to overview] | Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up |
NCT00557245 (11) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
NCT00557245 (11) [back to overview] | Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug. |
NCT00594646 (2) [back to overview] | Number of HIV-1 Infected Participants |
NCT00594646 (2) [back to overview] | Medication Regimen Completion Rates |
NCT00608569 (8) [back to overview] | Confirmed Virologic Failure at or Prior to Week 48 |
NCT00608569 (8) [back to overview] | Confirmed Virologic Failure at or Prior to Week 24 |
NCT00608569 (8) [back to overview] | CD8 Count at Follow-up Visits |
NCT00608569 (8) [back to overview] | Time to First Grade 3 or 4 Sign or Symptom |
NCT00608569 (8) [back to overview] | Time to First Grade 3 or 4 Lab or Sign/Symptom Event |
NCT00608569 (8) [back to overview] | CD4 Count at Follow-up Visits |
NCT00608569 (8) [back to overview] | Adherence to Second Line HAART Regimen |
NCT00608569 (8) [back to overview] | Time to First Grade 3 or 4 Lab Event |
NCT00625404 (12) [back to overview] | Confirmed Grade 3 or Higher ALT Elevation |
NCT00625404 (12) [back to overview] | FTC and/or Tenofovir Resistance |
NCT00625404 (12) [back to overview] | HIV Infection |
NCT00625404 (12) [back to overview] | Participant Report of Change in Number of Sexual Partners |
NCT00625404 (12) [back to overview] | Pill Counts and Participant Report of Adherence to Once-daily Pill Taking |
NCT00625404 (12) [back to overview] | Plasma HIV RNA Level (HIV-1 Viral Load) |
NCT00625404 (12) [back to overview] | Pregnancy Complications |
NCT00625404 (12) [back to overview] | Confirmed Grade 3 or Higher Reduction in Phosphorus |
NCT00625404 (12) [back to overview] | Confirmed Grade 3 or Higher AST Elevation |
NCT00625404 (12) [back to overview] | Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration |
NCT00625404 (12) [back to overview] | CD4+ T-cell Count |
NCT00625404 (12) [back to overview] | Confirmed Grade 2 or Higher Serum Creatinine Toxicity |
NCT00632970 (1) [back to overview] | Absolute Change in CD4 Cell Counts |
NCT00641641 (1) [back to overview] | Mean Change From Baseline Plasma HIV RNA (Log Copies/mL) |
NCT00654147 (6) [back to overview] | Study Medication Toxicity-related Discontinuation . |
NCT00654147 (6) [back to overview] | Time to Confirmed Virologic Failure |
NCT00654147 (6) [back to overview] | Time to Virologic Failure |
NCT00654147 (6) [back to overview] | Change From Baseline CD4+ and CD8+ Cell Counts |
NCT00654147 (6) [back to overview] | Weeks to HIV-1 RNA <200 Copies/ml |
NCT00654147 (6) [back to overview] | Study Medication Tolerability |
NCT00662545 (5) [back to overview] | HIV RNA < 75 Copies/ml |
NCT00662545 (5) [back to overview] | Hepatitis B Virus (HBV) DNA |
NCT00662545 (5) [back to overview] | Incidence of Permanent Discontinuation Due to Toxicity |
NCT00662545 (5) [back to overview] | Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy) |
NCT00662545 (5) [back to overview] | Incidence of ALT Flares |
NCT00705679 (11) [back to overview] | Person-years of Follow-up of Oral TDF and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms |
NCT00705679 (11) [back to overview] | Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms |
NCT00705679 (11) [back to overview] | Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product |
NCT00705679 (11) [back to overview] | Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms |
NCT00705679 (11) [back to overview] | Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms |
NCT00705679 (11) [back to overview] | Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lactate (Millimoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Temperature (°F) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter) |
NCT00711009 (82) [back to overview] | Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication |
NCT00711009 (82) [back to overview] | Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication |
NCT00711009 (82) [back to overview] | Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM) |
NCT00711009 (82) [back to overview] | Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00711009 (82) [back to overview] | Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sodium (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Potassium (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Platelet Count (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Neutrophils (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Monocytes (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Mid-Thigh Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Mid-Arm Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lymphocytes (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lipase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Leptin (Nanograms/Milliliter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Interleukin-6 (Nanograms/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Insulin (Picomoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Hips Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Hemoglobin (Grams/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Hematocrit (Fraction) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Fasting Glucose (Millimoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Eosinophils (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Creatinine (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Creatine Phosphokinase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Cholesterol (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Chloride (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Chest Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Calcium (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Bicarbonate (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Basophils (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Alkaline Phosphatase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Albumin (Grams/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Alanine Aminotransferase (Units/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Adiponectin (Micrograms/Milliliter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter) |
NCT00711009 (82) [back to overview] | Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Weight (kg) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Waist Measurement (cm) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Magnesium (Millimoles/Liter) |
NCT00711009 (82) [back to overview] | Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey |
NCT00711009 (82) [back to overview] | Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values |
NCT00711009 (82) [back to overview] | Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events |
NCT00711009 (82) [back to overview] | Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00711009 (82) [back to overview] | Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel. |
NCT00711009 (82) [back to overview] | Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit |
NCT00711009 (82) [back to overview] | Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672 |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Urine Specific Gravity |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Urine pH |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Uric Acid (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Triglycerides (Micromoles/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Total Protein (Grams/Liter) |
NCT00711009 (82) [back to overview] | Mean Change From Baseline in Total Bilirubin (Micromoles/Liter) |
NCT00724711 (14) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline C-Reactive Protein at Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT00724711 (14) [back to overview] | Change From Baseline Fasting Glucose at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Fibrinogen at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Fasting Lipid Parameters at Week 48 |
NCT00724711 (14) [back to overview] | Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48 |
NCT00724711 (14) [back to overview] | Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48 |
NCT00743340 (1) [back to overview] | Number of Participants Who Had Access to, and Received the Intervention |
NCT00752856 (4) [back to overview] | Viral Suppression Efficacy at 48 Weeks |
NCT00752856 (4) [back to overview] | To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations. |
NCT00752856 (4) [back to overview] | Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48 |
NCT00752856 (4) [back to overview] | Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4. |
NCT00757783 (16) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF). |
NCT00757783 (16) [back to overview] | Change From Baseline in Insulin at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA. |
NCT00757783 (16) [back to overview] | Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F) |
NCT00757783 (16) [back to overview] | Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48 |
NCT00757783 (16) [back to overview] | Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Glucose at Week 12 and 48. |
NCT00757783 (16) [back to overview] | Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12 |
NCT00757783 (16) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF). |
NCT00757783 (16) [back to overview] | Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values. |
NCT00762892 (5) [back to overview] | Change From Baseline in Log HIV Viral Load at 48 Weeks |
NCT00762892 (5) [back to overview] | Change From Baseline in Lipids at 48 Weeks |
NCT00762892 (5) [back to overview] | Change From Baseline in Homocysteine at 6 Months |
NCT00762892 (5) [back to overview] | Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks |
NCT00762892 (5) [back to overview] | Change From Baseline in CD4 Count at 48 Weeks |
NCT00768989 (28) [back to overview] | Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96 |
NCT00768989 (28) [back to overview] | Raltegravir AUC (0-12h) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count |
NCT00768989 (28) [back to overview] | Baseline and Mean Change From Baseline in Total Cholesterol Levels |
NCT00768989 (28) [back to overview] | Raltegravir Tmax |
NCT00768989 (28) [back to overview] | Raltegravir Terminal Elimination Half Life |
NCT00768989 (28) [back to overview] | Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued) |
NCT00768989 (28) [back to overview] | Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4 |
NCT00768989 (28) [back to overview] | Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants |
NCT00768989 (28) [back to overview] | Raltegravir Cmin Prior to the Morning Dose |
NCT00768989 (28) [back to overview] | Raltegravir Cmin 12 Hours Postdose |
NCT00768989 (28) [back to overview] | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation |
NCT00768989 (28) [back to overview] | Mean Change From Baseline in Total Bilirubin Level |
NCT00768989 (28) [back to overview] | Mean Change From Baseline in Electrocardiogram Findings |
NCT00768989 (28) [back to overview] | Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 |
NCT00768989 (28) [back to overview] | Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Atazanavir Cmin Prior to the Morning Dose |
NCT00768989 (28) [back to overview] | Atazanavir Individual Inhibitory Quotient (IQ) |
NCT00768989 (28) [back to overview] | Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Atazanavir Terminal Elimination Half Life |
NCT00768989 (28) [back to overview] | Atazanavir Time of Maximum Observed Plasma Concentration (Tmax) |
NCT00768989 (28) [back to overview] | Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose |
NCT00768989 (28) [back to overview] | Number of Nonresponders at Week 8 |
NCT00768989 (28) [back to overview] | Raltegravir Cmax in 1 Dosing Interval |
NCT00768989 (28) [back to overview] | Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48 |
NCT00768989 (28) [back to overview] | Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24 |
NCT00768989 (28) [back to overview] | Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24 |
NCT00811954 (19) [back to overview] | Change in Fasting HDL Cholesterol Level From Baseline |
NCT00811954 (19) [back to overview] | CD4+ T-cell Count Changes From Baseline |
NCT00811954 (19) [back to overview] | Incidence of Death or AIDS Defining Events (CDC Category C) |
NCT00811954 (19) [back to overview] | CD4+ T-cell Count |
NCT00811954 (19) [back to overview] | Change in Fasting Plasma Glucose Level From Baseline |
NCT00811954 (19) [back to overview] | Change in Fasting Total Cholesterol Level From Baseline |
NCT00811954 (19) [back to overview] | Change in Fasting Triglycerides Level From Baseline |
NCT00811954 (19) [back to overview] | Change in Framingham 10-year Risk of MI or Coronary Death From Baseline |
NCT00811954 (19) [back to overview] | Change in Waist Circumference From Baseline |
NCT00811954 (19) [back to overview] | Change in Waist:Height Ratio From Baseline |
NCT00811954 (19) [back to overview] | Self-reported Adherence |
NCT00811954 (19) [back to overview] | Presence of Mutations Associated With NRTI Resistance |
NCT00811954 (19) [back to overview] | Presence of Mutations Associated With INI Resistance |
NCT00811954 (19) [back to overview] | Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance |
NCT00811954 (19) [back to overview] | Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD) |
NCT00811954 (19) [back to overview] | Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96 |
NCT00811954 (19) [back to overview] | Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96 |
NCT00811954 (19) [back to overview] | Cumulative Incidence of First Adverse Event by Week 96 |
NCT00811954 (19) [back to overview] | Cumulative Probability of First Virologic Failure by Week 96 |
NCT00827112 (16) [back to overview] | Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA |
NCT00827112 (16) [back to overview] | Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96 |
NCT00827112 (16) [back to overview] | Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14 |
NCT00827112 (16) [back to overview] | Average Observed Plasma Concentration (Cavg) of Maraviroc |
NCT00827112 (16) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Maraviroc |
NCT00827112 (16) [back to overview] | HIV-1 RNA Levels at Baseline |
NCT00827112 (16) [back to overview] | Time-Averaged Difference (TAD) in log10 Viral Load |
NCT00827112 (16) [back to overview] | Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA |
NCT00827112 (16) [back to overview] | Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay |
NCT00827112 (16) [back to overview] | Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96 |
NCT00827112 (16) [back to overview] | Time to Loss of Virological Response (TLOVR) |
NCT00827112 (16) [back to overview] | Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL) |
NCT00827112 (16) [back to overview] | Number of Participants With Phenotypic Resistance |
NCT00827112 (16) [back to overview] | Number of Participants With Genotypic Resistance |
NCT00827112 (16) [back to overview] | Minimum Observed Plasma Concentration (Cmin) of Maraviroc |
NCT00827112 (16) [back to overview] | Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Annual Rate of Change in Right Common Carotid Artery Intima-media Thickness (CIMT) |
NCT00851799 (27) [back to overview] | Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24 |
NCT00851799 (27) [back to overview] | Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Lean Mass From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Total Limb Fat From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Trunk Fat From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96 |
NCT00851799 (27) [back to overview] | CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144 |
NCT00851799 (27) [back to overview] | Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48 |
NCT00851799 (27) [back to overview] | Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48 |
NCT00851799 (27) [back to overview] | Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144 |
NCT00851799 (27) [back to overview] | Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in D-dimer From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96 |
NCT00851799 (27) [back to overview] | Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96 |
NCT00856323 (4) [back to overview] | Self-reported Methamphetamine Use in Previous 30 Days. |
NCT00856323 (4) [back to overview] | Description of Incident STI Infections. |
NCT00856323 (4) [back to overview] | Post-Exposure Prophylaxis Medication Adherence |
NCT00856323 (4) [back to overview] | HIV-related Sexual Risk Behaviors in Previous 30 Days. |
NCT00862823 (2) [back to overview] | Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz |
NCT00862823 (2) [back to overview] | Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz |
NCT00869960 (8) [back to overview] | Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00869960 (8) [back to overview] | Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00869960 (8) [back to overview] | Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00869960 (8) [back to overview] | Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses) |
NCT00869960 (8) [back to overview] | Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses) |
NCT00885664 (11) [back to overview] | SF-12 Physical Capacity Score |
NCT00885664 (11) [back to overview] | INF Gamma |
NCT00885664 (11) [back to overview] | IL-8 |
NCT00885664 (11) [back to overview] | IL-7 |
NCT00885664 (11) [back to overview] | IL-6 |
NCT00885664 (11) [back to overview] | IL-4 |
NCT00885664 (11) [back to overview] | IL-10 |
NCT00885664 (11) [back to overview] | IL-1 Beta |
NCT00885664 (11) [back to overview] | SF-12 Mental Capacity Score |
NCT00885664 (11) [back to overview] | TNF Alpha |
NCT00885664 (11) [back to overview] | Symptom Score |
NCT00924898 (6) [back to overview] | Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications |
NCT00924898 (6) [back to overview] | Number of Participants Without Virologic Failure at Week 24 |
NCT00924898 (6) [back to overview] | Number of Participants Without Virologic Failure at Week 48 |
NCT00924898 (6) [back to overview] | Number of Participants With HIV RNA Suppression at Week 96 |
NCT00924898 (6) [back to overview] | Time to HIV RNA Suppression <50 Copies/mL |
NCT00924898 (6) [back to overview] | Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment |
NCT00928187 (13) [back to overview] | Development of Metabolic Syndrome |
NCT00928187 (13) [back to overview] | Adherence |
NCT00928187 (13) [back to overview] | Gain in CD4 Cells Between Baseline and W48 |
NCT00928187 (13) [back to overview] | Number of Patients Discontinuing Study Treatment |
NCT00928187 (13) [back to overview] | Number of Patients With HIV Plasma Viral Load < 200 Copies/ml |
NCT00928187 (13) [back to overview] | Number of Patients With HIV Plasma Viral Load < 50 Copies/ml |
NCT00928187 (13) [back to overview] | Number of Patients With Plasma HIV RNA < 50 Copies/mL |
NCT00928187 (13) [back to overview] | Number of Patients With Resistance Mutations |
NCT00928187 (13) [back to overview] | Patients With Plasma HIV RNA < 200 Copies/ml |
NCT00928187 (13) [back to overview] | Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate) |
NCT00928187 (13) [back to overview] | Tolerance: Gastrointestinal Complains |
NCT00928187 (13) [back to overview] | Tolerance: Neuropathies (Grade 1 to 4) |
NCT00928187 (13) [back to overview] | Number of Patients With WHO Stage 3 and 4 HIV Related Events |
NCT00931801 (4) [back to overview] | Maintenance of Virologic Suppression |
NCT00931801 (4) [back to overview] | Change in Quality of Life From Baseline to 48 Weeks of Study Treatment |
NCT00931801 (4) [back to overview] | The Difference in CD4 From Baseline to Week 48 |
NCT00931801 (4) [back to overview] | The Change in Adherence to Study Treatment Arm From Baseline to Week 48 |
NCT00959894 (25) [back to overview] | Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24 |
NCT00959894 (25) [back to overview] | Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State |
NCT00959894 (25) [back to overview] | The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy |
NCT00959894 (25) [back to overview] | Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results |
NCT00959894 (25) [back to overview] | Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults |
NCT00959894 (25) [back to overview] | Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Glucose Metabolism (Insulin Resistance), in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in the Lipid Profile and Glucose Metabolism, in a Subgroup of up to 40 Participants, From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00959894 (25) [back to overview] | Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine |
NCT00960622 (1) [back to overview] | Change in Peak Oxygen Uptake. |
NCT01003990 (1) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death |
NCT01025427 (1) [back to overview] | Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24 |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4 |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8 |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Actual Number of Study Visits Completed by 24 Weeks |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Overall |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 12 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 16 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 20 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 4 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Medication Refill Dates-Week 8 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 12 |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Ran Out of Study Pills |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Felt Sick or Ill |
NCT01033942 (96) [back to overview] | Acceptability of Risk Reduction Counseling at Every Visit |
NCT01033942 (96) [back to overview] | Acceptability of Questions About Sexual Behavior at Every Visit |
NCT01033942 (96) [back to overview] | Acceptability of Physical Examination by a Doctor |
NCT01033942 (96) [back to overview] | Acceptability of Participating in Group Sessions |
NCT01033942 (96) [back to overview] | Acceptability of Health Clinic for Study Visits |
NCT01033942 (96) [back to overview] | Acceptability of Having an HIV Test at Every Visit |
NCT01033942 (96) [back to overview] | Acceptability of Being Randomly Assigned to a Group |
NCT01033942 (96) [back to overview] | Acceptability of Being Contacted by the Research Team in Between Visits |
NCT01033942 (96) [back to overview] | Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8 |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications |
NCT01033942 (96) [back to overview] | Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful |
NCT01033942 (96) [back to overview] | Acceptability of the Taste of the Pill |
NCT01033942 (96) [back to overview] | Acceptability of the Color of the Pill |
NCT01033942 (96) [back to overview] | Acceptability of Taking the Pill Everyday |
NCT01033942 (96) [back to overview] | Acceptability of Taking Part in the Study |
NCT01033942 (96) [back to overview] | Acceptability of Size of Pill |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Simply Forgot |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 8 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Over Time Based on Self-Report Calendar Data |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 24 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 20 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 16 |
NCT01033942 (96) [back to overview] | Number of Missed Doses Based on Self-Report Calendar Data-Week 4 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16 |
NCT01033942 (96) [back to overview] | Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20 |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Was Away From Home |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 12 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 16 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 20 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 24 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 4 |
NCT01033942 (96) [back to overview] | Perceived Risk of Becoming HIV Positive at Week 8 |
NCT01033942 (96) [back to overview] | Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things |
NCT01033942 (96) [back to overview] | Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12 |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Obstetrical Complications |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of HIV/AIDS-related Event or World Health Organization (WHO) Clinical Stage 2 or 3 Events |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of Tuberculosis |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence Rate of Cardiovascular or Other Metabolic Events |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Obstetrical Complications |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) |
NCT01061151 (28) [back to overview] | Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery |
NCT01061151 (28) [back to overview] | Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events |
NCT01061151 (28) [back to overview] | Postpartum Component: Incidence of Confirmed Infant HIV Infection |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of HIV/AIDS-related Events |
NCT01061151 (28) [back to overview] | Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results |
NCT01061151 (28) [back to overview] | Maternal Health Component: Other Targeted Medical Conditions |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of HIV/AIDS-related Event or Death |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of Death |
NCT01061151 (28) [back to overview] | Maternal Health Component: Incidence of AIDS-defining Illness |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Infant HIV Infections |
NCT01061151 (28) [back to overview] | Antepartum Component: Number of Confirmed Infant HIV Infections |
NCT01061151 (28) [back to overview] | Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures |
NCT01061151 (28) [back to overview] | Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery |
NCT01061151 (28) [back to overview] | Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery |
NCT01061151 (28) [back to overview] | Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) |
NCT01061151 (28) [back to overview] | Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component) |
NCT01140880 (4) [back to overview] | Course Completion |
NCT01140880 (4) [back to overview] | Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine) |
NCT01140880 (4) [back to overview] | Time From Exposure to Truvada Initiation |
NCT01140880 (4) [back to overview] | Medication Adherence |
NCT01154673 (1) [back to overview] | Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART. |
NCT01195467 (2) [back to overview] | The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment |
NCT01195467 (2) [back to overview] | The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment |
NCT01214759 (2) [back to overview] | Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study |
NCT01214759 (2) [back to overview] | Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months |
NCT01270802 (2) [back to overview] | Change in Flow-mediated Dilation (FMD) of the Brachial Artery |
NCT01270802 (2) [back to overview] | Change in Serum Levels of Vitamin D |
NCT01285050 (1) [back to overview] | HCV RNA |
NCT01327651 (28) [back to overview] | The Total Pills Actually Used Over the Follow-up Period |
NCT01327651 (28) [back to overview] | The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data |
NCT01327651 (28) [back to overview] | The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews) |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm |
NCT01327651 (28) [back to overview] | Self-reported Side Effect or Symptom Scores |
NCT01327651 (28) [back to overview] | Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing |
NCT01327651 (28) [back to overview] | Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell) |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study |
NCT01327651 (28) [back to overview] | A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm |
NCT01332227 (7) [back to overview] | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24 |
NCT01332227 (7) [back to overview] | Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs |
NCT01332227 (7) [back to overview] | Number of Participants With Virologic Rebound at Weeks 24 and 48 |
NCT01332227 (7) [back to overview] | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48 |
NCT01332227 (7) [back to overview] | Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24 |
NCT01332227 (7) [back to overview] | Mean Changes in Fasting Lipid Levels From Baseline to Week 48 |
NCT01332227 (7) [back to overview] | Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48 |
NCT01335620 (2) [back to overview] | Drug Levels in Blood |
NCT01335620 (2) [back to overview] | Cerebral Function; Changes in Global Cognitive Z-score |
NCT01338025 (4) [back to overview] | Number of Participants Non-adherent as Measured by 3-day Recall |
NCT01338025 (4) [back to overview] | Number of Participants With Immunologic Deterioration |
NCT01338025 (4) [back to overview] | Change in CD4+ T Cell Count |
NCT01338025 (4) [back to overview] | Change in HIV-1 RNA Levels |
NCT01345630 (25) [back to overview] | Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF). |
NCT01345630 (25) [back to overview] | Tropism Change Between Screening or Baseline and PDTF |
NCT01345630 (25) [back to overview] | Severity of Abnormal Laboratory Values |
NCT01345630 (25) [back to overview] | Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%) |
NCT01345630 (25) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL. |
NCT01345630 (25) [back to overview] | Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%) |
NCT01345630 (25) [back to overview] | Number of Treatment-related AEs |
NCT01345630 (25) [back to overview] | Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48 |
NCT01345630 (25) [back to overview] | Frequency of Adverse Events (AE). |
NCT01345630 (25) [back to overview] | Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria. |
NCT01345630 (25) [back to overview] | Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria |
NCT01345630 (25) [back to overview] | Number of Participants With Abnormal Laboratory Values |
NCT01345630 (25) [back to overview] | Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48 |
NCT01345630 (25) [back to overview] | Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3) |
NCT01345630 (25) [back to overview] | Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3) |
NCT01345630 (25) [back to overview] | Number of Participants With Treatment-emergent Serious Adverse Events |
NCT01345630 (25) [back to overview] | Number of Participants With Grade 3 or 4 AEs |
NCT01345630 (25) [back to overview] | Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48. |
NCT01345630 (25) [back to overview] | Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD |
NCT01345630 (25) [back to overview] | Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD |
NCT01345630 (25) [back to overview] | Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD |
NCT01345630 (25) [back to overview] | Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1) |
NCT01345630 (25) [back to overview] | Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin |
NCT01345630 (25) [back to overview] | The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA). |
NCT01345630 (25) [back to overview] | Number of Participants Who Discontinued Due to AEs |
NCT01352117 (12) [back to overview] | Cumulative Incidence of Initial KS Partial or Complete Response by Week 96 |
NCT01352117 (12) [back to overview] | Percentage of Participants With ARV Dose Modification |
NCT01352117 (12) [back to overview] | Percentage of Participants With HIV-1 RNA Suppression |
NCT01352117 (12) [back to overview] | Percentage of Participants With Etoposide Dose Modification |
NCT01352117 (12) [back to overview] | Change in Peripheral Blood CD4+ Lymphocyte Cell Count |
NCT01352117 (12) [back to overview] | Change in Peripheral Blood CD4+ Lymphocyte Cell Count |
NCT01352117 (12) [back to overview] | Number of Participants With Grade 3 or Higher Adverse Events |
NCT01352117 (12) [back to overview] | Cumulative Incidence of KS-IRIS |
NCT01352117 (12) [back to overview] | Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A |
NCT01352117 (12) [back to overview] | Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A |
NCT01352117 (12) [back to overview] | Percentage of Participants With HIV-1 RNA Suppression |
NCT01352117 (12) [back to overview] | Cumulative Incidence of Initial KS Progressive Disease by Week 96 |
NCT01352715 (9) [back to overview] | Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure |
NCT01352715 (9) [back to overview] | Percentage of Time Spent in Hospital |
NCT01352715 (9) [back to overview] | Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline |
NCT01352715 (9) [back to overview] | Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death |
NCT01352715 (9) [back to overview] | Number of Participants With a New AIDS-defining Events or Death |
NCT01352715 (9) [back to overview] | Number of Participants Discontinuing Randomized Treatment for Toxicity |
NCT01352715 (9) [back to overview] | Cumulative Probability of Virologic Failure by Week 48 |
NCT01352715 (9) [back to overview] | Change in CD4+ Cell Count From Baseline to Week 48 |
NCT01352715 (9) [back to overview] | Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline |
NCT01400412 (20) [back to overview] | Number of Participants Who Died During the Study |
NCT01400412 (20) [back to overview] | Number of Participants Who Experienced Bone Fractures |
NCT01400412 (20) [back to overview] | Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) |
NCT01400412 (20) [back to overview] | Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percent Change in Lumbar Spine Bone Mineral Density (BMD) |
NCT01400412 (20) [back to overview] | Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | CD8+ T-cell Change From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Change in CD4 Count From Baseline to Week 24 |
NCT01400412 (20) [back to overview] | Change in CD4 Count From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Change in Level of IP-10 From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Change in Levels of D-dimer From Baseline |
NCT01400412 (20) [back to overview] | Change in Levels of IL-6 From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Change in Levels of sCD14 From Baseline |
NCT01400412 (20) [back to overview] | Cumulative Probability of Virologic Failure by Week 48 |
NCT01400412 (20) [back to overview] | Change in Levels of sCD163 From Baseline to Week 48 |
NCT01400412 (20) [back to overview] | Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events |
NCT01435018 (37) [back to overview] | Duration of Objective Response for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Duration of Objective Response for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death for BV+ART vs PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Objective Response for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With Objective Response for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART |
NCT01435018 (37) [back to overview] | Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2 |
NCT01435018 (37) [back to overview] | Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3 |
NCT01435018 (37) [back to overview] | Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4 |
NCT01435018 (37) [back to overview] | Number of Participants With Peripheral Neuropathy (PN) |
NCT01435018 (37) [back to overview] | Number of Participants With Symptomatic Peripheral Neuropathy (SPN) |
NCT01435018 (37) [back to overview] | Number of Participants With Treatment-related Toxicities and Adverse Events (AEs) |
NCT01435018 (37) [back to overview] | Self-reported Adherence to ART Therapy |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Week - 52 Weeks |
NCT01450189 (30) [back to overview] | Number of Partners Reporting for HIV Testing |
NCT01450189 (30) [back to overview] | Proportion of Participants Completing Full Course of ARVs in Arm BIA |
NCT01450189 (30) [back to overview] | Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment. |
NCT01450189 (30) [back to overview] | Proportion of Partners Reporting for HIV Testing |
NCT01450189 (30) [back to overview] | Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening |
NCT01450189 (30) [back to overview] | Proportion of Persons Completing All Scheduled Visits in Each Study Arm |
NCT01450189 (30) [back to overview] | Proportion of Persons With AHI Successfully Recruited Into the Study |
NCT01450189 (30) [back to overview] | Suppression of HIV RNA to <1000c/ml at 12 Weeks |
NCT01450189 (30) [back to overview] | Prevalence of AHI Among Persons Screened |
NCT01450189 (30) [back to overview] | Time to HIV RNA Suppression <1000 c/ml |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Month - 12 Weeks |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Month - 26 Weeks |
NCT01450189 (30) [back to overview] | Blood HIV RNA Concentration at Week 52 |
NCT01450189 (30) [back to overview] | Cumulative Incidence Herpes Simplex Virus Type 2 |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Week - 26 Weeks |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 12, Men |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Week - 12 Weeks |
NCT01450189 (30) [back to overview] | Unprotected Sex Acts in Previous One Month - 52 Weeks |
NCT01450189 (30) [back to overview] | Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) |
NCT01450189 (30) [back to overview] | Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 12, Women |
NCT01450189 (30) [back to overview] | Cumulative Incidence Herpes Simplex Virus Type 2 |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 26, Men |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 26, Women |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 52, Men |
NCT01450189 (30) [back to overview] | Genital HIV RNA Concentration - Week 52, Women |
NCT01450189 (30) [back to overview] | Blood HIV RNA Concentration at Week 26 |
NCT01450189 (30) [back to overview] | Number of Adverse Events |
NCT01450189 (30) [back to overview] | Blood HIV RNA Concentration at Week 12 |
NCT01505114 (1) [back to overview] | Occurrence of Grade 3 or Higher Adverse Events (AEs) |
NCT01605890 (12) [back to overview] | Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48 |
NCT01605890 (12) [back to overview] | Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24 |
NCT01605890 (12) [back to overview] | Number of Virological Failure Participants With Resistance Mutations |
NCT01605890 (12) [back to overview] | Number of Participants With Treatment Switch or Discontinuation |
NCT01605890 (12) [back to overview] | Number of Clinical and Biological Events |
NCT01605890 (12) [back to overview] | Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL |
NCT01605890 (12) [back to overview] | Number of Participants With Clinical Progression |
NCT01605890 (12) [back to overview] | Median Change in CD4 Lymphocytes Count at Week 12 |
NCT01605890 (12) [back to overview] | Percentage of Participants in Therapeutic Success |
NCT01605890 (12) [back to overview] | Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire |
NCT01605890 (12) [back to overview] | Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence |
NCT01605890 (12) [back to overview] | Median Change of CD4 Lymphocytes at Week 48 |
NCT01632891 (7) [back to overview] | Change in log10(Pf Parasite Density) From Entry to Day 30 |
NCT01632891 (7) [back to overview] | Number of Participants With Uncomplicated Clinical Malaria |
NCT01632891 (7) [back to overview] | Time to First Pf SCP Clearance |
NCT01632891 (7) [back to overview] | Number of Participants With Detectable Pf Gametocyte Density |
NCT01632891 (7) [back to overview] | Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance |
NCT01632891 (7) [back to overview] | Log10(Pf Parasite Density) |
NCT01632891 (7) [back to overview] | Change in log10(Pf Gametocyte Density) From Entry to Day 30 |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks |
NCT01641367 (60) [back to overview] | Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in CD4+ T-cell Count |
NCT01641367 (60) [back to overview] | Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Triglycerides |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Total Cholesterol |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Glucose |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation. |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing |
NCT01641367 (60) [back to overview] | Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time to First Dose Modification Due to Grade 3 or 4 Toxicity |
NCT01641367 (60) [back to overview] | Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Death or Hospitalization by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With Confirmed Virologic Failure by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death or Hospitalization. |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) |
NCT01641367 (60) [back to overview] | Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Death [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Time From Study Entry/Randomization to Death |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing |
NCT01641367 (60) [back to overview] | Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Number of Weeks of Follow-up |
NCT01641367 (60) [back to overview] | Number of Weeks of Follow-up [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 |
NCT01641367 (60) [back to overview] | Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC] |
NCT01641367 (60) [back to overview] | Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 |
NCT01641809 (57) [back to overview] | Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm |
NCT01641809 (57) [back to overview] | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase |
NCT01641809 (57) [back to overview] | Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm |
NCT01641809 (57) [back to overview] | Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events |
NCT01641809 (57) [back to overview] | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings |
NCT01641809 (57) [back to overview] | Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2 |
NCT01641809 (57) [back to overview] | Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2 |
NCT01641809 (57) [back to overview] | Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2 |
NCT01641809 (57) [back to overview] | Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96 |
NCT01641809 (57) [back to overview] | Change From Baseline in ALT, AST and CK Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in ALT, AST and CK Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in CD4+ Cell Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in CD4+ Cell Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Estimated Creatinine Clearance Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Hemoglobin Level Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Hemoglobin Level Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit |
NCT01641809 (57) [back to overview] | Number of Participants With Adherence to Study Treatment |
NCT01641809 (57) [back to overview] | Number of Participants With Adherence to Study Treatment |
NCT01641809 (57) [back to overview] | Number of Participants With Adherence to Study Treatment |
NCT01641809 (57) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase |
NCT01641809 (57) [back to overview] | Number of Participants With AEs and SAEs Over Time |
NCT01641809 (57) [back to overview] | Number of Participants With AEs and SAEs-Induction Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase |
NCT01641809 (57) [back to overview] | Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease |
NCT01641809 (57) [back to overview] | Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance |
NCT01641809 (57) [back to overview] | Number of Participants With Treatment Emergent Phenotypic Resistance |
NCT01641809 (57) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase |
NCT01641809 (57) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis |
NCT01641809 (57) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma |
NCT01687218 (12) [back to overview] | Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period |
NCT01687218 (12) [back to overview] | Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently? |
NCT01687218 (12) [back to overview] | Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it? |
NCT01687218 (12) [back to overview] | Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product? |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge |
NCT01687218 (12) [back to overview] | Safety: Grade 2 or Higher Adverse Events |
NCT01687218 (12) [back to overview] | Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue |
NCT01687218 (12) [back to overview] | Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue |
NCT01687218 (12) [back to overview] | Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma |
NCT01687218 (12) [back to overview] | Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method. |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48 |
NCT01709084 (6) [back to overview] | Percentage of Participant With Treatment Adherence Based on Tablet Count |
NCT01709084 (6) [back to overview] | Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method. |
NCT01709084 (6) [back to overview] | Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48 |
NCT01769456 (12) [back to overview] | Total Body Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01769456 (12) [back to overview] | Number of Participants Using Text Messaging Reminders |
NCT01769456 (12) [back to overview] | Number of Participants With Decrease in Bone Mineral Density |
NCT01769456 (12) [back to overview] | Acceptability of PrEP Regimen and Study Visits |
NCT01769456 (12) [back to overview] | Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01769456 (12) [back to overview] | Rating of the Reasons for Missing Medications on a 4-point Likert Scale. |
NCT01769456 (12) [back to overview] | Estimation of Medication Adherence by Dried Blood Spot (DBS) Results |
NCT01769456 (12) [back to overview] | Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners |
NCT01769456 (12) [back to overview] | Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex |
NCT01769456 (12) [back to overview] | Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01769456 (12) [back to overview] | Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48 |
NCT01769456 (12) [back to overview] | Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study |
NCT01772823 (15) [back to overview] | Total Body Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure |
NCT01772823 (15) [back to overview] | Number of Participants With Unprotected Sex Acts |
NCT01772823 (15) [back to overview] | Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 |
NCT01772823 (15) [back to overview] | Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) |
NCT01772823 (15) [back to overview] | Lumbar Spine Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Femoral Neck Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Number of Participants With Serum Creatinine Event of Grade 1 or Higher |
NCT01772823 (15) [back to overview] | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load) |
NCT01772823 (15) [back to overview] | Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) |
NCT01772823 (15) [back to overview] | Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age) |
NCT01772823 (15) [back to overview] | Number of Sex Partners |
NCT01772823 (15) [back to overview] | Total Hip Bone Mineral Density at Baseline and at Week 48 |
NCT01772823 (15) [back to overview] | Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders |
NCT01772823 (15) [back to overview] | Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders |
NCT01777997 (9) [back to overview] | Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs) |
NCT01777997 (9) [back to overview] | Change in CD4+ T-cell Count |
NCT01777997 (9) [back to overview] | Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) |
NCT01777997 (9) [back to overview] | Change in Levels of Interleukin (IL)-6 |
NCT01777997 (9) [back to overview] | Change in Quality of Life (QoL) Index |
NCT01777997 (9) [back to overview] | Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay |
NCT01777997 (9) [back to overview] | Change in Levels of D-dimer |
NCT01777997 (9) [back to overview] | Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART |
NCT01777997 (9) [back to overview] | Change in Levels of CD8+ T-cell Activation |
NCT01781806 (3) [back to overview] | Cohort H PrEP Engagement by Study Visit |
NCT01781806 (3) [back to overview] | Number of HIV Seroconversions by Cohort. |
NCT01781806 (3) [back to overview] | Number of Participants With a Grade 2 or Higher Adverse Event by Cohort |
NCT01803074 (28) [back to overview] | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C |
NCT01803074 (28) [back to overview] | Plasma Concentration 24 Hours Post-Dose (C24) - Part B |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline |
NCT01803074 (28) [back to overview] | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B |
NCT01803074 (28) [back to overview] | Apparent Total Body Clearance: Part A and C |
NCT01803074 (28) [back to overview] | Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C |
NCT01803074 (28) [back to overview] | Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 |
NCT01803074 (28) [back to overview] | Degree of Fluctuation (DF): Part A and C |
NCT01803074 (28) [back to overview] | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C |
NCT01803074 (28) [back to overview] | Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Changes in Heart Rate |
NCT01803074 (28) [back to overview] | Plasma Half-life: Part A and C |
NCT01803074 (28) [back to overview] | Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C |
NCT01803074 (28) [back to overview] | Time to Maximum Decline in Log 10 HIV-1 RNA - Part B |
NCT01803074 (28) [back to overview] | Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C |
NCT01803074 (28) [back to overview] | Accumulation Index (AI): Part A and C |
NCT01803074 (28) [back to overview] | Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C |
NCT01803074 (28) [back to overview] | Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B |
NCT01803074 (28) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C |
NCT01803074 (28) [back to overview] | Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B |
NCT01803074 (28) [back to overview] | Maximum Observed Plasma Concentrations (Cmax) - Part A and C |
NCT01803074 (28) [back to overview] | Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study |
NCT01803074 (28) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) - Part B |
NCT01803074 (28) [back to overview] | Maximum Observed Plasma Concentrations (Cmax) - Part B |
NCT01803074 (28) [back to overview] | Number of Participants With Abnormal Changes in Physical Examination |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) |
NCT01803074 (28) [back to overview] | Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
NCT01803074 (28) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C |
NCT01855867 (3) [back to overview] | Number of Participants With Self-Reported Missed Doses |
NCT01855867 (3) [back to overview] | Number of Adverse Event Occurrences |
NCT01855867 (3) [back to overview] | nPEP Failure (HIV Infection During Study Participation) |
NCT01869634 (4) [back to overview] | Change in Systemic Immune Activation |
NCT01869634 (4) [back to overview] | Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV |
NCT01869634 (4) [back to overview] | Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV |
NCT01869634 (4) [back to overview] | Change in Percentage of Total Artery Diameter |
NCT01910402 (48) [back to overview] | Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase |
NCT01910402 (48) [back to overview] | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase |
NCT01910402 (48) [back to overview] | Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase |
NCT01910402 (48) [back to overview] | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups |
NCT01910402 (48) [back to overview] | Change From Baseline in TC/HDL Ratio at Week 48 |
NCT01910402 (48) [back to overview] | Change From Baseline in Triglycerides at Week 48 |
NCT01910402 (48) [back to overview] | Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 |
NCT01910402 (48) [back to overview] | Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase |
NCT01910402 (48) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) |
NCT01910402 (48) [back to overview] | Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) |
NCT01910402 (48) [back to overview] | Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Any AEs, and SAEs in Continuation Phase |
NCT01910402 (48) [back to overview] | Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With AEs by Maximum Toxicity-Randomized Phase |
NCT01910402 (48) [back to overview] | Number of Participants With AEs by Maximum Toxicity-Continuation Phase |
NCT01910402 (48) [back to overview] | HIVTSQs Total Score at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 |
NCT01910402 (48) [back to overview] | Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in Hematocrit Count at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Erythrocytes at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Creatinine Clearance at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase |
NCT01910402 (48) [back to overview] | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Lipase at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline in Albumin at Indicated Timepoints |
NCT01910402 (48) [back to overview] | Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points |
NCT01910402 (48) [back to overview] | Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS |
NCT01910402 (48) [back to overview] | Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline |
NCT01929759 (8) [back to overview] | Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS) |
NCT01929759 (8) [back to overview] | Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8 |
NCT01929759 (8) [back to overview] | Effect of EFV and Its Metabolites |
NCT01929759 (8) [back to overview] | Fasting Lipid Profile |
NCT01929759 (8) [back to overview] | Sleep Quality |
NCT01929759 (8) [back to overview] | Neurocognitive Changes |
NCT01929759 (8) [back to overview] | Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI) |
NCT01929759 (8) [back to overview] | Markers of Immune Activation |
NCT02022657 (1) [back to overview] | Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada |
NCT02116660 (1) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) |
NCT02180438 (12) [back to overview] | Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events |
NCT02180438 (12) [back to overview] | Grade 3 or 4 Adverse Events |
NCT02180438 (12) [back to overview] | Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml) |
NCT02180438 (12) [back to overview] | Switching Off Stribild Prior to 48 Weeks |
NCT02180438 (12) [back to overview] | Death |
NCT02180438 (12) [back to overview] | New WHO Stage 3 or 4 Event |
NCT02180438 (12) [back to overview] | Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event |
NCT02180438 (12) [back to overview] | Interim Analysis at 24 Weeks of HIV-2 Virologic Failure |
NCT02180438 (12) [back to overview] | Interim 24 Weeks Analysis of Death |
NCT02180438 (12) [back to overview] | Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF |
NCT02180438 (12) [back to overview] | CD4 T-cell Count at 48 Weeks < Baseline |
NCT02180438 (12) [back to overview] | < 50 CD4 T-cell Increase at 48 Weeks From Baseline |
NCT02213328 (11) [back to overview] | Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit |
NCT02213328 (11) [back to overview] | Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events |
NCT02213328 (11) [back to overview] | Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period |
NCT02213328 (11) [back to overview] | Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP |
NCT02213328 (11) [back to overview] | Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52 |
NCT02213328 (11) [back to overview] | Number of Adolescents Enrolled and Retained in the Study |
NCT02213328 (11) [back to overview] | Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit |
NCT02213328 (11) [back to overview] | Number of Participants With Acceptability as Per Questionnaire Administered at Week 48 |
NCT02213328 (11) [back to overview] | Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36 |
NCT02213328 (11) [back to overview] | Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment |
NCT02213328 (11) [back to overview] | The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package |
NCT02251236 (4) [back to overview] | Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline |
NCT02251236 (4) [back to overview] | Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24 |
NCT02251236 (4) [back to overview] | Concentration of Tenofovir in Cerebrospinal Fluid at Baseline |
NCT02251236 (4) [back to overview] | Concentration of Tenofovir in Cerebrospinal Fluid at Week 24 |
NCT02401230 (13) [back to overview] | Median Plasma Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Plasma Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Percentage of CD4 Positive T-Cells |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Cumulative Amount of p24 |
NCT02401230 (13) [back to overview] | Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Secretion Emtricitabine (FTC) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Secretion Tenofovir (TDF) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration |
NCT02401230 (13) [back to overview] | Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration |
NCT02431247 (64) [back to overview] | Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96 |
NCT02431247 (64) [back to overview] | Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates |
NCT02431247 (64) [back to overview] | Percentage of Participants With PDVF Post-week 96 to End of Extension |
NCT02431247 (64) [back to overview] | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) |
NCT02431247 (64) [back to overview] | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) |
NCT02431247 (64) [back to overview] | Percentage of Participants With Protocol-defined Virologic Failure (PDVF) |
NCT02431247 (64) [back to overview] | Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates |
NCT02431247 (64) [back to overview] | Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates |
NCT02431247 (64) [back to overview] | Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD) |
NCT02431247 (64) [back to overview] | Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide |
NCT02431247 (64) [back to overview] | Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir |
NCT02431247 (64) [back to overview] | Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in log10 HIV-1 RNA Levels at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Serum Creatinine at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48 |
NCT02431247 (64) [back to overview] | Change From Reference in ALP Levels |
NCT02431247 (64) [back to overview] | Change From Reference in CD4+ Cell Count at Week 96 |
NCT02431247 (64) [back to overview] | Change From Reference in eGFRcr by CKD-EPI Formula |
NCT02431247 (64) [back to overview] | Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula |
NCT02431247 (64) [back to overview] | Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of 25-OH Vitamin D |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of PTH |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of Serum CTX |
NCT02431247 (64) [back to overview] | Change From Reference in Levels of Serum P1NP |
NCT02431247 (64) [back to overview] | Change From Reference in log10 HIV-1 RNA Levels at Week 96 |
NCT02431247 (64) [back to overview] | Change From Reference in Serum Creatinine |
NCT02431247 (64) [back to overview] | Change From Reference in UACR |
NCT02431247 (64) [back to overview] | Change From Reference in UB2MGCR |
NCT02431247 (64) [back to overview] | Change From Reference in UPCR |
NCT02431247 (64) [back to overview] | Change From Reference in URBPCR |
NCT02431247 (64) [back to overview] | Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48 |
NCT02431247 (64) [back to overview] | Percent Change From Reference in Urine FEPO4 |
NCT02431247 (64) [back to overview] | Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach |
NCT02431247 (64) [back to overview] | Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach |
NCT02431247 (64) [back to overview] | Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide |
NCT02431247 (64) [back to overview] | Predose (Trough) Plasma Concentration (C0h) of Darunavir |
NCT02431247 (64) [back to overview] | CD4+ Cell Count Post-Week From 96 to End of Extension |
NCT02431247 (64) [back to overview] | Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in BMD T-score of Hip and Spine |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48 |
NCT02431247 (64) [back to overview] | Change From Reference in BMD T-score of Hip and Spine at Week 96 |
NCT02431247 (64) [back to overview] | Number of Participants With ARV Resistance |
NCT02431247 (64) [back to overview] | Percent Change From Reference in Hip and Spine BMD |
NCT02431247 (64) [back to overview] | Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability |
NCT02431247 (64) [back to overview] | Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability |
NCT02431247 (64) [back to overview] | Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability |
NCT02431247 (64) [back to overview] | Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48 |
NCT02495779 (1) [back to overview] | Number of Participants With PrEP Adherence |
NCT02556333 (1) [back to overview] | HIV RNA Change From Baseline to Day 10 |
NCT02603120 (7) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm |
NCT02603120 (7) [back to overview] | Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm |
NCT02603120 (7) [back to overview] | Spine Bone Mineral Density (BMD) at Baseline |
NCT02603120 (7) [back to overview] | Change From Baseline in CD4+ Cell Count at Week 48 |
NCT02603120 (7) [back to overview] | Hip Bone Mineral Density at Baseline |
NCT02603120 (7) [back to overview] | Percentage Change From Baseline in Hip BMD at Week 48 |
NCT02603120 (7) [back to overview] | Percentage Change From Baseline in Spine BMD at Week 48 |
NCT02815566 (2) [back to overview] | Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine |
NCT02815566 (2) [back to overview] | % Change in Bone Mineral Density From Baseline at the Femoral Neck |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 |
NCT02831673 (64) [back to overview] | CD4+ Cell Counts at Week 96 |
NCT02831673 (64) [back to overview] | CD4+ Cell Counts at Week 144 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 |
NCT02831673 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 |
NCT02831673 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 |
NCT02831673 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831673 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With HIV-1 Disease Progression up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants With Any AE and SAE up to Week 148 |
NCT02831673 (64) [back to overview] | Number of Participants With AEs by Maximum Severity Grades up to Week 144 |
NCT02831673 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 |
NCT02831673 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 |
NCT02831673 (64) [back to overview] | CD4+ Cell Counts at Weeks 24 and 48 |
NCT02831673 (64) [back to overview] | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831673 (64) [back to overview] | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 |
NCT02831673 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96 |
NCT02831764 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 |
NCT02831764 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831764 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Number of Participants With AEs by Maximum Severity Grades up to Week 148 |
NCT02831764 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | CD4+ Cell Counts at Weeks 24 and 48 |
NCT02831764 (64) [back to overview] | Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96 |
NCT02831764 (64) [back to overview] | Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants Who Discontinue Treatment Due to AEs Over Week 144 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 96 |
NCT02831764 (64) [back to overview] | Changes From Baseline in CD4+ Cell Counts at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum RBP at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 |
NCT02831764 (64) [back to overview] | Number of Participants With HIV-1 Disease Progression up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 |
NCT02831764 (64) [back to overview] | Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96 |
NCT02831764 (64) [back to overview] | Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144 |
NCT02831764 (64) [back to overview] | CD4+ Cell Counts at Week 96 |
NCT02831764 (64) [back to overview] | Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 |
NCT02831764 (64) [back to overview] | CD4+ Cell Counts at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144 |
NCT02831764 (64) [back to overview] | Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 144 |
NCT02831764 (64) [back to overview] | Change From Baseline in EQ-5D-5L Utility Score at Week 96 |
NCT02859558 (4) [back to overview] | HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry |
NCT02859558 (4) [back to overview] | Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) |
NCT02859558 (4) [back to overview] | HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry |
NCT02859558 (4) [back to overview] | Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation |
NCT02962739 (1) [back to overview] | Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy |
NCT02968576 (2) [back to overview] | Peak Plasma Concentration (Cmax) |
NCT02968576 (2) [back to overview] | Area Under the Concentration-time Curve (AUC) |
NCT03048422 (23) [back to overview] | Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery |
NCT03048422 (23) [back to overview] | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm |
NCT03048422 (23) [back to overview] | Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure |
NCT03048422 (23) [back to overview] | Percentage of Mother-Infant Pairs With Preterm Deliveries |
NCT03048422 (23) [back to overview] | Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly |
NCT03048422 (23) [back to overview] | Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome |
NCT03048422 (23) [back to overview] | Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome |
NCT03048422 (23) [back to overview] | Percentage of Infants Born Small for Gestational Age |
NCT03048422 (23) [back to overview] | Maternal Change in Creatinine Clearance |
NCT03048422 (23) [back to overview] | Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infant HIV-infection |
NCT03048422 (23) [back to overview] | Cumulative Probability of Infant Deaths |
NCT03048422 (23) [back to overview] | Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis |
NCT03048422 (23) [back to overview] | Change in Maternal Weight Postpartum |
NCT03048422 (23) [back to overview] | Change in Maternal Weight Antepartum |
NCT03048422 (23) [back to overview] | Change in Maternal Weight Overall |
NCT03048422 (23) [back to overview] | Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery |
NCT03048422 (23) [back to overview] | Infant Creatinine Clearance |
NCT03126370 (6) [back to overview] | Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR |
NCT03126370 (6) [back to overview] | Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks |
NCT03126370 (6) [back to overview] | Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks |
NCT03126370 (6) [back to overview] | Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) |
NCT03126370 (6) [back to overview] | Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio |
NCT03126370 (6) [back to overview] | Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR |
NCT03164564 (2) [back to overview] | Number of Pariicipants With Documented Incident HIV Infections |
NCT03164564 (2) [back to overview] | Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2 |
NCT03202511 (2) [back to overview] | PBMC TFV-DP AUC GMR |
NCT03202511 (2) [back to overview] | Plasma TFV AUC0-INF GMR |
NCT03218592 (4) [back to overview] | Whole Blood Antiretroviral Concentrations |
NCT03218592 (4) [back to overview] | Plasma Antiretroviral Concentrations |
NCT03218592 (4) [back to overview] | Peripheral Blood Mononuclear Cells (PBMC) Antiretroviral Concentrations |
NCT03218592 (4) [back to overview] | Hair Antiretroviral Imaging |
NCT03387462 (4) [back to overview] | DOT Diary Mobile App Ease of Use |
NCT03387462 (4) [back to overview] | Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP |
NCT03387462 (4) [back to overview] | DOT Diary Mobile App Acceptability |
NCT03387462 (4) [back to overview] | Assessment of Situations and Reasons for Sub-optimal Use of the App |
NCT03512964 (4) [back to overview] | Number of Patients Offered Rapid HIV Treatment Initiation |
NCT03512964 (4) [back to overview] | Number of Patients Who Accepted Rapid HIV Treatment Initiation |
NCT03512964 (4) [back to overview] | Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day |
NCT03512964 (4) [back to overview] | Number of Patients Who Receive Rapid HIV Treatment Initiation |
NCT03593655 (4) [back to overview] | Number of Participant-Visits With No Product Use |
NCT03593655 (4) [back to overview] | Number of Participant-Visits Reporting Acceptability of Study Product |
NCT03593655 (4) [back to overview] | Number of Participants With Grade 2 or Higher Adverse Events (AEs) |
NCT03593655 (4) [back to overview] | Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets |
NCT03656783 (5) [back to overview] | Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L)) |
NCT03656783 (5) [back to overview] | Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL)) |
NCT03656783 (5) [back to overview] | Change in Myocyte Injury and Strain (hs Troponin (in ng/L)) |
NCT03656783 (5) [back to overview] | Change in Global CFR |
NCT03656783 (5) [back to overview] | Change in Peak Stress Global MBF |
NCT03717129 (9) [back to overview] | FTC Cmax |
NCT03717129 (9) [back to overview] | EVG Half-life |
NCT03717129 (9) [back to overview] | AUC0-∞ for Tenofovir (TFV) |
NCT03717129 (9) [back to overview] | AUC0-∞ for FTC |
NCT03717129 (9) [back to overview] | Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG |
NCT03717129 (9) [back to overview] | FTC Half-life |
NCT03717129 (9) [back to overview] | TFV Half-life |
NCT03717129 (9) [back to overview] | TFV Cmax |
NCT03717129 (9) [back to overview] | EVG Cmax |
NCT03797014 (10) [back to overview] | HBV DNA at Week 48 |
NCT03797014 (10) [back to overview] | CD4 Cell Count Change at Week 48 |
NCT03797014 (10) [back to overview] | HBeAg Loss at Week 48 |
NCT03797014 (10) [back to overview] | HIV-1 RNA at Week 24 |
NCT03797014 (10) [back to overview] | HBsAg Loss at Week 48 |
NCT03797014 (10) [back to overview] | CD4 Cell Count Change at Week 24 |
NCT03797014 (10) [back to overview] | HIV-1 RNA at Week 48 |
NCT03797014 (10) [back to overview] | ALT Normalization at Week 24 |
NCT03797014 (10) [back to overview] | ALT Normalization at Week 48 |
NCT03797014 (10) [back to overview] | HBV DNA at Week 24 |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Heart Rate |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Erythrocytes |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Hematocrit |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Hemoglobin |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of MCH |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of MCV |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in pH of Urine |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Pulse Rate |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Temperature |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Heart Rate |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Pulse Rate |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Temperature |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: Erythrocytes |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: Hematocrit |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: Hemoglobin |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: MCH |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of the Hematology Parameter: MCV |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Blood Pressure |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK) |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Heart Rate |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Erythrocytes |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Hematocrit |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Hemoglobin |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Pulse Rate |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Temperature |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Blood Pressure |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Heart Rate |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of pH of Urine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Pulse Rate |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Specific Gravity of Urine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Temperature |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of pH of Urine |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: Erythrocytes |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: Hematocrit |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: Hemoglobin |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: MCH |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of the Hematology Parameter: MCV |
NCT03836729 (107) [back to overview] | Period 2: Absolute Values of Urine Urobilinogen |
NCT03836729 (107) [back to overview] | Period 2: Change From Baseline in Blood Pressure |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Respiratory Rate |
NCT03836729 (107) [back to overview] | Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) |
NCT03836729 (107) [back to overview] | Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF |
NCT03836729 (107) [back to overview] | Period 1: AUC (0-tau) of FTC |
NCT03836729 (107) [back to overview] | Period 1: AUC (0-tau) of Tenofovir (TFV) |
NCT03836729 (107) [back to overview] | Period 1: Cmax of TFV |
NCT03836729 (107) [back to overview] | Period 1: Ctau of TFV |
NCT03836729 (107) [back to overview] | Period 1: Maximum Observed Concentration (Cmax) of TAF |
NCT03836729 (107) [back to overview] | Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC |
NCT03836729 (107) [back to overview] | Period 1: Tmax of FTC |
NCT03836729 (107) [back to overview] | Period 1: Tmax of TAF |
NCT03836729 (107) [back to overview] | Period 1: Tmax of TFV |
NCT03836729 (107) [back to overview] | Period 1:Cmax of FTC |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of FTC |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of TAF |
NCT03836729 (107) [back to overview] | Period 2: AUC (0-tau) of TFV |
NCT03836729 (107) [back to overview] | Period 2: Cmax of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: Cmax of TAF |
NCT03836729 (107) [back to overview] | Period 2: Cmax of TFV |
NCT03836729 (107) [back to overview] | Period 2: Ctau of FTC |
NCT03836729 (107) [back to overview] | Period 2: Ctau of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: Ctau of TFV |
NCT03836729 (107) [back to overview] | Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 |
NCT03836729 (107) [back to overview] | Period 2: Tmax of FTC |
NCT03836729 (107) [back to overview] | Period 2: Tmax of TAF |
NCT03836729 (107) [back to overview] | Period 2: Tmax of TFV |
NCT03836729 (107) [back to overview] | Period 2:Cmax of FTC |
NCT03836729 (107) [back to overview] | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE) |
NCT03836729 (107) [back to overview] | Period 1: Absolute Values of Blood Pressure |
NCT03917420 (11) [back to overview] | Average Testosterone Concentrations in Serum. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Concentrations in Plasma. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells. |
NCT03917420 (11) [back to overview] | Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03917420 (11) [back to overview] | Average Estradiol Concentrations in Serum. |
NCT03917420 (11) [back to overview] | Average Progesterone Concentrations in Serum. |
NCT03917420 (11) [back to overview] | Average Tenofovir Concentrations in Plasma. |
NCT03917420 (11) [back to overview] | Average Tenofovir Diphosphate Concentrations in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03917420 (11) [back to overview] | Average Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells. |
NCT03917420 (11) [back to overview] | Average Tenofovir Diphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle. |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Tenofovir (TFV) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Emtricitabine (FTC) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03976752 (40) [back to overview] | Plasma Concentration of Elvitegravir (EVG) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Tenofovir (TFN) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP) |
NCT03976752 (40) [back to overview] | Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP) |
NCT03998176 (4) [back to overview] | Percentage of Participants With Grade 3 or Greater Adverse Events |
NCT03998176 (4) [back to overview] | Percentage of Participants With Grade 3 or Greater Adverse Events |
NCT03998176 (4) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm |
NCT03998176 (4) [back to overview] | Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm |
NCT04050371 (3) [back to overview] | Total Testosterone |
NCT04050371 (3) [back to overview] | Estradiol Concentration |
NCT04050371 (3) [back to overview] | Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS) |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal DPV Concentrations From Plasma by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Infant DPV Concentrations From Plasma by Visit |
NCT04140266 (26) [back to overview] | Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations |
NCT04140266 (26) [back to overview] | The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product |
NCT04140266 (26) [back to overview] | Residual Drug Levels in Returned VRs |
NCT04140266 (26) [back to overview] | Geometric Mean of Infant FTC-TP Concentration by Visit |
NCT04140266 (26) [back to overview] | Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N) |
NCT04140266 (26) [back to overview] | Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms |
NCT04140266 (26) [back to overview] | Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms |
NCT04140266 (26) [back to overview] | Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal FTC-TP Concentrations by Visit |
NCT04140266 (26) [back to overview] | Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Infants With Detectable TFV-DP Concentrations |
NCT04140266 (26) [back to overview] | Number and Proportion of Infants With Detectable Plasma DPV Concentrations |
NCT04140266 (26) [back to overview] | Geometric Mean of Infant TFV-DP Concentrations by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit |
NCT04140266 (26) [back to overview] | Geometric Mean of Maternal TFV-DP Concentrations by Visit |
NCT04140266 (26) [back to overview] | Number and Proportion of Infants With Detectable FTC-TP Concentrations |
NCT04233879 (8) [back to overview] | Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 |
NCT04233879 (8) [back to overview] | Change From Baseline in Body Weight at Week 48 |
NCT04233879 (8) [back to overview] | Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48 |
NCT04233879 (8) [back to overview] | Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48 |
NCT04233879 (8) [back to overview] | Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48 |
NCT04318210 (7) [back to overview] | Extracellular Tenofovir (TFV) for Recent Drug Exposure |
NCT04318210 (7) [back to overview] | Self-reported Drug Adherence Over the Past 3 Days |
NCT04318210 (7) [back to overview] | Number of Sex Partners |
NCT04318210 (7) [back to overview] | Number of Sex Acts by Condom Usage |
NCT04318210 (7) [back to overview] | Intracellular Tenofovir-diphosphate (TFV-DP) |
NCT04318210 (7) [back to overview] | HIV Seroconversion |
NCT04318210 (7) [back to overview] | Serious Adverse Events |
Proportion of Participants Who Developed Grade 3 or 4 Adverse Events Attributed to the Study Treatment.
"Adverse events were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004, Clarification August 2009, which is available on the RCC website at (http://rcc.tech-res.com/). Adverse Events of Grade 3 or 4 laboratory abnormalities or signs and symptoms that were judged by the study team to be possibly or probably related to the study treatment.~Comparisons between age groups were not required as per protocol." (NCT00016718)
Timeframe: At study entry, weeks 2 and 4, every 4 weeks up to week 96 and every 6 weeks thereafter for Group 1 participants and at study entry, weeks 2 and 4, every 4 weeks up to week 144 and every 12 weeks thereafter for Groups 2 and 3
Intervention | proportion of participants (Number) |
---|
Age Group 1 | 0.17 |
Age Group 2 | 0.1 |
Age Group 3 | 0.19 |
[back to top]
Proportion of Participants With Suppression of HIV Viral Load to Less Than 400 Copies/ml at Week 16
Proportion was calculated as number of participants with HIV-1 RNA <= 400 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point. (NCT00016718)
Timeframe: At week 16
Intervention | proportion of participants (Number) |
---|
Age Group 1 | 0.83 |
Age Group 2 | 0.86 |
Age Group 3 | 0.81 |
[back to top]
Proportion of Participants With Suppression of HIV Viral Load to Less Than 50 Copies/ml at Week 16
Proportion was calculated as number of participants with HIV-1 RNA <= 50 copies/ml relative to the number of participants with HIV-1 RNA measured at that time point. (NCT00016718)
Timeframe: At week 16
Intervention | proportion of participants (Number) |
---|
Age Group 1 | 0.50 |
Age Group 2 | 0.76 |
Age Group 3 | 0.75 |
[back to top]
Area Under the Curve From 0 to 24 Hours (AUC24) of ARVs for Contraceptive Arms
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC24h (area-under-the-curve from 0 to 24 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8, 12, and 24 hours post dosing.
Intervention | mcg*hr/mL (Median) |
---|
| Before contraceptive initiation | After contraceptive initiation |
---|
ATV/RTV/TFV 300/100/300mg q.d. With ENG | 53.96 | 55.25 |
,EFV 600mg q.d. With ENG | 53.64 | 56.65 |
[back to top]
Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
Intervention | Participants (Count of Participants) |
---|
| 3rd Trimester | Postpartum |
---|
EFV 600mg q.d. | 20 | 21 |
,MVC 150 or 300mg b.i.d. | 8 | 7 |
[back to top]
Number of Women Who Met PK Target of Area Under the Curve (AUC) for ARVs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC (area under the curve) were determined using the linear trapezoidal rule. See PK target in the Protocol Appendix V. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, 12 (and 24) hours post dosing.
Intervention | Participants (Count of Participants) |
---|
| 2nd Trimester | 3rd Trimester | Postpartum |
---|
ATV/RTV Arm 1: 300/100mg q.d. | 1 | 12 | 12 |
,DRV/COBI 800/150 mg q.d. | 3 | 4 | 14 |
,DRV/RTV 600 or 800 or 900/100mg b.i.d. Then 800 or 900/100mg b.i.d. Then 600/100mg b.i.d. | 7 | 16 | 22 |
,DRV/RTV 600/100mg b.i.d. | 7 | 19 | 22 |
,DRV/RTV 800/100mg q.d. | 9 | 19 | 22 |
,DTG 50mg q.d. | 9 | 20 | 23 |
,EFV 600 mg q.d. (Outside THA) | 12 | 33 | 34 |
,ATV/RTV Arm 2: 300/100mg q.d. Then 400/100mg q.d. Then 300/100mg q.d. | 8 | 29 | 27 |
,ETR 200mg b.i.d. | 5 | 13 | 7 |
,EVG/COBI 150/150mg q.d. | 8 | 10 | 18 |
,FPV/RTV 700/100mg b.i.d. | 8 | 26 | 22 |
,IDV/RTV Arm 2: 400/100mg q.d. (Only THA) | 10 | 19 | 26 |
,LPV/RTV Arm 3: 400/100mg b.i.d. Then 600/150mg b.i.d. Then 400/100mg b.i.d. | 9 | 30 | 27 |
,ATV/COBI 300/150 mg q.d. | 1 | 2 | 5 |
,NFV Arm 2: 1250mg b.i.d. Then 1875mg b.i.d. Then 1250mg b.i.d. | NA | 15 | 14 |
,RAL 400mg b.i.d. | 11 | 33 | 30 |
,RPV 25mg q.d. | 14 | 26 | 25 |
,TAF 10mg q.d. w/COBI | 15 | 23 | 22 |
,TAF 25mg q.d. | 13 | 23 | 24 |
,TAF 25mg q.d. w/COBI or RTV Boosting | 10 | 24 | 18 |
,TFV 300mg q.d. | 2 | 27 | 27 |
,TFV/ATV/RTV Arm 1: 300/300/100mg q.d. | 1 | 11 | 12 |
,TFV/ATV/RTV Arm 2: 300/300/100mg q.d. Then 300/400/100mg q.d Then 300/300/100mg q.d. | 7 | 23 | 32 |
[back to top]
Pharmacokinetic (PK) Parameter: Infant Plasma Washout Concentration of ARVs and TB Drugs
Infant plasma concentrations were collected and measured during the first 9 days of life. (NCT00042289)
Timeframe: Blood samples were collected at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
Intervention | mcg/mL (Median) |
---|
| 2-10 hours after birth | 18-28 hours after birth | 36-72 hours after birth | 5-9 days after birth |
---|
DRV/COBI 800/150 mg q.d. | 0.35 | 1.43 | 1.87 | 1.72 |
,DTG 50mg q.d. | 1.73 | 1.53 | 1.00 | 0.06 |
,EFV 600 mg q.d. (Outside THA) | 1.1 | 1.0 | 0.9 | 0.4 |
,EVG/COBI 150/150mg q.d. | 0.132 | 0.032 | 0.005 | 0.005 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
PK Parameter: Area Under the Curve From 0 to 12 Hours (AUC12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing. (NCT00042289)
Timeframe: Measured in 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks, or 6-12 wks postpartum depending on study arm. Blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hrs post dosing.
Intervention | ng*hour/mL (Geometric Mean) |
---|
| 2nd Trimester | 3rd Trimester | Postpartum |
---|
MVC 150 or 300mg b.i.d. | NA | 2717 | 3645 |
[back to top]
[back to top]
PK Parameter: Trough Concentration (C12) With Geometric Mean (95% CI) for ARVs and TB Drugs
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. Trough concentration was the measured concentration from the 12h post-dose sample after an observed dose. (NCT00042289)
Timeframe: Measured at 2nd trimester (20-26 wks gestation), 3rd trimester (30-38 wks gestation), and either 2-3 wks, 2-8 wks or 6-12 wks postpartum depending on study arm. Trough concentration was measured 12 hrs after an observed dose.
Intervention | ng/mL (Geometric Mean) |
---|
| 3rd Trimester | Postpartum |
---|
MVC 150 or 300mg b.i.d. | 108 | 128 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Area Under the Curve From 0 to 12 Hours (AUC12) of ARVs for Contraceptive Arms
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods. AUC12h (area-under-the-curve from 0 to 12 hours) were determined using the linear trapezoidal rule. (NCT00042289)
Timeframe: Measured at 2-12 wks postpartum before contraceptive initiation and 6-7 wks after contraceptive initiation. Blood samples were drawn pre-dose and at 0, 1, 2, 6, 8 and 12 hours post dosing.
Intervention | mcg*hr/mL (Median) |
---|
| Before contraceptive initiation | After contraceptive initiation |
---|
LPV/RTV 400/100 b.i.d. With ENG | 115.97 | 100.20 |
[back to top]
Plasma Concentration for Contraceptives
Serum concentrations of the contraceptives. Note that no historical controls were provided by team pharmacologists and thus no comparisons were done for contraceptive concentrations in women using hormonal contraceptives and selected ARV drugs as compared to historical controls not using those ARV drugs. (NCT00042289)
Timeframe: Measured at 6-7 weeks after contraceptive initiation postpartum
Intervention | pg/mL (Median) |
---|
ATV/RTV/TFV 300/100/300mg q.d. With ENG | 604 |
LPV/RTV 400/100 b.i.d. With ENG | 428 |
EFV 600mg q.d. With ENG | 125 |
[back to top]
[back to top]
[back to top]
Pharmacokinetic (PK) Parameter: Infant Plasma Washout Half-life (T1/2) of ARVs and TB Drugs
Infant plasma concentrations were collected and measured during the first 9 days of life. Half-life is defined as 0.693/k, where k, the elimination rate constant, is the slope of the decline in concentrations. (NCT00042289)
Timeframe: Infant plasma samples at 2-10, 18-28, 36-72 hours and 5-9 days after birth.
Intervention | hour (Median) |
---|
DTG 50mg q.d. | 32.8 |
EVG/COBI 150/150mg q.d. | 7.6 |
DRV/COBI 800/150 mg q.d. | NA |
EFV 600 mg q.d. (Outside THA) | 65.6 |
[back to top]
Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner. (NCT00074581)
Timeframe: Throughout study
Intervention | event rate per 100 person-yr (Number) |
---|
Early-ART | 0.07 |
Delayed-ART | 1.03 |
[back to top]
All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms
All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. (NCT00074581)
Timeframe: Throughout study
Intervention | event rate per 100 person-yr (Number) |
---|
Early-ART | 0.44 |
Delayed-ART | 1.41 |
[back to top]
Time to Immunologic Failure (NRTI Comparison)
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including all follow-up through study closure - May 31,2010)
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile |
---|
TDF/FTC+EFV | 48 | 104 | NA |
,ZDV/3TC+EFV | 48 | 128 | NA |
[back to top]
Time to Immunologic Failure (PI Comparison)
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3. (NCT00084136)
Timeframe: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
ddI+FTC+ATV | 48 | NA |
,ZDV/3TC+EFV | 48 | 112 |
[back to top]
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up through study closure on May 31,2010)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile |
---|
TDF/FTC+EFV | 0 | 24 |
,ZDV/3TC+EFV | 0 | 16 |
[back to top]
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 using follow-up through study closure on May 31,2010
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 0 | 0 | NA |
,ZDV/3TC+EFV | 0 | 0 | 32 |
[back to top]
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 0 | 0 | 48 |
,ZDV/3TC+EFV | 0 | 0 | 32 |
[back to top]
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 (using follow-up through to study closure on May 31,2010)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 0 | 24 | NA |
,ZDV/3TC+EFV | 0 | 16 | NA |
[back to top]
Time to Treatment Failure (PI Comparison)
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 16 | 24 | 120 |
,ZDV/3TC+EFV | 16 | 40 | NA |
[back to top]
Time to Treatment Failure (NRTI Comparison)
Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier). (NCT00084136)
Timeframe: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 16 | 40 | NA |
,ZDV/3TC+EFV | 16 | 40 | NA |
[back to top]
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Intervention | participants (Number) |
---|
| Week 24: Number with RNA <400 c/mL (N=495; N=506) | Week 48: Number with RNA <400 c/mL (N=476; N=478) |
---|
ddI+FTC+ATV | 431 | 424 |
,ZDV/3TC+EFV | 459 | 437 |
[back to top]
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 96 using follow-up through study closure on May 31,2010
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 0 | 0 | NA |
,ZDV/3TC+EFV | 0 | 0 | 32 |
[back to top]
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression. (NCT00084136)
Timeframe: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 0 | 0 | 48 |
,ZDV/3TC+EFV | 0 | 16 | NA |
[back to top]
Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
Intervention | cells/mm^3 (Median) |
---|
| Change from screening to week 24 (N=490; N=498) | Change from screening to week 48 (N=480; N=485) | Change from screening to week 96 (N=458; N=471) |
---|
TDF/FTC+EFV | 120.5 | 159 | 226 |
,ZDV/3TC+EFV | 112.5 | 151.5 | 220.5 |
[back to top]
Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3). (NCT00084136)
Timeframe: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Intervention | cells/mm^3 (Median) |
---|
| Change from screening to week 24 (N=490; N=502) | Change from screening to week 48 (N=474; N=477) | Change from screening to week 96 (N= 188; N=188) |
---|
ddI+FTC+ATV | 146.5 | 187.0 | 256.0 |
,ZDV/3TC+EFV | 112.5 | 152.0 | 216.0 |
[back to top]
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored. (NCT00084136)
Timeframe: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
Intervention | participants (Number) |
---|
| Week 24: Number with RNA <400 c/mL (N=495; N=500) | Week 48: Number with RNA <400 c/mL (N=482; N=487) |
---|
TDF/FTC+EFV | 448 | 455 |
,ZDV/3TC+EFV | 459 | 442 |
[back to top]
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until study closed (May 31,2010)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
TDF/FTC+EFV | 18 | 36 | 201 |
,ZDV/3TC+EFV | 16 | 34 | 163 |
[back to top]
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir). (NCT00084136)
Timeframe: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
ddI+FTC+ATV | 7 | 18 | 76 |
,ZDV/3TC+EFV | 16 | 34 | NA |
[back to top]
Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until study closure (May 31, 2010)
Intervention | weeks (Number) |
---|
| 10th percentile | 25th percentile | 50th percentile |
---|
TDF/FTC+EFV | 4 | 32 | 224 |
,ZDV/3TC+EFV | 4 | 12 | 112 |
[back to top]
Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00084136)
Timeframe: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
Intervention | weeks (Number) |
---|
| 10th percentile | 25th percentile | 50th percentile |
---|
ddI+FTC+ATV | 4 | 32 | 144 |
,ZDV/3TC+EFV | 4 | 12 | 96 |
[back to top]
Percent of Participants Who Experienced Virologic Failure or Died
Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.
Intervention | Percent of participants (Number) |
---|
| week 48 percent of virologic failure or death | week 96 percent of virologic failure or death |
---|
NoNVP/LPV_r | 14 | 20 |
,NoNVP/NVP | 14 | 17 |
,NVP/LPV_r | 4 | 12 |
,NVP/NVP | 23 | 31 |
[back to top]
[back to top]
[back to top]
Number of Participants Who Experienced Virologic Failure or Died.
Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.
Intervention | participants (Number) |
---|
NVP/NVP | 32 |
NVP/LPV_r | 10 |
NoNVP/NVP | 42 |
NoNVP/LPV_r | 50 |
[back to top]
Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality
Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.
Intervention | participants (Number) |
---|
NVP/NVP | 20 |
NoNVP/NVP | 51 |
[back to top]
CD4 Count Change From Randomization
Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.
Intervention | cells/mm^3 (Median) |
---|
| Week 48 CD4 count change from randomization | Week 96 CD4 count change from randomization |
---|
NoNVP/LPV_r | 172 | 256 |
,NoNVP/NVP | 172 | 223 |
,NVP/LPV_r | 201 | 278 |
,NVP/NVP | 191 | 291 |
[back to top]
Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month
Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.
Intervention | percent of participants (Number) |
---|
| week 48 percent of full adherence in past month | week 96 percent of full adherence in past month |
---|
NoNVP/LPV_r | 86 | 87 |
,NoNVP/NVP | 90 | 93 |
,NVP/LPV_r | 88 | 95 |
,NVP/NVP | 89 | 94 |
[back to top]
Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry
5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
NVP/LPV_r | 60 | 84 | NA |
,NVP/NVP | 12 | 12 | 60 |
[back to top]
Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry
5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF. (NCT00089505)
Timeframe: Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile |
---|
NoNVP/LPV_r | 12 | 36 | 132 |
,NoNVP/NVP | 24 | 36 | NA |
[back to top]
Time to Treatment Initiation or Death
5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death (NCT00090779)
Timeframe: 5 years since randomization
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile | 50th percentile | 75th percentile |
---|
DT Arm | 13.9 | 20.9 | 43.7 | 97.3 | 157.7 |
,IT Arm | 36 | 36.9 | 67.1 | 96.4 | 163.3 |
[back to top]
Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile | 50th percentile | 75th percentile | 90th percentile |
---|
DT Arm | 6.9 | 12.3 | 26.3 | 60.0 | 96.0 | 96.0 |
,IT Arm | 6.3 | 13.0 | 36.4 | 72.0 | NA | NA |
[back to top]
Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm
(NCT00090779)
Timeframe: IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)
Intervention | Change in Log10 transformed CD4 Counts (Mean) |
---|
| IT arm (wk 60- wk 36) vs. DT arm (wk 24- wk 0) | IT arm (wk 72- wk 36) vs. DT arm (wk 36- wk 0) | IT arm (wk 84- wk 36) vs. DT arm (wk 48- wk 0) | IT arm (wk 96- wk 36) vs. DT arm (wk 60- wk 0) |
---|
DT Arm | -0.02 | -0.03 | -0.06 | -0.02 |
,IT Arm | -0.11 | -0.10 | -0.10 | -0.12 |
[back to top]
Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm
"The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D." (NCT00090779)
Timeframe: IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)
Intervention | rank (Median) |
---|
IT Arm | 26.0 |
DT Arm | 48.5 |
[back to top]
Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm
"The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the failures who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D." (NCT00090779)
Timeframe: At Weeks 72 and 76
Intervention | rank (Median) |
---|
IT Arm | 26.0 |
DT Arm | 49.3 |
[back to top]
Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 25th percentile | 50th percentile | 75th percentile | 90th percentile |
---|
DT Arm | 6.9 | 12.3 | 26.3 | 60.0 | 96.0 | 96.0 |
,IT Arm | 5.1 | 10.4 | 22.7 | 58.1 | NA | NA |
[back to top]
Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation
The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis. (NCT00090779)
Timeframe: 96 weeks since randomization
Intervention | Participants (Number) |
---|
IT Arm | 7 |
DT Arm | 23 |
[back to top]
Number of Participants in IT Arm Off Treatment Before 36 Weeks
The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm. (NCT00090779)
Timeframe: At Week 36
Intervention | participants (Number) |
---|
IT Arm | 8 |
[back to top]
Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.
(NCT00090779)
Timeframe: 96 weeks since randomization
Intervention | participants (Number) |
---|
IT Arm | 2 |
DT Arm | 8 |
[back to top]
Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping
"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.~10 participants who did not have resistance samples available were excluded from the primary endpoint analysis." (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment
Intervention | participants (Number) |
---|
7-day Lamivudine/Zidovudine (3TC/ZDV) | 1 |
21-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
7-day Lopinavir/Ritonavir (LPV/r) | 3 |
21-day Lopinavir/Ritonavir (LPV/r) | 1 |
[back to top]
Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment
Intervention | participants (Number) |
---|
7-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
21-day Lamivudine/Zidovudine (3TC/ZDV) | 1 |
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
7-day Lopinavir/Ritonavir (LPV/r) | 1 |
21-day Lopinavir/Ritonavir (LPV/r) | 0 |
[back to top]
Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.
For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed. (NCT00099632)
Timeframe: 2 and 6 weeks after completion of treatment
Intervention | participants (Number) |
---|
7-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
21-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
7-day Lopinavir/Ritonavir (LPV/r) | 0 |
21-day Lopinavir/Ritonavir (LPV/r) | 0 |
[back to top]
Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12
"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.~Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death" (NCT00099632)
Timeframe: From first day of study treatment to week 12
Intervention | participants (Number) |
---|
7-day Lamivudine/Zidovudine (3TC/ZDV) | 5 |
21-day Lamivudine/Zidovudine (3TC/ZDV) | 1 |
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
7-day Lopinavir/Ritonavir (LPV/r) | 2 |
21-day Lopinavir/Ritonavir (LPV/r) | 2 |
[back to top]
Number of Participants Who Discontinued Study Treatment Prematurely
participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively. (NCT00099632)
Timeframe: From first day of study treatment to last day of study treatment (up to 21 days)
Intervention | participants (Number) |
---|
7-day Lamivudine/Zidovudine (3TC/ZDV) | 0 |
21-day Lamivudine/Zidovudine (3TC/ZDV) | 2 |
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0 |
7-day Lopinavir/Ritonavir (LPV/r) | 0 |
21-day Lopinavir/Ritonavir (LPV/r) | 5 |
[back to top]
Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters
Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported. (NCT00105079)
Timeframe: baseline and all study visits (Up to Week 52)
Intervention | participants (Number) |
---|
Saquinavir/Ritonavir | 0 |
Lopinavir/Ritonavir | 0 |
[back to top]
Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count
Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) - (CD4+ count at baseline). (NCT00105079)
Timeframe: Baseline to Week 48
Intervention | cells/mm^3 (Median) |
---|
| Baseline (n=166,169) | Week 48 (n=122,131) | Change from Baseline to Week 48 (n=121,130) |
---|
Lopinavir/Ritonavir | 142.0 | 348.0 | 204.0 |
,Saquinavir/Ritonavir | 141.5 | 319.0 | 178.0 |
[back to top]
Change From Baseline in HIV-1 RNA Viral Load
Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) - Log10 (HIV-1 RNA at baseline) (NCT00105079)
Timeframe: Baseline to Week 48
Intervention | copies/mL (Mean) |
---|
| Baseline | Week 48 (n=126,133) | Change from Baseline to Week 48 (n=126,133) |
---|
Lopinavir/Ritonavir | 5.17 | 1.83 | -3.36 |
,Saquinavir/Ritonavir | 5.20 | 1.80 | -3.39 |
[back to top]
Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL
"The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported." (NCT00105079)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| Patients with <50 Copies/mL | Patients with <400 Copies/mL |
---|
Lopinavir/Ritonavir | 108 | 127 |
,Saquinavir/Ritonavir | 108 | 121 |
[back to top]
Number of Participants Assessed for Adverse Events (AEs)
Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS. (NCT00105079)
Timeframe: reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)
Intervention | participants (Number) |
---|
Saquinavir/Ritonavir | 163 |
Lopinavir/Ritonavir | 168 |
[back to top]
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
"The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported." (NCT00105079)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| Pts. with HIV-1 RNA Viral Load <50 copies/mL - YES | Pts. with HIV-1 RNA Viral Load <50 copies/mL - NO |
---|
Lopinavir/Ritonavir | 108 | 62 |
,Saquinavir/Ritonavir | 108 | 59 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 15 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 144
The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 63.1 |
CBV+EFV | 51.6 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96)
The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 87 |
All Atripla (From Atripla Baseline) | 85 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA < 400 c/mL at Week 48.
The percentage of participants with plasma HIV-1 RNA < 400 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 400 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 80.4 |
CBV+EFV | 69.3 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 144
The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 144. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 60.8 |
CBV+EFV | 50.4 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 87 |
[back to top]
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 48
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 9 |
CBV+EFV | 16 |
[back to top]
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 400 c/mL) at Week 96
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 9 |
CBV+EFV | 17 |
[back to top]
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 48
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Baseline to 48 Weeks
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 16 |
CBV+EFV | 24 |
[back to top]
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) at Week 144
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 11 |
CBV+EFV | 17 |
[back to top]
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 400 c/mL) Through Week 240 (Atripla Week 96)
Participants who achieved confirmed HIV-1 RNA < 400 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 11 |
All Atripla (From Atripla Baseline) | 2 |
[back to top]
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) at Week 144
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 21 |
CBV+EFV | 25 |
[back to top]
Percentage of Participants With Pure Virological Failure (HIV-1 RNA < 50 c/mL) Through Week 240 (Atripla Week 96)
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 22 |
All Atripla (From Atripla Baseline) | 4 |
[back to top]
Quality of Life (SF-12v2 Health Survey: Mental Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey MCS. The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the MCS. PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and a SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Composite Score (Mean) |
---|
All Atripla | 0.9 |
[back to top]
Quality of Life (SF-12v2 Health Survey: Physical Component Summary) Change From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
The change from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) in the SF-12v2 Health Survey: Physical Component Summary (PCS). The SF-12v2 includes 8 concepts commonly represented in health surveys: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. Results are expressed in terms of 2 composite scores: the PCS and the Mental Component Summary (MCS). PCS and MCS values can range from 0 to 100 and are designed to have a mean value of 50 and SD of 10 (in the general population). (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Composite Score (Mean) |
---|
All Atripla | 0.0 |
[back to top]
Treatment Satisfaction Questionnaire (Bothered With the Side Effects of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: How bothered are you with the side effects of your current treatment regimen? Possible responses were on a 4-category scale: does not bother me; bothers me a little bit; bothers me a lot; and bothers me terribly. For the evaluation of the change in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into does not bother me and bothers me (bothers me included bothers me a little bit; bothers me a lot; bothers me terribly)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Bothers me (W 144 and W 240) | Does not bother me (W 144 and W 240) | Bothers me (W 144); does not bother me (W 240) | Does not bother me (W 144); bothers me (W 240) |
---|
All Atripla | 41 | 126 | 31 | 28 |
[back to top]
Treatment Satisfaction Questionnaire (General Satisfaction With Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 180 | 10 | 9 | 23 |
[back to top]
Treatment Satisfaction Questionnaire (Satisfaction With Convenience and Simplicity of Current Treatment Regimen): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with the convenience and simplicity of your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 182 | 6 | 8 | 29 |
[back to top]
Treatment Satisfaction Questionnaire (Satisfaction With Current Treatment Regimen to Control HIV): Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with the ability of your current treatment regimen to control your HIV infection? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 192 | 8 | 9 | 17 |
[back to top]
Treatment Satisfaction Questionnaire (Satisfaction With Tolerability of Current Treatment Regimen) Change From Week 144 to Week 240 in the Category Shift From Atripla Baseline.
"Participants were asked: In general, how satisfied are you with your ability to tolerate your current treatment regimen? Possible responses were on a 4-category scale: very satisfied; somewhat satisfied; somewhat dissatisfied; and very dissatisfied. For the evaluation of changes in treatment satisfaction from Week 144 (Atripla baseline) to Week 240 (Atripla Week 96) responses were dichotomized into very satisfied and not very satisfied (not very satisfied included very dissatisfied; somewhat dissatisfied; and somewhat satisfied)." (NCT00112047)
Timeframe: Week 144 ([W 144]; Atripla baseline) to Week 240 ([W 240]; Atripla Week 96)
Intervention | Participants (Number) |
---|
| Very satisfied (W 144 and W 240) | Not very satisfied (W 144 and W 240) | Very satisfied (W 144); not very satisfied (W 240) | Not very satisfied (W 144); very satisfied (W 240) |
---|
All Atripla | 166 | 21 | 13 | 26 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96)
The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 240. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 84 |
All Atripla (From Atripla Baseline) | 82 |
[back to top]
Percentage of Participants With Pure Virologic Failure (HIV-1 RNA < 50 c/mL) at Week 96
Participants who achieved confirmed HIV-1 RNA < 50 c/mL but had not experienced a confirmed relapse were considered censored at the last HIV-1 RNA collection date. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 20 |
CBV+EFV | 23 |
[back to top]
Change From Baseline in CD4 Cell Count (Cells/mm^3) at Week 240 (Atripla Week 96)
Change from baseline to Week 240 (Atripla Week 96) in CD4 cell count = Week 240 (Atripla Week 96) CD4 cell count value minus baseline CD4 cell count value (NCT00112047)
Timeframe: Study/Atripla baseline to Week 240 (Atripla Week 96)
Intervention | CD4 Cell count (Cells/mm^3) (Mean) |
---|
EFV+FTC+TDF/Atripla (From Study Baseline) | 346 |
All Atripla (From Atripla Baseline) | 42 |
[back to top]
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 144
Change from study baseline to Week 144 in CD4 cell count = Week 144 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 144
Intervention | CD4 Cell Count (cells/mm^3) (Mean) |
---|
EFV+FTC+TDF | 312 |
CBV+EFV | 271 |
[back to top]
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 48
Change from study baseline to Week 48 in CD4 cell count = Week 48 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Study baseline to Week 48
Intervention | CD4 Cell Count (cells/mm^3) (Mean) |
---|
EFV+FTC+TDF | 190 |
CBV+EFV | 158 |
[back to top]
Change From Study Baseline in CD4 Cell Count (Cells/mm^3) at Week 96
Change from study baseline to Week 96 in CD4 cell count = Week 96 CD4 cell count value minus study baseline CD4 cell count value (NCT00112047)
Timeframe: Baseline to Week 96
Intervention | CD4 Cell Count (cells/mm^3) (Mean) |
---|
EFV+FTC+TDF | 270 |
CBV+EFV | 237 |
[back to top]
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 144
Change from study baseline to Week 144 in HIV-1 RNA in log10 scale (Week 144 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 144
Intervention | Log10 c/mL (Mean) |
---|
EFV+FTC+TDF | -3.32 |
CBV+EFV | -3.30 |
[back to top]
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 48
Change from study baseline to Week 48 in HIV-1 RNA in log10 scale (Week 48 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 48
Intervention | Log10 c/mL (Mean) |
---|
EFV+FTC+TDF | -3.31 |
CBV+EFV | -3.26 |
[back to top]
Change From Study Baseline in HIV-1 RNA (Log10 c/mL) at Week 96
Change from study baseline to Week 96 in HIV-1 RNA in log10 scale (Week 96 HIV-1 RNA value in log10 scale minus study baseline HIV-1 RNA value in log10 scale). (NCT00112047)
Timeframe: Study baseline to Week 96
Intervention | Log10 c/mL (Mean) |
---|
EFV+FTC+TDF | -3.30 |
CBV+EFV | -3.25 |
[back to top]
Change in Limb Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in limb fat = Week 240 (Atripla Week 96) limb fat value minus Week 144 (Atripla Baseline) limb fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | limb fat (kg) (Mean) |
---|
All Atripla | 0.12 |
[back to top]
Change in Limb Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in limb fat = Week 144 limb fat value minus Week 48 limb fat value (NCT00112047)
Timeframe: Week 48 to Week 144
Intervention | limb fat (kg) (Mean) |
---|
EFV+FTC+TDF | 1.13 |
CBV+EFV | -1.09 |
[back to top]
Change in Limb Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in limb fat = Week 96 limb fat value minus Week 48 limb fat value. (NCT00112047)
Timeframe: Week 48 to Week 96
Intervention | limb fat (kg) (Mean) |
---|
EFV+FTC+TDF | 0.74 |
CBV+EFV | -0.77 |
[back to top]
Change in Total Body Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in total body fat = Week 240 (Atripla Week 96) total body fat value minus Week 144 (Atripla Baseline) total body fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | total body fat (kg) (Mean) |
---|
All Atripla | 0.37 |
[back to top]
Change in Total Body Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in total body fat = Week 144 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: Week 48 to Week 144
Intervention | total body fat (kg) (Mean) |
---|
EFV+FTC+TDF | 2.47 |
CBV+EFV | -1.18 |
[back to top]
Change in Total Body Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in total body fat = Week 96 total body fat value minus Week 48 total body fat value (NCT00112047)
Timeframe: 48 weeks to 96 weeks
Intervention | total body fat (kg) (Mean) |
---|
EFV+FTC+TDF | 1.69 |
CBV+EFV | -0.82 |
[back to top]
Change in Trunk Fat (kg) From Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Change from Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96) in trunk fat = Week 240 (Atripla Week 96) trunk fat value minus Week 144 (Atripla Baseline) trunk fat value (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | trunk fat (kg) (Mean) |
---|
All Atripla | 0.27 |
[back to top]
Change in Trunk Fat (kg) From Week 48 to Week 144
Change from Week 48 to Week 144 in trunk fat = Week 144 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 144
Intervention | trunk fat (kg) (Mean) |
---|
EFV+FTC+TDF | 1.30 |
CBV+EFV | -0.10 |
[back to top]
Change in Trunk Fat (kg) From Week 48 to Week 96
Change from Week 48 to Week 96 in trunk fat = Week 96 trunk fat value minus Week 48 trunk fat value (NCT00112047)
Timeframe: Week 48 to Week 96
Intervention | trunk fat (kg) (Mean) |
---|
EFV+FTC+TDF | 0.94 |
CBV+EFV | -0.04 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 144 visit (i.e., the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV-1 RNA levels < 400 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: 144 weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 70.9 |
CBV+EFV | 58.1 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time-to-Loss-of Virologic Response [TLOVR] Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 48 visit (ie, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: 48 weeks
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 84.4 |
CBV+EFV | 72.8 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 400 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 400 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 400 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 400 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 400 c/mL after achievement of confirmed HIV RNA levels < 400 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: 96 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 74.6 |
CBV+EFV | 61.9 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 144 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL (c/mL) had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug, except nevirapine in place of EFV, prior to Week 144 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 144 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 144 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV-1 RNA levels < 50 c/mL prior to Week 144 visit. (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
EFV+FTC+TDF | 64.3 |
CBV+EFV | 56.3 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 240 (Atripla Week 96) Defined by the FDA TLOVR Algorithm
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 240 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 240 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 240 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 240 visit. (NCT00112047)
Timeframe: Week 144 (Atripla baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 85 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 48 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 48 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 48 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 48 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 48 visit. (NCT00112047)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 79.5 |
CBV+EFV | 70.4 |
[back to top]
Percentage of Participants With Confirmed Plasma HIV-1 RNA < 50 c/mL at Week 96 (Defined by FDA TLOVR Algorithm)
Participants who achieved/maintained confirmed HIV-1 RNA < 50 c/mL had to satisfy the following criteria: 1) not experienced death, permanent study drug discontinuation, or addition of new antiretroviral drug except nevirapine in place of EFV prior to Week 96 visit; 2) achieved confirmed HIV-1 RNA < 50 c/mL on 2 consecutive visits prior to Week 96 visit (that is, the first of the 2 consecutive HIV-1 RNA < 50 c/mL occurred prior to the Week 96 visit; 3) not had confirmed HIV-1 RNA > 50 c/mL after achievement of confirmed HIV RNA levels < 50 c/mL prior to Week 96 visit. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 67.2 |
CBV+EFV | 60.9 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 c/mL at Week 48
The percentage of participants with plasma HIV-1 RNA < 50 c/mL at Week 48. Participants with missing observations/changes in ART were considered to have HIV-1 RNA ≥ 50 c/mL (i.e., ITT missing or switch=failure analysis). (NCT00112047)
Timeframe: 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 74.5 |
CBV+EFV | 66.9 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 144
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 28 |
CBV+EFV | 41 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 48
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 19 |
CBV+EFV | 30 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) at Week 96
TLOVR for participants with confirmed virologic response (2 consecutive HIV-1 RNA < 400 c/mL) prior to study drug discontinuation, was the time to the earliest of premature study regimen discontinuation, or confirmed HIV-1 RNA > 400 c/mL (2 consecutive HIV-1 RNA ≥ 400 c/mL, or the last HIV-1 RNA ≥ 400 c/mL followed by premature study regimen discontinuation due to loss to follow-up). Participants who did not achieve confirmed virologic response before premature study regimen discontinuation or last HIV-1 RNA, were assumed to have lost virologic response on Study Day 1. (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 25 |
CBV+EFV | 37 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 400 c/mL) From Week 144 (Atripla Baseline) Through Week 240 (Atripla Week 96)
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 400 c/mL or last HIV-1 RNA ≥ 400 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 400 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144 (Atripla Baseline) to Week 240 (Atripla Week 96)
Intervention | Percentage of Participants (Number) |
---|
All Atripla | 13 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 144
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 144
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 34 |
CBV+EFV | 43 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 48
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Baseline to 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 23 |
CBV+EFV | 32 |
[back to top]
Percentage of Participants With Loss of Virologic Response (HIV-1 RNA < 50 c/mL) at Week 96
"TLOVR for participants who achieved a confirmed virologic response was the time to the earliest of: premature study regimen discontinuation or the first of 2 consecutive HIV-1 RNA ≥ 50 c/mL or last HIV-1 RNA ≥ 50 c/mL followed by loss to follow-up. If the time to HIV-1 RNA ≥ 50 c/mL was immediately preceded by missing scheduled visits then the time of virologic failure was replaced by the first such missing visit. Participants who had not achieved a confirmed virologic response before regimen discontinuation were considered non-responders on Study Day 1." (NCT00112047)
Timeframe: Week 96
Intervention | Percentage of Participants (Number) |
---|
EFV+FTC+TDF | 32 |
CBV+EFV | 38 |
[back to top]
Number of Participants With Treatment Modification
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Intervention | participants (Number) |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 152 |
EFV, Placebo FTC/TDF, and ABC/3TC | 239 |
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 138 |
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 216 |
[back to top]
Number of Participants With Regimen Failure
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Intervention | participants (Number) |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 162 |
EFV, Placebo FTC/TDF, and ABC/3TC | 246 |
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 157 |
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 233 |
[back to top]
Amount of Study Follow-up
Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks
Intervention | Weeks (Median) |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 141.4 |
EFV, Placebo FTC/TDF, and ABC/3TC | 133.3 |
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 141.6 |
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 137.3 |
[back to top]
Cumulative Probability of Not Experiencing Treatment Modification
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 80 | 73 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 67 | 56 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 86 | 77 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 73 | 62 |
[back to top]
Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Intervention | Weeks (Number) |
---|
| 5th percentile time to regimen failure | 10th percentile time to regimen failure | 25th percentile time to regimen failure |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 4 | 16 | 72 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 4 | 4 | 24 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 4 | 16 | 84 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 4 | 4 | 36 |
[back to top]
Time From Treatment Dispensation to a Grade 3/4 Safety Event
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00118898)
Timeframe: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.
Intervention | Weeks (Number) |
---|
| 5th percentile time to a grade 3/4 safety event | 10th percentile time to a grade 3/4 safety event | 25th percentile time to a grade 3/4 safety event |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 2.6 | 7.9 | 59.3 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 1.3 | 2.0 | 16.0 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 3.0 | 8.1 | 81.4 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 1.3 | 3.9 | 44.4 |
[back to top]
Time From Randomization to Virologic Failure
Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Intervention | Weeks (Number) |
---|
| 5th percentile time to virologic failure | 10th percentile time to virologic failure |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 36 | 96 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 24 | 36 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 24 | 84 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 24 | 36 |
[back to top]
Time From Treatment Dispensation to Treatment Modification
Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Intervention | Weeks (Number) |
---|
| 5th percentile time to treatment modification | 10th percentile time to treatment modification | 25th percentile time to treatment modification |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 3.4 | 15.0 | 83.7 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 1.4 | 2.1 | 27.4 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 7.9 | 24.9 | 108.9 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 1.6 | 5.0 | 43.6 |
[back to top]
The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
(NCT00118898)
Timeframe: At Weeks 48 and 96
Intervention | Participants (Number) |
---|
| Number of Participants with RNA data at Week 48 | Number with HIV-1 RNA <50 copies/ml at Week 48 | Number of Participants with RNA data at Week 96 | Number with HIV-1 RNA <50 copies/ml at Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 415 | 372 | 379 | 345 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 400 | 346 | 361 | 328 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 416 | 348 | 384 | 345 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 411 | 322 | 374 | 317 |
[back to top]
Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL
(NCT00118898)
Timeframe: At Weeks 48 and 96
Intervention | Participants (Number) |
---|
| Number of Participants with RNA data at Week 48 | Number with HIV-1 RNA <200 copies/ml at Week 48 | Number of Participants with RNA data at Week 96 | Number with HIV-1 RNA <200 copies/ml at Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 415 | 398 | 379 | 362 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 400 | 377 | 361 | 342 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 416 | 391 | 384 | 368 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 411 | 372 | 374 | 346 |
[back to top]
Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: At week 48 and 96
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 78 | 70 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 64 | 58 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 79 | 73 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 73 | 66 |
[back to top]
Change in Fasting Triglyceride Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
Intervention | mg/dL (Median) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 10 | 9 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 15 | 14 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 14 | 11 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 24 | 33 |
[back to top]
Change in Fasting Total Cholesterol Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
Intervention | mg/dL (Median) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 22 | 23 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 35 | 33 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 11 | 14 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 30 | 25 |
[back to top]
Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
Intervention | mg/dL (Median) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 14 | 13.5 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 23 | 18 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 8 | 10 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 20 | 18 |
[back to top]
Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline
Only fasting results are included. The protocol did not require that samples be collected fasting. (NCT00118898)
Timeframe: At Weeks 48 and 96
Intervention | mg/dL (Median) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 8 | 9 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 10 | 11 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 5 | 4 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 8 | 7 |
[back to top]
Number of Participants With a Grade 3/4 Safety Event
Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. (NCT00118898)
Timeframe: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks
Intervention | participants (Number) |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 145 |
EFV, Placebo FTC/TDF, and ABC/3TC | 182 |
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 137 |
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 156 |
[back to top]
Change in CD4 Count (Cells/mm3) From Baseline
Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). (NCT00118898)
Timeframe: At Weeks 48 and 96
Intervention | Cells/mm3 (Median) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 163 | 220.5 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 188 | 250.5 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 175 | 251.5 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 177.5 | 250.3 |
[back to top]
Number of Participants With Virologic Failure and Emergence of Major Resistance
Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. (NCT00118898)
Timeframe: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Intervention | participants (Number) |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 27 |
EFV, Placebo FTC/TDF, and ABC/3TC | 41 |
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 5 |
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 12 |
[back to top]
Number of Participants With Virologic Failure
Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details
Intervention | participants (Number) |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 57 |
EFV, Placebo FTC/TDF, and ABC/3TC | 72 |
RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 57 |
RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 83 |
[back to top]
[back to top]
Cumulative Probability of Not Experiencing Virologic Failure
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. (NCT00118898)
Timeframe: At week 48 and 96
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 94 | 90 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 88 | 85 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 92 | 89 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 88 | 83 |
[back to top]
Cumulative Probability of Not Experiencing Regimen Failure
Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. (NCT00118898)
Timeframe: At week 48 and 96
Intervention | percentage of participants (Number) |
---|
| Week 48 | Week 96 |
---|
EFV, FTC/TDF, and Placebo ABC/3TC | 79 | 70 |
,EFV, Placebo FTC/TDF, and ABC/3TC | 64 | 54 |
,RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | 80 | 73 |
,RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | 66 | 57 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 67.5 |
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 67.2 |
[back to top]
[back to top]
[back to top]
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)
Intervention | participants (Number) |
---|
| Resistance NRTI class (M184V, M/V,M/I,A/V,I,M/I/V) | Reduced pheno susceptibility to lamivudine/M184V | Reduced phen susceptibility to lamivudine/M184M/V | Reduced pheno susceptibility to lamivudine/M184M/I | Reduced pheno susceptibility to lamivudine/M184A/V | Reduced pheno susceptibility to lamivudine/M184I | Reduced pheno suscept. to lamivudine/M184M/I/V | Reduced pheno suscept. to emtricitabine/M184V | Reduced pheno suscept. to emtricitabine/M184M/V | Reduced pheno suscept. to emtricitabine/M184M/I | Reduced pheno suscept. to emtricitabine/M184A/V | Reduced pheno suscept. to emtricitabine/M184I | Reduced pheno suscept. to emtricitabine/M184M/I/V |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 11 | 4 | 3 | 0 | 0 | 0 | 0 | 4 | 3 | 0 | 0 | 0 | 0 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 17 | 9 | 0 | 1 | 1 | 1 | 1 | 9 | 0 | 1 | 1 | 1 | 1 |
[back to top]
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. (NCT00244712)
Timeframe: Baseline and time of virologic failure (up to Week 96)
Intervention | participants (Number) |
---|
| No. with paired genotypes at baseline and wk 96 | Participants with treatment-emergent mutations | NRTI-associated mutations | NNRTI-associated mutations | PI-associated mutations |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 45 | 18 | 11 | 4 | 11 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 41 | 22 | 17 | 3 | 7 |
[back to top]
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions. (NCT00244712)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Protocol-defined virologic failure | Fail to confirm HIV-1 RNA <200 copies/mL by wk 24 | Confirmed HIV-1 RNA rebound to >= 200 copies/mL | Suspected HIV-1 RNA rebound to >= 200 copies/mL |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 49 | 21 | 28 | 12 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 48 | 24 | 24 | 11 |
[back to top]
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated. (NCT00244712)
Timeframe: Baseline through 96 weeks
Intervention | participants (Number) |
---|
| Participants (Par.) with suspected ABC HSR | Mild or Grade 1 | Moderate or Grade 2 | Severe or Grade 3 | Not Applicable | Par. with proximal renal tubule dysfunction |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 14 | 1 | 8 | 4 | 1 | 0 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 3 | 0 | 2 | 1 | 0 | 5 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | MD=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | MD=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 71 | 67 | 89 | 68 | 63 | 57 | 89 | 59 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 69 | 62 | 88 | 62 | 58 | 52 | 94 | 54 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 63 | 57 | 78 | 59 | 56 | 46 | 84 | 54 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 65 | 60 | 86 | 62 | 58 | 51 | 88 | 55 |
[back to top]
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 76 | 72 | 94 | 72 | 65 | 60 | 92 | 61 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 71 | 66 | 91 | 65 | 60 | 55 | 97 | 56 |
[back to top]
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL. (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 75 | 70 | 94 | 71 | 63 | 56 | 93 | 59 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 71 | 67 | 94 | 68 | 63 | 58 | 96 | 58 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
| TLOVR | Obs | M/D=F |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 62.6 | 84.3 | 64.3 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 61.1 | 86.8 | 62.3 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included | TLOVR | Obs | M/D=F |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 59.9 | 52.1 | 86.9 | 56.4 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 58.0 | 51.0 | 91.3 | 54.5 |
[back to top]
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL). (NCT00244712)
Timeframe: Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| M=F, Switch Included, Week 48 | TLOVR, Week 48 | Obs, Week 48 | M/D=F, Week 48 | M=F, Switch Included, Week 96 | TLOVR, Week 96 | Obs, Week 96 | M/D=F, Week 96 |
---|
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) | 75.2 | 70.9 | 93.8 | 71.4 | 63.9 | 58.4 | 92.8 | 60.1 |
,Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV | 71.3 | 66.4 | 92.2 | 66.2 | 61.2 | 56.3 | 96.3 | 56.9 |
[back to top]
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 48
MOS-HIV is developed to assess a participant's health and functional status associated with HIV infection. The questionnaire is applied to participants with adequate linguistic skills and consists of 35 items. The questionnaire derives an overall health score and 10 subscale scores (health transitions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy/fatigue, health distress and quality of life).The subscale and summary scores range from 0-100 with a higher score indicating better health. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Units on Scale (Mean) |
---|
| Physical Health Summary (296, 287) | Mental Health Summary (296, 287) | Overall Health Perception Subscale (305, 297) | Physical Function Subscale (303, 298) | Role Function Subscale (307, 298) | Social Function Subscale (308, 295) | Cognitive Function Subscale (307, 300) | Pain Subscale (308, 297) | Mental Health Subscale (306, 300) | Energy/Fatigue Subscale (304, 300) | Health Distress Subscale (304, 300) | Quality of Life Subscale (308, 300) | Health Transition Subscale (308, 300) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 3.8 | 6.0 | 15.6 | 5.8 | 8.5 | 9.2 | 4.8 | 8.3 | 8.3 | 8.4 | 14.3 | 12.9 | 11.0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 3.3 | 5.6 | 13.7 | 5.3 | 8.1 | 7.4 | 5.6 | 8.0 | 8.7 | 7.9 | 15.0 | 8.4 | 8.8 |
[back to top]
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Survey - Human Immunodeficiency Virus (MOS-HIV) at Week 24
Medical Outcomes Study HIV Health Survey (MOS-HIV) is developed to assess a patient's health and functional status associated with HIV infection. The MOS-HIV questionnaire is applied to participants with adequate linguistic skills. The subscale and summary scores range from 0-100 with a higher score indicating better health. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 24.
Intervention | Units on Scale (Mean) |
---|
| Physical Health Summary (317, 314) | Mental Health Summary (317, 314) | Overall Health Perception Subscale (325, 320) | Physical Function Subscale (324, 325) | Role Function Subscale (325, 325) | Social Function Subscale (327, 322) | Cognitive Function Subscale (326, 324) | Pain Subscale (327, 325) | Mental Health Subscale (325, 326) | Energy/Fatigue Subscale (323, 326) | Health Distress Subscale (323, 326) | Quality of Life Subscale (327, 326) | Health Transition Subscale (327, 326) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4.1 | 5.3 | 15.2 | 7.6 | 10.6 | 8.5 | 5.6 | 7.4 | 6.4 | 7.1 | 14.4 | 9.9 | 13.1 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 3.3 | 4.8 | 13.0 | 5.0 | 6.5 | 7.1 | 3.0 | 8.6 | 7.4 | 7.5 | 13.9 | 7.1 | 10.7 |
[back to top]
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 12 (IBS-QoL)
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction. (NCT00272779)
Timeframe: IBS-QoL is administered at baseline (Day 1) and Week 12.
Intervention | Units on Scale (Mean) |
---|
| Overall (301. 310) | Dysphoria (308, 319) | Interference with activity (310, 320) | Body image (316, 321) | Health worry (312, 320) | Food avoidance (316, 322) | Social reaction (311, 316) | Sexual (317, 321) | Relationships (313, 320) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4.6 | 4.7 | 5.1 | 2.1 | 7.9 | 5.6 | 3.3 | 4.7 | 3.5 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0.2 | 1.2 | -0.4 | -0.1 | 3.6 | -0.6 | -0.4 | -0.4 | 0.0 |
[back to top]
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Asssociated With RS11030679
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | pg/mL (Mean) |
---|
| Fasting TNF-alpha: RS11030679 WT | Fasting TNF-alpha: RS11030679 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 7.58 | 0.02 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -0.13 | 1.27 |
[back to top]
Mean Change From Baseline in Fasting Tumor Necrosis Factor (TNF)-Alpha Associated With IL6_5309
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | pg/mL (Mean) |
---|
| Fasting TNF-alpha: IL6_5309 WT | Fasting TNF-alpha: IL6_5309 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -1.19 | 6.01 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -2.68 | 1.41 |
[back to top]
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_734
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | mg/dL (Mean) |
---|
| Fasting Triglycerides: RETN_734 WT | Fasting Triglycerides: RETN_734 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 23.35 | 21.16 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 75.12 | 155.28 |
[back to top]
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_598
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | mg/dL (Mean) |
---|
| Fasting Triglycerides: RETN_598 WT | Fasting Triglycerides: RETN_598 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 20.23 | 25.78 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 61.66 | 123.28 |
[back to top]
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_2265
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | mg/dL (Mean) |
---|
| Fasting Triglycerides: RETN_2265 WT | Fasting Triglycerides: RETN_2265 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 19.61 | 28.70 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 65.83 | 148.95 |
[back to top]
Mean Change From Baseline in Fasting Triglycerides Associated With RETN_097
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | mg/dL (Mean) |
---|
| Fasting Triglycerides: RETN_097 WT | Fasting Triglycerides: RETN_097 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 21.41 | 27.21 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 68.06 | 157.87 |
[back to top]
Mean Change From Baseline in Fasting Triglycerides Associated With APOE_C130R
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | mg/dL (Mean) |
---|
| Fasting Triglycerides: APOE_C130R WT | Fasting Triglycerides: APOE_C130R MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 23.27 | 13.92 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 70.71 | 131.56 |
[back to top]
Mean Change From Baseline in Fasting Plasminogen Activator Inhibitor (PAI)-1 Associated With APOE_R176C
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | ng/dL (Mean) |
---|
| Fasting PAI-1: APOE_R176C WT |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 5.98 | -117.27 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 7.30 | -5.94 |
[back to top]
Mean Change From Baseline in Fasting Non-High Density Lipoprotein (HDL) Cholesterol Associated With RETN_097
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted (adj) p-values were calculated for each phenotype-genotype pair. (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | mg/dL (Mean) |
---|
| Fasting Non-HDL Cholesterol: RETN_097 WT | Fasting Non-HDL Cholesterol: RETN_097 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 12.50 | 13.23 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 26.98 | 52.28 |
[back to top]
Mean Change From Baseline (BL) in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 4 (IBS-QoL)
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction. (NCT00272779)
Timeframe: IBS-QoL is administered at baseline (Day 1) and Week 4.
Intervention | Units on Scale (Mean) |
---|
| Overall (306, 316) | Dysphoria (317, 325) | Interference with activity (319, 327) | Body image (321, 329) | Health worry (319, 330) | Food avoidance (319, 329) | Social reaction (316, 327) | Sexual (320, 329) | Relationships (321, 328) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 3.2 | 3.3 | 3.1 | 1.6 | 6.0 | 4.0 | 1.9 | 3.7 | 1.2 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -0.7 | -0.1 | -1.9 | -1.3 | 2.0 | -1.7 | -0.8 | -0.1 | -0.6 |
[back to top]
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Tmax was derived from the plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | Hr (Median) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 3.00 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 4.00 |
[back to top]
Terminal Elimination Half-life (T-half) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
T-half was derived from the plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | Hr (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 10.31 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 13.89 |
[back to top]
Reduction of log10 HIV RNA Levels From Baseline to Week 48
Changes from baseline in log10 HIV RNA levels were calculated. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | c/mL (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -3.09 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -3.13 |
[back to top]
Reduction of log10 HIV RNA Levels From Baseline at Week 96
Changes from baseline in log10 HIV RNA levels were calculated. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | c/mL (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -3.21 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -3.19 |
[back to top]
Protein Binding Adjusted Effective Concentration (EC-90) of ATV and LPV When Dosed With RTV at Week 4
EC90/50=concentration of drug inducing 90%/50% of its maximal response. Protein binding adjusted EC90 for ATV and LPV were derived from phenotypically measured individual EC50 values at baseline using the following formula: Protein binding adjusted EC90 (ng/mL) = scale factor × molecular weight of the free base × EC50 micrometer(μM)/ unbound fraction (fu). Scale factor relates EC50 to EC90 (value of 3 and 2 for ATV and LPV, respectively); fu: estimated unbound fraction of ATV and LPV in vivo (0.14 and 0.02 for ATV and LPV respectively). (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 19.01 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 162.7 |
[back to top]
Percentage of Participants With Lipoatrophy at Week 96
Lipoatrophy, redistribution of body fat was defined as >= 20% decrease in limb fat. The percentage of participants with lipoatrophy from baseline was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | percentage of participants (Number) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 5 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 7 |
[back to top]
Number of Participants With Human-immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) < 50 Copies (c)/mL at Week 48
HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Participants (Number) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 343 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 338 |
[back to top]
Number of Participants With HIV RNA < 50 c/mL) at Week 96
HIV RNA < 50 c/mL is the most stringent measure of viral suppression (lowest threshold of assay) and indicates that a participant has responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Participants (Number) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 327 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 302 |
[back to top]
Number of Participants With HIV RNA < 400 c/mL) at Week 96
HIV RNA <400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant has responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Participants (Number) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 350 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 330 |
[back to top]
Number of Participants With HIV RNA < 400 c/mL at Week 48
HIV RNA < 400 c/mL is a less stringent measure of viral suppression (highest threshold of assay) and indicates that a participant responded to treatment. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Participants (Number) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 377 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 365 |
[back to top]
Number of Participants With Confirmed Plasma HIV RNA < 400 c/mL at Week 48 (Defined by the Food and Drug Administration [FDA] Time to Loss of Virologic Response [TLOVR] Algorithm)
TLOVR defines responders at Week 48 as participants with confirmed HIV RNA <400 c/mL through Week 48 without intervening virologic rebound or treatment discontinuation. Virologic rebound is defined as confirmed on-treatment HIV RNA <400 c/mL or last on-treatment HIV RNA <400 c/mL followed by discontinuation. Participants are considered failures in this analysis if they experienced virologic rebound at or before Week 48, discontinued before Week 48, never responded by Week 48, never received study therapy or had missing HIV RNA at Week 48 and beyond. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Participants (Number) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 377 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 363 |
[back to top]
Number of Participants Who Adhered to Regimen as Measured by Multicenter AIDS Cohort Study Adherence Questionnaire (MACS) at Week 48
The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Adherence to regimen was defined as taking 100% of medicine (all doses and numbers of pills as prescribed for each medicine). This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance. (NCT00272779)
Timeframe: Week 48
Intervention | Participants (Number) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 330 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 316 |
[back to top]
Minimum Plasma Concentration (Cmin) of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
Cmin was derived from the plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 526.4 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 5944 |
[back to top]
Mean Changes in Fasting Insulin at Week 96
Mean change from baseline in fasting insulin at Week 96. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.
Intervention | µU/mL (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0.1 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -0.8 |
[back to top]
Mean Changes in Fasting Glucose at Week 96
Mean change from baseline in fasting glucose at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | mg/dL (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4.0 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 1.0 |
[back to top]
Mean Changes From Baseline in Body Weight at Week 96
Mean change in body weight from baseline was determined. (NCT00272779)
Timeframe: Physical examination was performed at Baseline (Day 1) and Weeks 48 and 96.
Intervention | kg (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 6 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 3 |
[back to top]
Mean Change in Weight From Baseline at Week 48
Mean change in body weight from baseline was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | kg (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4.0 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 2.0 |
[back to top]
Mean Change in Fasting Insulin at Week 48
Mean change from baseline in fasting insulin at Week 48. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.
Intervention | micro units (µU)/mL (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 2.5 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0.2 |
[back to top]
Mean Change in Fasting Glucose at Week 48
Mean change from baseline in fasting glucose at Week 48. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.
Intervention | mg/dL (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 2 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0 |
[back to top]
Mean Change in Body Mass Index (BMI) in Participants at Week 48
Mean change in BMI from baseline at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | kg/m^2 (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 1.3 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0.8 |
[back to top]
Mean Change From Baseline in Waist-to-hip-ratio at Week 96
Mean change from baseline in waist-to-hip-ratio at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | ratio (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0.02 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0.01 |
[back to top]
Mean Change From Baseline in Waist-to-hip-ratio at Week 48
Mean change from baseline in waist-to-hip-ratio at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | ratio (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0.02 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0.01 |
[back to top]
Mean Change From Baseline in Waist Circumference at Week 96
Mean change From baseline in waist circumference at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.
Intervention | cm (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 6 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 2 |
[back to top]
Mean Change From Baseline in Waist Circumference at Week 48
Mean change from baseline in waist circumference at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | cm (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 2 |
[back to top]
Mean Change From Baseline in Trunk-to-limb Fat Ratio Measured by DEXA at Week 48
Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement was associated with a decrease in values. (NCT00272779)
Timeframe: DEXA scans were taken at Baseline (Day 1) and at Weeks 48.
Intervention | Ratio (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0.04 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -0.02 |
[back to top]
Mean Change From Baseline in Trunk-to-Limb Fat Ratio as Measured by Dual Energy X-ray Absorptiometry (DEXA) at Week 96
Mean changes from baseline in trunk-to-limb fat ratio as measured by DEXA, an x-ray scan used to measure bone mineral density. Clinical improvement is associated with a decrease in values. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.
Intervention | Ratio (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0.05 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0.00 |
[back to top]
Mean Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48
Mean change from baseline in CD4 cell counts was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.
Intervention | c/mm^3 (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 203 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 219 |
[back to top]
Mean Change From Baseline in CD4 Cell Count at Week 96
Mean change from baseline in CD4 count among treated participants was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | cells/mm^3 (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 268 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 290 |
[back to top]
Mean Change From Baseline in Body Weight at Week 96
Mean change from baseline in weight at Week 96 (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | kg (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 5 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 3 |
[back to top]
Mean Change From Baseline in Body Weight at Week 48
Mean change from baseline in body weight at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | kg (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 3 |
[back to top]
Mean Change From Baseline in BMI at Week 96
Mean change From baseline in BMI at Week 96 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | kg/m^2 (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 2.0 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 1.2 |
[back to top]
Mean Change From Baseline in BMI at Week 96
(NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | kg/m^2 (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 1.6 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 1.0 |
[back to top]
Mean Change From Baseline in BMI at Week 48
Mean change from baseline in BMI at Week 48 was determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.
Intervention | kg/m^2 (Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 1.5 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 1.1 |
[back to top]
Maximum Plasma Concentration (Cmax) of ATV/RTV and LPV/RTV in the Presence of an Antiretroviral (ARV) Regimen Including TDF at Week 4
Cmax was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given every day (QD) and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given twice daily (BID) and TDF given QD.
Intervention | nanogram(ng)/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 2897 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 10654 |
[back to top]
Inhibitory Quotient (IQ) of ATV and LPV When Dosed With RTV at Week 4
IQ defined as Cmin at week 4 divided by protein binding adjusted EC90 values for the respective protease inhibitor (ATV or LPV) derived from individual participant clinical isolates. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 27.33 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 35.91 |
[back to top]
Cmin of Tenofovir at Week 4
Cmin was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 72.46 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 84.98 |
[back to top]
Cmin of RTV at Week 4
Cmin was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 50.52 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 179.0 |
[back to top]
Cmax of Tenofovir at Week 4
Cmax was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 352.0 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 380.7 |
[back to top]
Cmax of RTV at Week 4
Cmax was derived from plasma concentration versus time data. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 959.8 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 657.4 |
[back to top]
AUC (TAU) of Tenofovir at Week 4
AUC (TAU) was derived from plasma concentration versus time data.It was calculated from time 0-24 hours for tenofovir in LPV/RPV and ATV/RTV regimen at Week 4. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng*h/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 3272 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 3675 |
[back to top]
AUC (0-24) of RTV at Week 4
AUC (0-24) was derived from plasma concentration versus time data. It was estimated as 2 times the AUC(TAU) based on 12-hour PK. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng*h/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 6724 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 8011 |
[back to top]
Area Under the Concentration-time Curve, in One Dosing Interval [AUC(TAU)] of ATV/RTV and LPV/RTV in the Presence of an ARV Regimen Including TDF at Week 4
AUC(TAU) was derived from the plasma concentration versus time data. It was calculated from time 0 to 12 hours for LPV and RTV in the LPV/RTV regimen, 0-24 hours for ATV and RTV in the ATV/RTV regimen, and 0-24 hours for tenofovir in both regimens at Week 4. (NCT00272779)
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 Hrs post dosing with ATV/RTV and TDF all given QD and at predose, 1, 2, 3, 4, 6, 8, 12 Hrs post dosing with LPV/RTV given BID and TDF given QD.
Intervention | ng*h/mL (Geometric Mean) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 28605 |
LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 90945 |
[back to top]
Mean Change From Baseline in Quality of Life as Measured by the Impact of Gastro-intestinal Toxicity at Week 24 Using the Irritable Bowel Syndrome Quality of Life (IBS-QoL)
The IBS-QoL questionnaire has 34 items and an overall score and 8 subscale scores: dysphoria,interference with activity,body image,health worry, food avoidance,social reaction,sexual, and relationships. Overall and subscores transformed to a 0-100 scale (0=lowest score, 100=highest possible score). Scores between these values represent the percentage of the total possible score achieved. Higher scores=better IBS-related QoL. A 14-point change from BL in IBS-QoL score in women with moderate to severe functional bowel disorders is a minimally important difference based on pain and satisfaction. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 24
Intervention | Units on a scale (Mean) |
---|
| Overall (290, 289) | Dysphoria (295, 298) | Interference with activity (294, 297) | Body image (299, 300) | Health worry (297, 300) | Food avoidance (299, 300) | Social reaction (295, 297) | Sexual (299, 299) | Relationships (297, 297) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4.3 | 4.4 | 4.4 | 1.8 | 7.5 | 5.6 | 3.2 | 4.3 | 3.3 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 1.4 | 1.8 | 0.0 | 1.1 | 5.3 | 0.4 | 0.4 | 0.8 | 1.2 |
[back to top]
Treatment Emergent Resistance in Isolates From Participants With Virologic Failure at Week 48
Participants with virologic failure are those who never suppressed (HIV RNA <400 c/mL) and were on study through Week 48, or who rebounded to HIV RNA >= 400 c/mL and those who discontinued due to insufficient viral load response. IAS=International AIDS Society, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Participants (Number) |
---|
| Virologic Failure, Week 48 (HIV RNA >= 400 c/mL) | Paired Genotypes (n = 27, 26) | Paired Phenotypes (n= 27, 26) | IAS-defined major PI substitutions (n = 17, 15) | Other IAS-defined PI substitutions (n = 17, 15) | PI phenotypic resistance (ATV/RTV FC>5.2 (n=18,16) | PI phenotypic resistance (LPV/RTV FC >9 (n=18, 16) | PI phenotypic resistance (Other PIs )(n=18, 16) | RTI Substitutions , TAMS (n= 17,15) | RTI Substitutions , M184V (n = 17,15) | RTI phenotypic resistance, FTC FC>3.5 (n = 18, 16) | RTI phenotypic resistance, TDF FC >1.4(n = 18, 16) | RTI phenotypic resistance, Other NRTIs(n = 18, 16) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 27 | 17 | 18 | 1 | 6 | 1 | 0 | 4 | 1 | 3 | 4 | 0 | 5 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 26 | 15 | 16 | 0 | 2 | 0 | 0 | 4 | 1 | 3 | 3 | 1 | 5 |
[back to top]
Number of Participants With Virologic Failure Showing Treatment Emergent Resistance Through Week 96
Virologic failure participants defined as participants who were never suppressed (HIV RNA < 400 c/mL) and on study through Week 48, or who rebounded to HIV RNA ≥ 400 c/mL, and those who discontinued due to insufficient viral load response using CVR (NC=F). IAS-USA=International AIDS Society-United States of America, PI=protease inhibitor, RTI=reverse transcription inhibitor, TAMS=Thymidine Analogue-Associated Mutations, NRTI=non-nucleotide reverse transcriptase inhibitor, M184/V= Methionine-to-valine mutation at position 184 (in reverse transcription [RT] gene), FC=fold change (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.
Intervention | Participants (Number) |
---|
| Virologic Failure, Week 96 (HIV RNA >= 400 c/mL) | Paired Genotypes (n = 28, 29) | Paired Phenotypes (n= 28, 29) | IAS-USA major PI substitutions (n = 26, 26) | IAS-USA minor PI substitutions (n = 26, 26) | PI polymorphisms without IAS-USA (n=26, 26) | PI phenotypic resistance (ATV/RTV FC >5.2 (25, 23) | PI phenotypic resistance (LPV/RTV FC>9 (25,23) | PI phenotypic resistance (Other PIs [25, 23]) | NRTI substitutions (TAMS [26, 26]) | NRTI substitutions (M184I/V [26, 26]) | RTI phenotypic resistance (FC [n = 25, 23]) | RTI phenotypic resistance (TDF [n = 25, 23]) | RTI phenotypic resistance (Other NRTI [n =25, 23]) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 28 | 26 | 25 | 1 | 1 | 11 | 1 | 0 | 3 | 1 | 5 | 5 | 0 | 5 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 29 | 26 | 23 | 0 | 1 | 14 | 0 | 1 | 6 | 3 | 7 | 5 | 2 | 6 |
[back to top]
Number of Participants With Single Nucleotide Polymorphisms (SNPs) Included in Genotype-Phenotype Analysis
19 genes of interest were selected from previous results or literature, and 34 SNPs were genotyped. Phenotype-Genotype analysis was performed using 31 of the SNPs. The genotypes of each SNP were further classified as either a minor allele carrier (MAC) group composed of heterozygous and rare homozygous genotypes, or wild type [WT, common homozygous]. (NCT00272779)
Timeframe: Baseline visit
Intervention | participants (Number) |
---|
| RETN_097 WT | RETN_097 MAC | APOE_R176C WT | APOE_R176C MAC | CCDC122_5980 WT | CCDC122_5980 MAC | IL6_5309 WT | IL6_5309 MAC | RS11030679 WT | RS11030679 MAC | APOE_C130R WT | APOE_C130R MAC | RETN_2265 WT | RETN_2265 MAC | RETN_598 WT | RETN_598 MAC | RETN_734 WT | RETN_734 MAC | BRUNOL_1842 WT | BRUNOL_1842 MAC | RETN_730 WT | RETN_730 MAC |
---|
All Participants With Pharmacogenetic Blood Samples | 164 | 35 | 182 | 16 | 126 | 71 | 57 | 141 | 112 | 87 | 169 | 30 | 146 | 53 | 119 | 80 | 175 | 22 | 121 | 77 | 99 | 100 |
[back to top]
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 96
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| Glycosuria (n = 434, 431) | Proteinuria (n = 434, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 6 | 5 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 5 | 6 |
[back to top]
Number of Participants With Laboratory Abnormalities in Urinalysis Through Week 48
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in urinalysis: Proteinuria: Grade 3: 4= or >2-3.5 g loss/day, Grade 4: >3.5 g loss/day. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| Glycosuria (n = 434, 431) | Proteinuria (n = 434, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 4 | 3 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 3 | 1 |
[back to top]
Number of Participants With Laboratory Abnormalities in Serum Enzymes Levels Through Week 48
Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: Creatine phosphokinase (CPK): Grade 3: 5.1 - 10.0 * upper limit of normal (ULN), Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| CPK (n = 435, 430) | Lipase (n = 435, 430) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 22 | 6 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 20 | 6 |
[back to top]
Number of Participants With Laboratory Abnormalities in Serum Enzyme Levels Through Week 96
Laboratory measurements marked as abnormal, as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria in serum enzymes were: CPK: Grade 3: 5.1 - 10.0 * ULN, Grade 4: >10* ULN; Lipase: Grade 3: 2.10 - 5.0* ULN, Grade 4: 5.0* ULN. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| CPK (n=435, 430) | Lipase (n=435, 430) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 34 | 9 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 28 | 9 |
[back to top]
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 96
Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: BUN: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| BUN (n = 435,431) | Creatine (n = 435, 431) | Phosphorous (n = 435, 431) | Uric acid (n = 435, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0 | 1 | 0 | 1 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0 | 2 | 1 | 4 |
[back to top]
Number of Participants With Laboratory Abnormalities in Renal Function Test Through Week 48
Renal function test abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Blood urea nitrogen (BUN): Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; Creatinine: Grade 3: 3.1 - 6*ULN, Grade 4: >6*ULN; low phosphorous (hypophosphatemia): Grade 3: 1.0- 1.4 mg/dL, Grade 4: <1.0mg/dL; high uric acid (hyperuricemia): Grade 3: 12.1 - 15.0 mg/dL, Grade 4: >15.0 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| BUN (n = 435, 431) | Creatinine (n = 435, 431) | Phosphorus (n = 435, 431) | Uric acid (n = 435, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0 | 1 | 0 | 0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0 | 1 | 1 | 3 |
[back to top]
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 96
Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per NCI-CTCAE. Grade 3 and 4 criteria were: ALT, AST, alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| ALT (n= 435, 431) | AST (n = 435, 430) | Albumin (n = 435, 431) | Alkaline Phosphatase (n= 435, 430) | Total Bilirubin (n = 435, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 11 | 11 | 0 | 1 | 192 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 7 | 5 | 0 | 1 | 3 |
[back to top]
Number of Participants With Laboratory Abnormalities in Liver Function Test Through Week 48
Liver function tests abnormalities were graded as per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), while albumin was graded as per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 3 and 4 criteria were: alanine aminotransferase (ALT), aspartate aminotransferase(AST), alkaline phosphatase: Grade 3: 5.1- 10*ULN, Grade 4: >10*ULN; direct and total bilirubin: Grade 3: 2.6- 5*ULN, Grade 4: >5*ULN, Albumin: Grade 3: <2g/dL. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| ALT (n= 435, 431) | AST (n = 435, 430) | Albumin (n = 435, 431) | Alkaline Phosphatase (n= 435, 430) | Direct Bilirubin (n = 435, 430) | Total Bilirubin (n = 435, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 8 | 9 | 0 | 1 | 37 | 146 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 6 | 2 | 0 | 1 | 4 | 1 |
[back to top]
Number of Participants With Laboratory Abnormalities in Hematology: Hemoglobin, Hematocrit, Platelet Count, INR, Neutrophils, PT and WBC Through Week 96
Hematology abnormalities were graded per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| Hematocrit (n= 434, 431) | Hemoglobin (n= 434, 431) | INR (n= 435, 431) | Neutrophils (n = 434, 431) | Platelets ( n= 433, 431) | Prothrombin time (n = 435, 431) | WBC (n = 434, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0 | 3 | 7 | 21 | 5 | 9 | 0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 6 | 7 | 18 | 7 | 1 | 24 | 1 |
[back to top]
Number of Participants With Laboratory Abnormalities in Hematology Through Week 48: Hemoglobin, Hematocrit, Platelet Count, International Normalized Ratio (INR), Neutrophils, Prothrombin Time (PT) and White Blood Cells (WBC)
Hematology abnormalities were graded per modified World Health Organization (WHO) criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe). Grade 3 and 4 criteria were: Hemoglobin: Grade 3: 6.5-7.9 g/dL, Grade 4: <6.5 g/dL; Hematocrit: Grade 3: >=19.5 - 24%, Grade 4: <19.5%; platelet count: Grade 3: 20,000- 49, 999/ mm^3, Grade 4: <20,000/mm^3; INR: Grade 3 Absolute Neutrophil Count (ANC): Grade 3: >= 500 - <750/mm^3, Grade 4: <500/mm^3; PT: Grade 3: 1.51 - 3.0*ULN, Grade 4: >3*ULN; WBC: Grade 3: >=800 to <1000/mm^3, Grade 4: <80/mm^3. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| Hematocrit (n= 434, 431) | Hemoglobin (n= 434, 431) | INR (n= 435, 431) | Neutrophils (n = 434, 431) | Platelets ( n= 433, 430) | PT (n = 435, 431) | WBC (n = 434, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0 | 2 | 6 | 14 | 5 | 6 | 0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 6 | 6 | 11 | 3 | 1 | 16 | 0 |
[back to top]
Number of Participants With Laboratory Abnormalities in Fasting Lipids Through Week 48
Laboratory measurements marked as abnormal, as per National Cholesterol Education Program (NCEP)- Adult Treatment Panel (ATP)-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| Total Cholesterol (n = 434, 428) | Triglycerides (n = 434, 428) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 30 | 2 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 77 | 15 |
[back to top]
Number of Participants With Laboratory Abnormalities in Fasting Lipids Level Through Week 96
Laboratory measurements marked as abnormal, as per NCEP-ATP-III guided categories. The following definitions specify the criteria for MAs in fasting lipids: Total cholesterol: Grade 3: 240 - 300 mg/dL, Grade 4: >=240 mg/dL, triglycerides: Grade 3: 200 - <500 mg/dL, Grade 4: >=500 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| Total Cholesterol (n = 434, 428) | Triglycerides (n = 434, 428) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 47 | 3 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 108 | 18 |
[back to top]
Number of Participants With Laboratory Abnormalities in Fasting Glucose Through Week 48
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| Hyperglycemia (n = 434, 428) | Hypoglycemia (n = 434, 428) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 1 | 0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 1 | 0 |
[back to top]
Number of Participants With Laboratory Abnormalities in Fasting Glucose Levels Through Week 96
Laboratory measurements marked as abnormal, per modified WHO criteria (Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = very severe), at any study time point. The following Grade 3 and 4 definitions specify the criteria for MAs in fasting glucose: hypoglycemia: Grade 3: 30-39 mg/dL, Grade 4: <30 mg/dL; hyperglycemia: 251-500 mg/dL, Grade 4: >500 mg/dL. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| Hyperglycemia (n = 434, 428) | Hypoglycemia (n = 434, 428) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 3 | 1 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 2 | 0 |
[back to top]
Number of Participants With Laboratory Abnormalities in Electrolytes Through Week 48
Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L. (NCT00272779)
Timeframe: At Screening (Day -30), Baseline (Day 1), Week 4, 12, 24, 36, and 48.
Intervention | Participants (Number) |
---|
| Hypercarbia (n = 435, 431) | Hypocarbia (n = 435, 431) | Hypercalcemia (n = 435, 431) | Hypocalcemia (n = 435, 431) | Hyperchloremia (n = 435, 431) | Hypochloremia (n = 435, 431) | Hyperkalemia (n = 435, 430) | Hypokalemia (n = 435, 430) | Hypernatremia (n = 435, 431) | Hyponatremia (n = 435, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0 | 7 | 0 | 4 | 0 | 0 | 1 | 1 | 0 | 1 |
[back to top]
Number of Participants With Laboratory Abnormalities in Electrolytes Level Through Week 96
Serum electrolytes abnormalities,graded per modified WHOcriteria.Ranges were:hypercarbia:Grade3:41-45milliequivalents(meq)/L,Grade4:>45meq/L;hypocarbia:Grade3:10-14 meq/L,Grade4:<10 meq/L;hypercalcemia:Grade3:12.6 - 13.5 mg/dL,Grade 4:>13.5 mg/dL;hypocalcemia:6.1-6.9mg/dL,Grade4:<6.1mg/dL;hyperchloremia:Grade 3: 121-125 meq/L,Grade4:>125meq/L;hypochloremia:Grade 3:80-84 meq/L,Grade4:<80meq/L;hyperkalemia:Grade3:6.6-7.0meq/L,Grade4:>7.0meq/L;hypokalemia:Grade3:2.0-2.4 meq/L,Grade4:<2.0meq/L;hypernatremia:Grade3:158-165 meq/L,Grade4:>165meq/L;hyponatremia:Grade 3:116-122 meq/L,Grade 4:115 meq/L. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | Participants (Number) |
---|
| Hypercarbia (n = 435, 431) | Hypocarbia (n = 435, 431) | Hypercalcemia (n = 435, 431) | Hypocalcemia (n = 435, 431) | Hyperchloremia (n = 435, 431) | Hypochloremia (n = 435, 431) | Hyperkalemia (n = 435, 430) | Hypokalemia (n = 435, 430) | Hypernatremia (n = 435, 431) | Hyponatremia (n = 435, 431) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0 | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0 | 8 | 0 | 4 | 0 | 2 | 1 | 1 | 2 | 2 |
[back to top]
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced Events Leading to Discontinuation Through Week 96
AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match. (NCT00272779)
Timeframe: From Day 1 through Week 96
Intervention | Participants (Number) |
---|
| Deaths | Serious Adverse Events (SAEs) | Adverse Events (AEs) leading to discontinuation |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 6 | 63 | 13 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 6 | 50 | 22 |
[back to top]
Number of Participants Who Died, Experienced Other Serious Adverse Events (SAEs), Experienced Adverse Events (AEs) and Experienced AEs Leading to Discontinuation Through Week 48
AEs:new,untoward medical occurrences/worsening of pre-existing medical condition,drug-related or not.SAEs:any AE that:resulted in death;was life threatening;resulted in a persistent or significant disability/incapacity;resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was cancer;or overdose.Discontinuation from study was due either to an AE or was conducted at the investigator's discretion.AEs represented here include SAEs, which are not included in the AE count represented in the AE xml upload section. As such, these numbers may not match. (NCT00272779)
Timeframe: From baseline (Day 1) to Week 48.
Intervention | Participants (Number) |
---|
| Deaths | Other SAEs | AEs | AEs leading to discontinuation |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 6 | 51 | 400 | 11 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 6 | 42 | 399 | 15 |
[back to top]
[back to top]
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 96
The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96.
Intervention | Percentage (Mean) |
---|
| Trunk Fat | Limb Fat | Total Body Fat |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 34 | 27 | 29 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 16 | 15 | 15 |
[back to top]
Mean Percent Changes From Baseline in Limb, Trunk and Total Body Fat Measured by DEXA at Week 48
The mean percent change from baseline in limb, trunk and total body fat was measured by DEXA. Limb fat: a physical sign of lipoatrophy, clinical improvement in limb fat is associated with a decrease in values. Trunk fat: a physical sign of lipohypertrophy, clinical improvement in trunk fat is associated with a decrease in values. Total body fat: association of many factors like trunk fat, limb fat, weight etc. Clinical improvement in total body fat cannot be predicted based solely an increase or decrease of these values. (NCT00272779)
Timeframe: DEXA scans were performed at baseline (within 30 days of starting study treatment), and at Weeks 48.
Intervention | Percentage (Mean) |
---|
| Trunk Fat | Limb Fat | Total Body Fat |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 26 | 22 | 23 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 16 | 17 | 15 |
[back to top]
Mean Percent Changes From Baseline in Bone Mineral Density (BMD) Measured by DEXA at Week 48
Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique. (NCT00272779)
Timeframe: DEXA scans were taken at Baseline (Day 1) and Week 48.
Intervention | grams/ centimeters ^2 (g/cm^2) (Mean) |
---|
| Bone Mineral Density of Both Arms | Bone Mineral Density of Both Legs | Bone Mineral Density of Trunk | Bone Mineral Density of Total Body |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -1 | -2 | -4 | -2 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -1 | -2 | -4 | -3 |
[back to top]
Mean Percent Changes From Baseline in BMD Measured by DEXA at Week 96
Mean percent change from baseline in BMD of arms, legs, trunk and total body was measured using DEXA, an X-ray scan technique. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 96
Intervention | g/cm^2 (Mean) |
---|
| Bone Mineral Density of Both Arms | Bone Mineral Density of Both Legs | Bone Mineral Density of Trunk | Bone Mineral Density of Total Body |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -1 | -2 | -3 | -3 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -2 | -3 | -5 | -4 |
[back to top]
Mean Changes in Fasting Lipids at Week 96
Mean change from baseline in fasting lipids at Week 96 was determined. (NCT00272779)
Timeframe: At screening (Day -30), baseline (Day 1), Week 4, 12, 24, 36, 48, 60, 72, 84 and 96.
Intervention | mg/dL (Mean) |
---|
| Fasting total Cholesterol (n=342, 291) | Fasting HDL Cholesterol (n=341, 291) | Fasting Non-HDL Cholesterol (n=341, 291) | Fasting LDL Cholesterol (n=342, 291) | Fasting Triglycerides (n=342, 291) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 20 | 7.0 | 13.0 | 12.0 | 16.0 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 37 | 10.0 | 27.0 | 17.0 | 63.0 |
[back to top]
Mean Change in Fasting Lipid at Week 48
Mean change from baseline in fasting lipids, for fasting total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol, and triglycerides at Week 48 were determined. (NCT00272779)
Timeframe: Baseline (Day 1) and Week 48.
Intervention | milligrams/deciliter (mg/dL) (Mean) |
---|
| Fasting total Cholesterol (n=373, 337) | Fasting HDL Cholesterol (n=371, 335) | Fasting Non-HDL Cholesterol (n=371, 335) | Fasting LDL Cholesterol (n=372, 335) | Fasting Triglycerides (n=373, 337) |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 19 | 9 | 10 | 12 | 20 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 38 | 12 | 26 | 18 | 70 |
[back to top]
Mean Change From Baseline in Visceral Adipose Tissue (VAT) Associated With BRUNOL_1842
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | cm^2 (Mean) |
---|
| VAT: BRUNOL_1842 WT | VAT: BRUNOL_1842 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 23.45 | -3.20 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 10.38 | -1.76 |
[back to top]
Mean Change From Baseline in VAT-to-TAT Ratio Associated With CCDA122_5980
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT and TAT were measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | cm^2 (Mean) |
---|
| VAT-to-TAT Ratio: CCDA122_5980 WT | VAT-to-TAT Ratio: CCDA122_5980 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -0.03 | -0.11 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | -0.03 | -0.02 |
[back to top]
Mean Change From Baseline in VAT Associated With RETN_730
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. VAT was measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | cm^2 (Mean) |
---|
| VAT: RETN_730 WT | VAT: RETN_730 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | -2.95 | 23.29 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 13.69 | -1.05 |
[back to top]
Mean Change From Baseline in Subcutaneous Adipose Tissue (SAT)-To-Trunk Adipose Tissue (TAT) Ratio Associated With CCDC122_5980
The change-from-baseline was defined as the difference between the averages of post-treatment time points (Weeks 48 and 96) and baseline. Association analysis for each SNP was performed using a minor allele carrier (MAC) composed of heterozygous and rare homozygous genotypes, and wild type (WT, common homozygous). False discovery rate (FDR)-adjusted p-values were calculated for each phenotype-genotype pair. SAT and TAT were measured by computed tomography (CT). (NCT00272779)
Timeframe: Baseline (Day 1), Week 48, and Week 96.
Intervention | cm^2 (Mean) |
---|
| SAT-to-TAT Ratio: CCDC122_5980 WT | SAT-to-TAT Ratio: CCDC122_5980 MAC |
---|
ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD | 0.03 | 0.11 |
,LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD | 0.03 | 0.02 |
[back to top]
Percentage of Participants With Hepatitis B Early Antigen (HBeAg) Loss and HBeAg Seroconversion at Week 48 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
| HBeAg Loss | HBeAg Seroconversion |
---|
Entecavir | 0.0 | 0.0 |
,FTC/TDF | 26.7 | 13.3 |
,Overall | 19.4 | 13.9 |
,Tenofovir DF | 21.4 | 21.4 |
[back to top]
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 96 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 96
Intervention | percentage of participants (Number) |
---|
| HBeAg Loss | HBeAg Seroconversion |
---|
Entecavir | 0.0 | 0.0 |
,FTC/TDF | 33.3 | 13.3 |
,Overall | 20.0 | 11.4 |
,Tenofovir DF | 14.3 | 14.3 |
[back to top]
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 96
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 96
Intervention | percentage of participants (Number) |
---|
| HBsAg Loss | HBsAg Seroconversion |
---|
Entecavir | 0.0 | 0.0 |
,FTC/TDF | 0.0 | 0.0 |
,Overall | 0.0 | 0.0 |
,Tenofovir DF | 0.0 | 0.0 |
[back to top]
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 168
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
| HBsAg Loss | HBsAg Seroconversion |
---|
Entecavir | 0.0 | 0.0 |
,FTC/TDF | 0.0 | 0.0 |
,Overall | 0.0 | 0.0 |
,Tenofovir DF | 0.0 | 0.0 |
[back to top]
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 144
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 144
Intervention | percentage of participants (Number) |
---|
| HBsAg Loss | HBsAg Seroconversion |
---|
Entecavir | 0.0 | 0.0 |
,FTC/TDF | 0.0 | 0.0 |
,Overall | 0.0 | 0.0 |
,Tenofovir DF | 0.0 | 0.0 |
[back to top]
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 144
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 144
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 0.0 |
FTC/TDF | 2.5 |
Entecavir | 0.0 |
Overall | 1.0 |
[back to top]
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 168
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 2.4 |
FTC/TDF | 0.0 |
Entecavir | 0.0 |
Overall | 1.0 |
[back to top]
Percentage of Participants With an Increase in CPT Score of ≥ 2 Points at Week 96
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 96
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 0.0 |
FTC/TDF | 0.0 |
Entecavir | 0.0 |
Overall | 0.0 |
[back to top]
Percentage of Participants With Baseline ADV-R + LAM-R Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
ADV resistance mutation + LAM resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation, and the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 50 |
[back to top]
Percentage of Participants With Normalized Alanine Aminotransferase (ALT) (for Subjects With Elevated ALT at Baseline) at Week 48
Normalized ALT is defined as having a baseline ALT value > the upper limit of the normal range (ULN), and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 46.2 |
FTC/TDF | 64.0 |
Entecavir | 41.2 |
Overall | 51.5 |
[back to top]
Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 144
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 144
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 34.6 |
FTC/TDF | 64.0 |
Entecavir | 37.5 |
Overall | 46.3 |
[back to top]
[back to top]
Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 168
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 29.2 |
FTC/TDF | 60.0 |
Entecavir | 37.5 |
Overall | 43.1 |
[back to top]
Percentage of Participants With Normalized ALT (for Subjects With Elevated ALT at Baseline) at Week 96
Normalized ALT is defined as having a baseline ALT value > ULN, and a decrease in ALT value to ≤ ULN at the given time point. (NCT00298363)
Timeframe: Baseline to Week 96
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 50.0 |
FTC/TDF | 58.3 |
Entecavir | 31.3 |
Overall | 48.5 |
[back to top]
Percentage of Participants With Only Baseline Adefovir Dipivoxil Resistance (ADV-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
ADV resistance mutations are defined as the presence of the rtA181T/V HBV gene mutation and/or the rtN236T HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 100 |
FTC/TDF | 100 |
[back to top]
Percentage of Participants With Only Baseline Lamivudine-resistance (LAM-R) Mutations Achieving HBV DNA < 400 Copies/mL by 168 Weeks
LAM resistance mutations are defined as the presence of the rtM204V/I HBV gene mutation with or without the rtL180M HBV gene mutation. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 100 |
FTC/TDF | 100 |
Entecavir | 100 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 144
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 144 was summarized. (NCT00298363)
Timeframe: Week 144
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 50.0 |
FTC/TDF | 77.5 |
Entecavir | 52.4 |
Overall | 61.0 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 168 was summarized. (NCT00298363)
Timeframe: Week 168
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 50.0 |
FTC/TDF | 75.7 |
Entecavir | 52.4 |
Overall | 60.0 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 48 was summarized. (NCT00298363)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 70.5 |
FTC/TDF | 87.8 |
Entecavir | 72.7 |
Overall | 77.6 |
[back to top]
In the Subset of Participants Undergoing Liver Transplantation, Time to Recurrence of Hepatitis B, Defined as 2 Consecutive Plasma HBV DNA Concentrations ≥ 400 Copies/mL or 2 Consecutive HBsAg(+) Results
(NCT00298363)
Timeframe: Baseline to Week 168
Intervention | Days (Number) |
---|
Tenofovir DF | NA |
FTC/TDF | NA |
Entecavir | NA |
Overall | NA |
[back to top]
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 48
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 25.9 |
FTC/TDF | 48.0 |
Entecavir | 41.7 |
Overall | 37.5 |
[back to top]
Percentage of Participants With an Increase in Child-Pugh Turcotte (CPT) Score of ≥ 2 Points at Weeks 48
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 0.0 |
FTC/TDF | 2.6 |
Entecavir | 0.0 |
Overall | 1.0 |
[back to top]
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 96
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 96
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 23.1 |
FTC/TDF | 52.0 |
Entecavir | 50.0 |
Overall | 39.3 |
[back to top]
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 168
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 24.0 |
FTC/TDF | 45.8 |
Entecavir | 45.5 |
Overall | 36.7 |
[back to top]
Percentage of Participants With a Decrease in CPT Score of ≥ 2 Points From Baseline at Week 144
CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. (NCT00298363)
Timeframe: Baseline to Week 144
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 25.9 |
FTC/TDF | 51.9 |
Entecavir | 45.5 |
Overall | 40.0 |
[back to top]
Percent Probability of Tolerability Failure
Tolerability failure was defined as permanent discontinuation of study drug due to a treatment-emergent adverse event (AE), including any subject who temporarily discontinued study drug due to an AE and did not restart. Results are expressed as proportions of participants who experience tolerability failure using the Kaplan-Meier (KM) method of estimation. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percent probability (KM estimate) (Number) |
---|
Tenofovir DF | 18 |
FTC/TDF | 4 |
TDF or FTC/TDF | 11 |
Entecavir | 14 |
[back to top]
Percent Probability of a Confirmed Increase in Serum Creatinine of ≥ 0.5 mg/dL From Baseline or a Confirmed Serum Phosphorus Level < 2.0 mg/dL
Results are expressed as proportions of participants who experience a confirmed increase in serum creatinine of ≥ 0.5 mg/dL from baseline or a confirmed serum phosphorus level < 2.0 mg/dL using the KM method of estimation. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percent probability (KM estimate) (Number) |
---|
Tenofovir DF | 15 |
FTC/TDF | 14 |
TDF or FTC/TDF | 14 |
Entecavir | 10 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 96
The percentage of participants with plasma HBV DNA < 400 copies/mL at Week 96 was summarized. (NCT00298363)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 59.1 |
FTC/TDF | 79.5 |
Entecavir | 57.1 |
Overall | 66.3 |
[back to top]
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 144 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 144
Intervention | percentage of participants (Number) |
---|
| HBeAg Loss | HBeAg Seroconversion |
---|
Entecavir | 16.7 | 0.0 |
,FTC/TDF | 33.3 | 13.3 |
,Overall | 22.9 | 11.4 |
,Tenofovir DF | 14.3 | 14.3 |
[back to top]
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 168 (for Participants Who Were HBeAg Positive at Baseline)
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 168
Intervention | percentage of participants (Number) |
---|
| HBeAg Loss | HBeAg Seroconversion |
---|
Entecavir | 16.7 | 0.0 |
,FTC/TDF | 35.7 | 21.4 |
,Overall | 27.3 | 18.2 |
,Tenofovir DF | 23.1 | 23.1 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 48
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. (NCT00298363)
Timeframe: Baseline to Week 48
Intervention | percentage of participants (Number) |
---|
| HBsAg Loss | HBsAg Seroconversion |
---|
Entecavir | 0.0 | 0.0 |
,FTC/TDF | 0.0 | 0.0 |
,Overall | 0.0 | 0.0 |
,Tenofovir DF | 0.0 | 0.0 |
[back to top]
Hepatitis B Early Antigen (HBeAg) Loss at Week 168
Defined as having negative serum HBeAg for subjecst with positive HBeAg at baseline. (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 21.6 |
Emtricitibine/Tenofovir DF | 24.3 |
[back to top]
Change From Baseline in log10 Plasma HBV DNA Levels at Week 168
(NCT00307489)
Timeframe: 168 weeks
Intervention | log10 copies/mL (Mean) |
---|
Tenofovir DF | -3.79 |
Emtricitibine/Tenofovir DF | -3.48 |
[back to top]
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 168
(NCT00307489)
Timeframe: 168 weeks
Intervention | U/mL (Mean) |
---|
Tenofovir DF | -26.8 |
Emtricitibine/Tenofovir DF | -54.5 |
[back to top]
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Week 48
(NCT00307489)
Timeframe: 48 Weeks
Intervention | U/mL (Mean) |
---|
Tenofovir DF | -21.6 |
Emtricitibine/Tenofovir DF | -41.4 |
[back to top]
HBsAg Loss at Week 168
Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline. (NCT00307489)
Timeframe: 168 weeks
Intervention | Participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 48
(NCT00307489)
Timeframe: 48 Weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 81.1 |
Emtricitibine/Tenofovir DF | 80.8 |
[back to top]
Percentage of Participants With Normalized ALT at Week 48
Subjects with elevated ALT at baseline that return to normal by Week 48. (NCT00307489)
Timeframe: 48 Weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 40.7 |
Emtricitibine/Tenofovir DF | 61.5 |
[back to top]
HBeAg Seroconversion at Week 48
Defined as having negative serum HBeAg and positive serum antibody to HBeAg [anti-HBe] for subjects with positive serum HBeAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 2 |
Emtricitibine/Tenofovir DF | 3 |
[back to top]
Change From Baseline in log10 Plasma HBV DNA Levels at Week 48
(NCT00307489)
Timeframe: 48 Weeks
Intervention | log10 copies/mL (Mean) |
---|
Tenofovir DF | -3.58 |
Emtricitibine/Tenofovir DF | -3.34 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 400 Copies/mL at Week 168
(NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 82.4 |
Emtricitibine/Tenofovir DF | 84.0 |
[back to top]
HBsAg Loss at Week 48
Defined as having negative serum HBsAg for subjects with positive HBsAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48
(NCT00307489)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 75.5 |
Emtricitibine/Tenofovir DF | 69.2 |
[back to top]
Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 168
P-values were from a Cochran-Mantel-Haenszel test, controlling for baseline HBeAg status and prior lamivudine use. (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 80.4 |
Emtricitibine/Tenofovir DF | 78.0 |
[back to top]
Percentage of Participants With Normalized ALT at Week 168
Subjects with elevated ALT at baseline that return to normal by Week 48. (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 68.0 |
Emtricitibine/Tenofovir DF | 70.8 |
[back to top]
Percentage of Participants With Normal ALT at Week 48
ULN for males = 43 U/L; 34 U/L for females (NCT00307489)
Timeframe: 48 Weeks
Intervention | percentage of participants (Number) |
---|
Tenofovir DF | 66.7 |
Emtricitibine/Tenofovir DF | 73.1 |
[back to top]
Percentage of Participants With Normal ALT at Week 168
ULN for males = 43 U/L; ULN for females = 34 U/L (NCT00307489)
Timeframe: 168 weeks
Intervention | Percent of Participants (Number) |
---|
Tenofovir DF | 74.0 |
Emtricitibine/Tenofovir DF | 74.0 |
[back to top]
Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 48
Defined as having negative serum HBsAg and positive serum antibody to HBsAg [anti-HBs] for subject with positive serum HBsAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
[back to top]
Hepatitis B Surface Antigen (HBsAg) Seroconversion at Week 168
Defined as having negative serum BHsAg and positive serum antibody to HBsAg (anti-HBs) for subject with positive serum BHsAg at baseline. (NCT00307489)
Timeframe: 168 weeks
Intervention | Participants (Number) |
---|
Tenofovir DF | 1 |
Emtricitibine/Tenofovir DF | 0 |
[back to top]
Hepatitis B Early Antigen (HBeAg) Loss at Week 48
Defined as having negative serum HBeAg for subjects with positive HBeAg at baseline. (NCT00307489)
Timeframe: 48 Weeks
Intervention | participants (Number) |
---|
Tenofovir DF | 3 |
Emtricitibine/Tenofovir DF | 3 |
[back to top]
Time Weighted Mean Change From Baseline Plasma HIV-RNA
(NCT00335322)
Timeframe: 144 weeks
Intervention | log copies/mL (Mean) |
---|
TDF/FTC+EFV | -2.77 |
TDF/FTC+ r/ATV | -2.88 |
TDF/FTC + AZT+ABC | -2.54 |
[back to top]
Time-weighted Mean Change From Baseline Plasma HIV-RNA.
(NCT00335322)
Timeframe: 48 weeks
Intervention | log copies/mL (Mean) |
---|
TDF/FTC+EFV | -2.59 |
TDF/FTC+r/ATV | -2.69 |
TDF/FTC+AZT+ABC | -2.39 |
[back to top]
Number of Participants With Study-targeted Diagnoses and Clinical Events
Cardiac disorders, Infections and infestations, Metabolism and nutrition disorders, Neoplasms benign, malignant and unspecified (including cysts and polyps), Pregnancy, puerperium and perinatal conditions, Vascular disorders, were specified a priori as study-targeted events by the study chair. (NCT00357552)
Timeframe: Study entry to week 104
Intervention | participants (Number) |
---|
LPV/r Monotherapy | 39 |
[back to top]
Probability of Grade 3 or 4 Sign or Symptom, or Laboratory Toxicity Over 24 Weeks on Study.
Probability of Grade 3 or 4 sign or symptom, or laboratory toxicity over 24 weeks on study using Kaplan-Meier estimates of the cumulative probability of Grade 3 or 4 sign or symptom, or laboratory toxicity at week 24. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. (NCT00357552)
Timeframe: From study entry to week 24
Intervention | cumulative probability of grade 3 or 4 (Number) |
---|
LPV/r Monotherapy | 0.23 |
[back to top]
Time to Treatment Failure, Defined as the First Occurrence of Death, Disease Progression, or Virologic Failure.
25th percentile in weeks from study entry to treatment failure, defined as the first occurrence of death, disease progression, or virologic failure. Virologic failure was defined as HIV-1 >= 400 copies/mL after week 24 or 2 consecutive HIV-1 RNA >= 400 copies/mL after week 16 following suppression on LPV/r monotherapy. (NCT00357552)
Timeframe: Study entry to Week 104
Intervention | weeks (Number) |
---|
LPV/r Monotherapy | 48.0 |
[back to top]
Level of HIV-1 RNA as Ascertained From Paired DBS and Plasma
Proportion of DBS samples with HIV-1 RNA level <= 400 copies/mL, proportion of plasma samples with HIV-1 RNA level <= 400 copies/mL and proportion of paired DBS and plasma samples that are concordant (both <= 400 copies/mL or both > 400 copies/mL). Results are pooled over 4 different storage temperature conditions (-80C, -20C, 4C and room temperature). (NCT00357552)
Timeframe: At study entry and weeks 24 and 48
Intervention | proportion of samples (Number) |
---|
| study entry DBS <= 400 cp/mL | study entry plasma <= 400 cp/mL | study entry DBS & plasma concordance | week 24 DBS <= 400 cp/mL | week 24 plasma <= 400 cp/mL | week 24 DBS & plasma concordance | week 48 DBS <= 400 cp/mL | week 48 plasma <= 400 cp/mL | week 48 DBS & plasma concordance |
---|
LPV/r Monotherapy | 0.17 | 0.00 | 0.83 | 0.82 | 0.80 | 0.80 | 0.94 | 0.91 | 0.97 |
[back to top]
Number of Screened Subjects With at Least One NNRTI, or NRTI-associated Resistance Mutation at A5230 Screening.
Number of screened subjects with at least one NNRTI, or NRTI-associated resistance mutation. Resistance interpretations used the November 30, 2011 Stanford algorithm. (NCT00357552)
Timeframe: Screening
Intervention | number of screened subjects (Number) |
---|
| At least one NNRTI-associated mutation | At least one NRTI-associated mutation |
---|
All Screened Subjects With Available Sequences | 201 | 197 |
[back to top]
Percentage of Subjects Reporting Not Skipping Medications in the Last Month.
The percentage of subjects reporting never missing medications in the last month. (NCT00357552)
Timeframe: Study entry and weeks 2, 4, 8, 12, 16, 20, and 24
Intervention | percentage of subjects with data (Number) |
---|
| week 2 (N=120) | week 4 (N=121) | week 8 (N=123) | week 12 (N=123) | week 16 (N=122) | week 20 (N=120) | week 24 (N=122) |
---|
LPV/r Monotherapy | 90 | 86.8 | 87.8 | 86.2 | 86.1 | 90.9 | 89.4 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA Levels < 400 Copies/mL From Baseline to Week 104
(NCT00357552)
Timeframe: At Weeks 0, 12, 16, 20, 24, 32, 40, 48, 56, 68, 80, 92, 104
Intervention | proportion of participants (Number) |
---|
| week 0 (N=123) | week 12 (N=122) | week 16 (N=121) | week 20 (N=115) | week 24 (N=122) | week 32 (N=121) | week 40 (N=118) | week 48 (N=118) | week 56 (N=120) | week 68 (N=116) | week 80 (N=117) | week 92 (N=116) | week 104 (N=117) |
---|
LPV/r Monotherapy | 0.02 | 0.75 | 0.87 | 0.84 | 0.84 | 0.83 | 0.84 | 0.87 | 0.86 | 0.91 | 0.85 | 0.87 | 0.89 |
[back to top]
Percentage of Enrolled Participants With Virologic Success at Week 24 on LPV/r Monotherapy
Virologic success at week 24 on LPV/r monotherapy was defined as remaining on LPV/r monotherapy at week 24 without prior virologic failure. Virologic failure was met with either of these two conditions: (i) failure to suppress HIV-1 RNA to < 400 copies/mL by week 24 or (ii) confirmed HIV-1 RNA >= 400 copies/mL after confirmed HIV-1 RNA < 400 copies/mL. (NCT00357552)
Timeframe: From study entry to week 24
Intervention | percentage of enrolled subjects (Number) |
---|
LPV/r Monotherapy | 87 |
[back to top]
Number of Subjects With at Least One New PI-associated Resistance Mutation at Time of Virologic Failure.
Number of subjects with at least one new PI-associated resistance mutation at time of virologic failure. Resistance interpretations used the May 6, 2009 Stanford algorithm. (NCT00357552)
Timeframe: At time of virologic failure
Intervention | participants (Number) |
---|
Virologic Failures by Week 24. | 2 |
[back to top]
Time to First New Grade 3 or 4 Sign or Symptom or Laboratory Toxicity Following LPV/r Intensification
25th percentile in weeks from study entry to first new grade 3 or 4 sign or symptom or laboratory toxicity following LPV/r intensification. Grading of adverse events (signs and symptoms and laboratory toxicities) was according to Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004. (NCT00357552)
Timeframe: From LPV/r intensification to week 104
Intervention | weeks (Number) |
---|
LPV/r Monotherapy | 26.0 |
[back to top]
Change in CD4+ Cell Counts From Study Entry to Week 104
(NCT00357552)
Timeframe: Study entry and week 104
Intervention | cells/mm^3 (Median) |
---|
LPV/r Monotherapy | 213 |
[back to top]
Apparent Oral Clearance Adjusted for Body Weight (CLT/F/kg) of EFV at Week 2 - Pharmacokinetic Evaluable Population
Plasma concentrations of EFV were determined using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg). (NCT00364793)
Timeframe: Week 2
Intervention | L/h/kg (Geometric Mean) |
---|
EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 2.07 |
EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 2.36 |
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 1.44 |
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 0.66 |
[back to top]
Area Under the Plasma Concentration Time Curve (AUC) Over One Dosing Interval From Time Zero to 24 Hours Post-dose(TAU) at Week 2 - Pharmacokinetic Evaluable Population
Plasma concentrations were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in micromolars*time (µM•h). (NCT00364793)
Timeframe: Week 2
Intervention | µM•h (Geometric Mean) |
---|
EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 129.5 |
EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 71.4 |
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 93.8 |
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 130.8 |
[back to top]
AUC (TAU) of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Plasma concentrations were obtained using a validated LC-MS/MS at Week 2. The lower limit of quantification (LLOQ) for ddI was 2.50 nanograms per milliliter (ng/mL). AUC(TAU) was calculated by log- and linear trapezoidal summations. If a concentration was < LLOQ at time TAU, the value of the concentration at time TAU was estimated using the quotient of the last quantifiable concentration and λ. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters summarized using geometric means. AUC(TAU) was measured in nanograms*time per milliliter (ng•h/mL). (NCT00364793)
Timeframe: Week 2
Intervention | ng•h/mL (Geometric Mean) |
---|
EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 1445 |
EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 2848 |
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 1038 |
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 1000 |
[back to top]
CLT/F of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F was calculated by dividing the dose of ddI by AUC(TAU) of ddI. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h). (NCT00364793)
Timeframe: Week 2
Intervention | L/h (Geometric Mean) |
---|
EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 40.7 |
EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 35.6 |
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 113.9 |
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 143.0 |
[back to top]
CLT/F/kg of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). CLT/F/kg was calculated by dividing CLT/F by body weight in kilograms (kg). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F/kg was measured in liters per hour per kilogram (L/h/kg). (NCT00364793)
Timeframe: Week 2
Intervention | L/h/kg (Geometric Mean) |
---|
EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 7.88 |
EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 4.26 |
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 11.36 |
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 10.34 |
[back to top]
Terminal Phase Elimination Half-life (T-HALF) in Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. The LLOQ for ddI was 2.50 nanograms per milliliter (ng/mL). Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the T-HALF was summarized using a mean. Terminal elimination plasma half-life=ln2 divided by K where K is the absolute value of the slope of the terminal phase of the plasma profile as determined by log-linear regression of at least three data points. T-HALF was measured in hours (h). (NCT00364793)
Timeframe: Week 2
Intervention | h (Mean) |
---|
EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 0.92 |
EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 1.41 |
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 1.73 |
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 1.14 |
[back to top]
CD4 Cell Count Change From Baseline at Weeks 24 and 48 - Treated Participants
A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 24 and 48
Intervention | cells/mm^3 (Median) |
---|
| Baseline (n=10, 9, 3, 6, 28) | Week 24 (n=6, 7, 3, 6, 22) | Week 48 (n=7, 8, 2, 5, 22) |
---|
EFV+ddI+FTC in All Participants | 1144 | 177 | 196 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 517 | 31 | 971 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 413 | 283 | 284 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 1518 | 259 | -258 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 1569 | 82 | 346 |
[back to top]
Cmax and Cmin of Didanosine (ddI) at Week 2 - Pharmacokinetic Evaluable Population
Cmax and Cmin were derived from plasma concentration versus time. Plasma concentrations for ddI were determined using a validated LC/MS/MS assay. All reportable Cmin values were =6 months to < 2 years (Group 2); LLOQ/2 was imputed for those summary statistics;in Group 2, 9 of 10 Cmin values were NCT00364793)
Timeframe: Week 2
Intervention | ng/mL (Geometric Mean) |
---|
| Cmax (n=12, 10, 4, 6) | Cmin (n=4, 10, 4, 3) |
---|
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 356 | 1.25 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 376 | 1.25 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 850 | 1.25 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 1193 | 1.54 |
[back to top]
Log10 c/mL HIV RNA Changes From Baseline at Weeks 60, 72, 84 and 96 - Treated Participants
HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline through Weeks 60, 72, 84, and 96
Intervention | log10 c/mL (Median) |
---|
| Baseline (n=13,10,4,7,34) | Week 60 (n=7, 8, 3, 4, 22) | Week 72 (n=7, 6, 1, 3, 17) | Week 84 (n=7, 7, 2, 4, 20) | Week 96 (n=7, 6, 2, 4, 19) |
---|
EFV+ddI+FTC in All Participants | 5.88 | -3.50 | -3.45 | -3.37 | -3.45 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 5.88 | -3.26 | -3.20 | -2.18 | -2.15 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 5.50 | -3.48 | -4.18 | -3.51 | -3.57 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 5.88 | -3.92 | -4.08 | -4.08 | -3.82 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 5.88 | -3.44 | -2.75 | -3.28 | -3.73 |
[back to top]
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants
Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 24. (NCT00364793)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| CVR (n=15, 10, 4, 8, 37) | VR-OC (n=11, 10, 4, 7, 32) |
---|
EFV+ddI+FTC in All Participants | 15 | 16 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 3 | 2 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 4 | 4 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 4 | 5 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 4 | 5 |
[back to top]
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Week 48 as Analyzed by Different Algorithms - All Treated Participants
Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 50 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 50 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 50 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 50 c/mL in the predefined Week 48 visit window; denominator was all treated participants. (NCT00364793)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| CVR (NC=F) n=15, 10, 4, 8, 37 | VR-OC n=9, 9, 3, 6, 27 | SNAPSHOT n=15, 10, 4, 8, 37 |
---|
EFV+ddI+FTC in All Participants | 18 | 17 | 17 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 2 | 2 | 2 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 4 | 4 | 4 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 6 | 6 | 6 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 6 | 5 | 5 |
[back to top]
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Week 24 as Analyzed by Different Algorithms - All Treated Participants
Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 24; participants were failures if virologic rebound occurred at or before Week 24; therapy discontinued before Week 24; no response by Week 24, or missing HIV RNA at Week 24 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 24 visit and within the predefined Week 24 visit window; those on treatment and missing their Week 24 measurement were responders only if previous and subsequent measurements to the Week 24 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 24. (NCT00364793)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| CVR (n=15, 10, 4, 8, 37) | VR-OC(n=11,10 ,4, 7, 32) |
---|
EFV+ddI+FTC in All Participants | 26 | 25 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 4 | 4 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 7 | 6 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 8 | 8 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 7 | 7 |
[back to top]
The Number of Participants With Plasma HIV RNA < 400 Copies Per Milliliter (c/mL) at Week 48 as Analyzed by Different Algorithms - All Treated Participants
Algorithms: Confirmed Virologic Response (CVR) non-completer = failure (NC = F): participants were responders if they achieved confirmed HIV RNA < 400 c/mL at Week 48; participants were failures if virologic rebound occurred at or before Week 48; therapy discontinued before Week 48; no response by Week 48, or missing HIV RNA at Week 48 and beyond. Virologic Response - Observed Cases (VR-OC): participants were responders according to a single on-treatment HIV RNA < 400 c/mL closest to the planned Week 48 visit and within the predefined Week 48 visit window; those on treatment and missing their Week 48 measurement were responders only if previous and subsequent measurements to the Week 48 visit window were < 400 c/mL; denominator was all who remained on treatment through Week 48. Snapshot: participants were responders according to the last on-treatment HIV RNA < 400 c/mL in the predefined Week 48 visit window; denominator was all treated participants. (NCT00364793)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| CVR (NC=F) n=15, 10, 4, 8, 37 | VR-OC n=9, 9, 3, 6, 27 | SNAPSHOT n=15, 10, 4, 8, 37 |
---|
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 3 | 3 | 3 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 5 | 5 | 5 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 7 | 7 | 7 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 6 | 6 | 6 |
,Total Participants | 21 | 21 | 21 |
[back to top]
Percent of CD4 Cells Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants
A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 60, 72, 84, and 96
Intervention | percentage of CD4 cells (Median) |
---|
| Baseline (n=7,9,3,5,24) | Week 60 (n=3,6,2,3,14) | Week 72 (n=2,7,1,3,13) | Week 84 (n=3,7,1,3,14) | Week 96 (n=3,6,1,3,13) |
---|
EFV+ddI+FTC in All Participants | 24 | 7 | 1 | 7 | 7 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 12 | 7 | -1 | 2 | 15 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 7 | 13 | 12 | 12 | 14 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 28 | 10 | -14 | -3 | -2 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 26 | 3 | 1 | 8 | 7 |
[back to top]
Percent of CD4 Cells Change From Baseline at Weeks 24 and 48 - Treated Participants
A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeter to the third power (cells/mm^3). Percent of CD4 cells is the number of CD4 cells per total number of cells measured*100. An increase in the percent of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 24 and 48
Intervention | percentage of CD4 cells (Median) |
---|
| Baseline (n=7, 9, 3, 5, 24) | Week 24 (n=3, 7, 3, 5, 18) | Week 48 (n=5, 8, 2, 5, 20) |
---|
EFV+ddI+FTC in All Participants | 24 | 9 | 6 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 12 | 9 | 8 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 7 | 10 | 11 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 28 | 14 | 5 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 26 | 2 | 4 |
[back to top]
Number of Participants With Acquisition of Resistance to EFV Categorized by AUC Relationship - Evaluable Pharmacokinetic Population
PK parameters were evaluated 2 weeks post start of dosing. Based on observed AUC, measured in micromoles (μM)*h, dosing was increased, remained the same, or decreased at next visit to achieve the desired AUC (110-380 μM*h). Number of participants who became resistant was categorized by those who required additional dosing after Week 2 (AUC<110 μM*h) and those who did not. AUC: derived from plasma concentration of EFV versus time. Plasma concentrations for determination of AUC were obtained using a validated LC-MS/MS method. LLOQ for EFV = 10.0 ng/mL and ULOQ = 8,000 ng/mL. AUC calculated by log- and linear trapezoidal summations. Genotypic resistance=presence of substitutions in the RT gene and/or presence of mutations that confer resistance to entire nucleoside reverse transcriptase inhibitor class. Phenotypic resistance=EFV: > 3.3* IC50 of control strain. Assays: Monogram Biosciences Phenosense™ GT (EFV biologic cutoff=3) and VircoTYPE™ HIV-1 v 4.3.01( EFV biologic cutoff=3.3). (NCT00364793)
Timeframe: Baseline to Week 48
Intervention | participants (Number) |
---|
| Resistant; AUC<110 µM•h(n=2,7,2,3,14) | Resistant; AUC>=110 µM•h(n=10,3,2,4,19) |
---|
EFV+ddI+FTC in All Participants | 6 | 4 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 1 | 0 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 1 | 0 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 1 | 2 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 3 | 2 |
[back to top]
Number of Treated Participants With Resistance Associated Genotypic and Phenotypic Changes in Viruses - Participants With Virologic Failure, Lack of Suppression or Viral Load Rebound
At baseline, treatment-naïve screened by genotype; treatment-experienced screened by genotype and phenotype. Genotypic resistance: presence of substitutions in reverse transcriptase (RT) gene and/or presence of mutations that confer resistance to nucleoside reverse transcriptase inhibitor class. Phenotype resistance: FTC: > 3.1* the 50% inhibitory concentration (IC50) of the control strain; EFV: > 3.3* IC50 ; ddI: > 2.6*IC50. Virologic failure: <1 log10 decrease in HIV RNA from Week 16 on; confirmatory HIV RNA within 14-35 days; HIV RNA > 10,000 c/mL with prior value < 400 c/mL; confirmatory HIV RNA 14-35 days. Monogram Biosciences Phenosense™ assay ( EFV and FTC: biologic cutoffs=3 and 3.5, respectively; ddI: clinical cutoff: lower limit=1.39; upper limit = 2.2.); VircoTYPE™ HIV-1 v 4.3.01( EFV, FTC: biologic cutoffs=3.3 and 3.1, respectively;ddI: clinical cutoff: lower limit = 0.9; upper limit = 2.6. No genotypic/phenotypic changes in presence of virologic failure=no resistance. (NCT00364793)
Timeframe: Baseline to Week 48
Intervention | participants (Number) |
---|
| Lack of suppression with Changes (PP) | Viral Load Rebound with Changes(PP) | Viral Failure with Changes (outside 35 day limit) |
---|
EFV+ddI+FTC in All Participants | 3 | 2 | 5 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 0 | 0 | 1 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 0 | 0 | 1 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 2 | 1 | 0 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 1 | 1 | 3 |
[back to top]
Number of Participants With Serum Chemistry Abnormalities - Treated Participants
Central/local laboratory. DAIDS v 2004. Bicarbonate, low: Gr 1: 16 milliequivalents per liter (mEq/L) - < LLN; Gr 2: 11.0-15.9 mEq/L; Gr 3: 8.0-10.9 mEq/L; Gr 4: <8.0 mEq/L; calcium, high Gr 1: 10.6-11.5 mg/dL; Gr 2: 11.6-12.5 mg/dL; Gr 3 12.6-13.5 mg/dL; Gr 4: >13.5 mg/dL; calcium, low Gr1: 7.8-8.4 mg/dL; Gr2: 7.0-7.7 mg/dL; Gr3: 6.1-6.9 mg/dL; Gr 4: <6.1 mg/dL; creatinine Gr1: 1.1-1.3*ULN; Gr 2: 1.4-1.8*ULN; Gr 3: 1.9-3.4*ULN; Gr 4: >=3.5*ULN; lipase Gr 1: 1.1-1.5*ULN; Gr 2: 1.6-3.0*ULN; Gr 3: 3.1-5.0*ULN; Gr 4: >5.0*ULN; potassium high (low) Gr 1: 5.6-6.0 (3.0-3.4) mEq/L; Gr 2: 6.1-6.5 (2.5-2.9) mEq/L; Gr 3: 6.6-7.0 (2.0-2.4) mEq/L; Gr 4: >7.0 (<2.0) mEq/L; sodium, high (low) Gr 1: 146-150 (130-135) mEq/L; Gr 2: 151-154 (125-129) mEq/L; Gr 3: 155-159 (121-124) mEq/L; Gr 4: >=160 (<=120) mEq/L; uric acid Gr 1: 7.5-10.0 mg/dL; Gr 2: 10.1-12.0 mg/dL; Gr 3: 12.1-15.0 mg/dL; Gr 4: >15.0 mg/dL. Baseline within 50 days post screening, prior to start of study medication. (NCT00364793)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Bicarbonate, low (n=12, 10, 4, 7, 33) | Sodium, low (n=12, 10, 4, 7, 33) | Sodium High (n=12, 10, 4, 7, 33) | Uric Acid (n=12, 10, 4, 7, 33) | Calcium High (n= 12, 10, 4, 7, 33) | Calcium Low (n= 12, 10, 4, 7, 33) | Potassium High (n= 12, 10, 4, 7, 33) | Potassium Low (n= 12, 10, 4, 7, 33) | Lipase Total (n= 12, 10, 4, 7, 33) |
---|
EFV+ddI+FTC in All Participants | 28 | 15 | 3 | 2 | 3 | 6 | 9 | 3 | 3 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 4 | 2 | 0 | 1 | 0 | 1 | 0 | 1 | 0 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 5 | 4 | 1 | 0 | 1 | 1 | 0 | 1 | 2 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 10 | 5 | 1 | 0 | 0 | 0 | 5 | 1 | 1 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 9 | 4 | 1 | 1 | 2 | 4 | 4 | 0 | 0 |
[back to top]
[back to top]
Number of Participants With Liver Function Test Laboratory Abnormalities - Treated Population
Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. Division of AIDS Table (DAIDS) for Grading Severity of Adult and Pediatric AEs version (v) Dec 2004. Upper limit of normal (ULN): lower limit of normal (LLN), alanine transaminase (ALT); aspartate aminotransferase (AST); alkaline phosphatase (ALP). ALT Grade (Gr) 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. AST Gr 1: 1.25 to 2.5*ULN; Gr 2: 2.6 to 5.0*ULN; Gr 3: 5.1 to 10.0*ULN; Gr 4: >10.0*ULN. Total bilirubin Gr 1: 1.25 to 1.5*ULN; Gr 2: 1.6 to 2.5*ULN; Gr 3: 2.6 to 5.0*ULN; Gr 4: >5.0*ULN. ALP (U/L) Gr 1: 1.25 to 2.5*ULN, Gr 2: 2.6 to 5.0*ULN, Gr 3: 5.1 to 10.0*ULN, Gr 4: >10.0*ULN. Albumin (low) Gr 1: 3 grams per deciliter (g/dL) to NCT00364793)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Albumin (n=12, 10, 4, 7, 33) | ALP (n=12, 10, 4, 7, 33) | ALT (n=12, 10, 4, 7, 33) | AST (n=12, 10, 4, 7, 33) |
---|
EFV+ddI+FTC in All Participants | 1 | 17 | 12 | 10 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 1 | 2 | 2 | 1 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 0 | 5 | 0 | 0 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 0 | 8 | 7 | 8 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 0 | 2 | 3 | 1 |
[back to top]
CD4 Cell Count Change From Baseline at Weeks 60, 72, 84, and 96 - Treated Participants
A CD4 cell is an antigenic marker of helper/inducer T cells. These cells were counted during the hematology cell counts performed during a Complete Blood Cell count (CBC) performed by the Central Laboratory. CD4 are measured as number of cells per millimeters to the third power (cells/mm^3). An increase from baseline in the number of CD4 cells is an improvement. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline to Weeks 60, 72, 84, and 96
Intervention | cells/mm^3 (Median) |
---|
| Baseline (n=10,9,3,6,28) | Week 60 (n=6, 6, 2,3,17) | Week 72 (n=5, 7, 1, 3, 16) | Week 84 (n=6, 7, 1, 3, 17) | Week 96 (n=6, 6, 1, 3, 16) |
---|
EFV+ddI+FTC in All Participants | 1144 | -315 | 92 | 59 | -40 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 517 | 580 | -50 | 101 | 402 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 413 | 676 | 620 | 497 | 744 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 1518 | -870 | -1178 | -937 | -834 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 1569 | -914 | 234 | 59 | -43 |
[back to top]
Number of Participants With Lipid and Glucose Laboratory Abnormalities - Treated Participants
Abnormalities were determined from measurements analyzed at central or local laboratory. DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Total Cholesterol (fasting) Gr 1: 170 - 199 mg/dL; Gr 2: 200 - 300 mg/dL; Gr 3 >300 mg/dL; Gr 4 Not Applicable(NA). LDL cholesterol, fasting: Gr 1: 110-129 mg/dL; Gr 2: 130-189 mg/dL; Gr 3 >=190 mg/dL; Gr 4 NA. Triglycerides, fasting: Gr 1: NA; Gr 2 500-750 mg/dL; Gr 3: 751-1,200 mg/dL; Gr 4: >1,200 mg/dL. Glucose, serum, high, fasting and (non-fasting): Gr 1: 110 - 125 (116-160) mg/dL; Gr 2: 126-250 (161- 250) mg/dL; Gr 3: 251-500 (251-500) mg/dL; Gr 4: >500 (> 500) mg/dL. Glucose, serum, low, >=1 month of age (<1 month): Gr 1: 55-64 (50-54) mg/dL; Gr 2: 40-54 (40-49) mg/dL; Gr 3: 30-39 (30-39) mg/dL; Gr 4: <30 (<30) mg/dL. Baseline: within 50 days after the screening visit and was prior to start of study medication (Week 1). Only those in 4th arm were old enough to fast prior to testing; other arms did not have fasting samples taken. (NCT00364793)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Total Cholesterol (n=9,10,4,0,23) | Total Cholesterol Fasting (n=0,0,0,7,7) | Glucose High (n=11,10,3,0,24) | Glucose Low (n=11,10,3,0,24) | Glucose High Fasting (n=0,0,0,7,7) | LDL cholesterol (n=9,10,4,0,23) | LDL cholesterol fasting (n=0,0,0,7,7) |
---|
EFV+ddI+FTC in All Participants | 7 | 1 | 1 | 3 | 1 | 4 | 1 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 1 | NA | 0 | 0 | NA | 0 | NA |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | NA | 1 | NA | NA | 1 | NA | 1 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 2 | NA | 1 | 2 | NA | 0 | NA |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 4 | NA | 0 | 1 | NA | 4 | NA |
[back to top]
Number of Participants With Hematologic Abnormalities - Treated Participants
Abnormalities were determined from laboratory measurements analyzed at the central or local laboratory. DAIDS DAIDS Grading Severity of Adult and Pediatric AEs v Dec 2004. Hemoglobin Gr 1: 8.5-10.0 g/dL; Gr 2: 7.5-8.4 g/dL; Gr 3: 6.50-7.4 g/dL; Gr 4: <6.5 g/dL; Platelets, decreased: Gr 1: 100.000-124.999*10^9/L; Gr 2: 50.000-99.999*10^9/L; Gr 3: 25.000-49.999*10^9/L; Gr 4: <25.000*10^9/L; White blood cell count (WBC) decreased Gr 1: 2.000-2.500*10^9/L; Gr 2: 1.500-1.999*10^9/L; Gr 3: 1.000-1.499*10^9/L; Gr 4: <1.000*10^9/L. Baseline visit was within 50 days post screening and was prior to start of study drug (Week 1). (NCT00364793)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Hemoglobin (n=11, 10, 4, 7, 32) | Platelet (n=11, 10, 4, 7, 32) | Neutrophils (n=11, 10, 4, 7, 32) |
---|
EFV+ddI+FTC in All Participants | 12 | 2 | 10 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 2 | 0 | 0 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 1 | 0 | 1 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 4 | 1 | 7 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 5 | 1 | 2 |
[back to top]
Apparent Oral Clearance (CLT/F) of EFV at Week 2 - Pharmacokinetic Evaluable Population
Plasma concentrations of EFV were obtained using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. CLT/F was calculated by dividing the dose of EFV by AUC(TAU) of EFV. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. CLT/F was measured in liters per hour (L/h). (NCT00364793)
Timeframe: Week 2
Intervention | L/h (Geometric Mean) |
---|
EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 9.54 |
EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 19.69 |
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 13.16 |
EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 9.11 |
[back to top]
Maximum Observed Plasma Concentration (Cmax) and Plasma Concentration 24 Hours Post-dose (Cmin) of EFV at Week 2 - Pharmacokinetic Evaluable Population
Cmax and Cmin were derived from plasma concentrations versus time using a validated liquid chromatography tandem mass spectrometry method (LC-MS/MS). The lower limit of quantification (LLOQ) for EFV was 10.0 nanograms per milliliter (ng/mL) and the upper limit of quantification (ULOQ) was 8,000 ng/mL. Cmax and Cmin were recorded directly from experimental observations. Blood samples were collected before study drug administration and at 0.5, 1, 3, 5, 8, and 24 hours after study drug administration from an indwelling catheter or by direct venipuncture and the pharmacokinetic parameters were summarized using geometric means. Cmax and Cmin were measured in ng/mL. (NCT00364793)
Timeframe: Week 2
Intervention | ng/mL (Geometric Mean) |
---|
| Cmax | Cmin |
---|
EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 2167 | 648 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 2632 | 1185 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 3790 | 391 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 1998 | 445 |
[back to top]
The Number of Participants With Plasma HIV RNA Levels < 400 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants
Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 400 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 400 c/mL; denominator was all who remained on treatment through the specific week. (NCT00364793)
Timeframe: Weeks 60, 72, 84, and 96
Intervention | participants (Number) |
---|
| Week 60 (n=7, 8, 3, 4, 22) | Week 72 (n=7, 7, 2, 4, 20) | Week 84 (n=7, 7, 2, 4, 20) | Week 96 (n=7, 6, 2, 4, 19) |
---|
EFV+ddI+FTC in All Participants | 19 | 17 | 17 | 17 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 2 | 1 | 1 | 1 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 4 | 4 | 4 | 4 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 7 | 7 | 7 | 7 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 6 | 5 | 5 | 5 |
[back to top]
Log10 c/mL HIV RNA Changes From Baseline Through Week 48 - Treated Participants
HIV RNA measured as log10 copies per milliliter (c/mL) plasma. HIV RNA values ≥ 1,000 c/mL were considered evidence of infection. A decrease in number of c/mL is an improvement for the participant. HIV RNA was first measured using the ultrasensitive and standard Roche Amplicor PCR, version 1.5, and then the method of measurement was switched to the COBAS AmpliPrep/COBAS TaqMan HIV IVD method. The Baseline visit was within 50 days after the screening visit and was prior to start of study medication (Week 1). (NCT00364793)
Timeframe: Baseline through Week 48
Intervention | log10 c/mL (Median) |
---|
| Baseline (n=13,10,4,7,34) | Week 2 (n=12, 9, 4, 5, 30) | Week 4 (n=11, 8, 4, 6, 29) | Week 8 (n=11, 10, 3, 7, 31) | Week 12 (n=10, 10, 3, 6, 29) | Week 16 (n=10, 10, 4, 7, 31) | Week 24 (n=10, 9, 3, 7, 29) | Week 32 (n=9, 9, 4, 6, 28) | Week 40 (n=7, 9, 4 ,6, 26) | Week 48 (n=9, 9, 3, 6, 27) |
---|
EFV+ddI+FTC in All Participants | 5.88 | -2.11 | -2.63 | -2.92 | -3.14 | -3.27 | -3.28 | -3.27 | -3.93 | -3.18 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 5.88 | -2.42 | -2.86 | -2.92 | -4.02 | -4.11 | -4.18 | -3.73 | -4.02 | -3.27 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 5.50 | -1.93 | -3.04 | -3.27 | -3.31 | -3.44 | -2.95 | -2.93 | -2.93 | -2.93 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 5.88 | -1.89 | -2.18 | -2.73 | -2.48 | -2.72 | -3.46 | -2.75 | -4.01 | -2.92 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 5.88 | -2.26 | -2.49 | -2.91 | -3.19 | -3.17 | -3.92 | -3.28 | -4.17 | -3.27 |
[back to top]
The Number of Participants With Plasma HIV RNA Levels < 50 c/mL at Weeks 60, 72, 84 and 96 (Observed Cases) - All Treated Participants
Virologic Response - Observed Cases (VR-OC): participants were responders at a specific week according to a single on-treatment HIV RNA < 50 c/mL closest to the planned visit and within the predefined visit window; those on treatment and missing their specific week measurement were responders only if previous and subsequent measurements to that week visit window were < 50 c/mL; denominator was all who remained on treatment through the specific week. (NCT00364793)
Timeframe: Weeks 60, 72, 84, and 96
Intervention | participants (Number) |
---|
| Week 60 (n=7, 8, 3, 4, 22) | Week 72 (n=7, 7, 2, 4, 20) | Week 84 (n=7, 7, 2, 4, 20) | Week 96 (n=7, 6, 2, 4, 19) |
---|
EFV+ddI+FTC in All Participants | 14 | 17 | 16 | 15 |
,EFV+ddI+FTC in Children >= 2 Years to < 3 Years | 2 | 1 | 1 | 0 |
,EFV+ddI+FTC in Children >= 3 Years to <= 6 Years | 3 | 4 | 3 | 4 |
,EFV+ddI+FTC in Infants >=3 Months to < 6 Months | 4 | 7 | 7 | 6 |
,EFV+ddI+FTC in Infants >=6 Months to < 2 Years | 5 | 5 | 5 | 5 |
[back to top]
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 272 | 10 |
,MK-0518 400 mg b.i.d. | 253 | 28 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 41 | 241 |
,MK-0518 400 mg b.i.d. | 27 | 254 |
[back to top]
Number of Participants With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 63 | 219 |
,MK-0518 400 mg b.i.d. | 41 | 240 |
[back to top]
Number of Participants With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 77 | 205 |
,MK-0518 400 mg b.i.d. | 56 | 225 |
[back to top]
Number of Participants With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| With LAEs | Without LAEs |
---|
Efavirenz 600 mg q.h.s. | 53 | 229 |
,MK-0518 400 mg b.i.d. | 33 | 248 |
[back to top]
Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression (NCT00369941)
Timeframe: 8 Weeks
Intervention | Participants (Number) |
---|
| With Nervous System Symptoms | Without Nervous System Symptoms |
---|
Efavirenz 600 mg q.h.s. | 147 | 135 |
,MK-0518 400 mg b.i.d. | 57 | 224 |
[back to top]
Number of Participants With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| With Serious CAEs | Without Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 46 | 236 |
,MK-0518 400 mg b.i.d. | 46 | 235 |
[back to top]
Number of Participants With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| With Serious CAEs | Without Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 57 | 225 |
,MK-0518 400 mg b.i.d. | 57 | 224 |
[back to top]
Number of Participants With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| With Serious CAEs | Without Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 27 | 255 |
,MK-0518 400 mg b.i.d. | 28 | 253 |
[back to top]
Number of Participants With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| With Serious CAEs | Without Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 33 | 249 |
,MK-0518 400 mg b.i.d. | 37 | 244 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Number of Participants With Serious LAEs at Week 156
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| With Serious LAEs | Without Serious LAEs |
---|
Efavirenz 600 mg q.h.s. | 2 | 280 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
Number of Participants With Serious LAEs at Week 240
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| With Serious LAEs | Without Serious LAEs |
---|
Efavirenz 600 mg q.h.s. | 2 | 280 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
Number of Participants With Serious LAEs at Week 96
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| With Serious LAEs | Without Serious LAEs |
---|
Efavirenz 600 mg q.h.s. | 1 | 281 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 224 |
Efavirenz 600 mg q.h.s. | 203 |
[back to top]
Change From Baseline in CD4 Cell Count at Week 156
Mean change from baseline at Week 156 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 156
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 331.7 |
Efavirenz 600 mg q.h.s. | 295.2 |
[back to top]
Change From Baseline in CD4 Cell Count at Week 240
Mean change from baseline at Week 240 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 240
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 373.7 |
Efavirenz 600 mg q.h.s. | 311.6 |
[back to top]
Change From Baseline in CD4 Cell Count at Week 96
Mean change from baseline at Week 96 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 96
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 239.6 |
Efavirenz 600 mg q.h.s. | 224.8 |
[back to top]
Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
Mean change from baseline at Week 48 in CD4 cell count (cells/mm3) (NCT00369941)
Timeframe: Baseline and Week 48
Intervention | CD4 Cell Count (cells/mm3) (Mean) |
---|
MK-0518 400 mg b.i.d. | 189.1 |
Efavirenz 600 mg q.h.s. | 163.3 |
[back to top]
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 206 |
Efavirenz 600 mg q.h.s. | 181 |
[back to top]
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 252 |
Efavirenz 600 mg q.h.s. | 241 |
[back to top]
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 240 |
Efavirenz 600 mg q.h.s. | 229 |
[back to top]
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 212 |
Efavirenz 600 mg q.h.s. | 192 |
[back to top]
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 198 |
Efavirenz 600 mg q.h.s. | 171 |
[back to top]
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 228 |
Efavirenz 600 mg q.h.s. | 222 |
[back to top]
Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
MK-0518 400 mg b.i.d. | 241 |
Efavirenz 600 mg q.h.s. | 230 |
[back to top]
Number of Participants With Serious LAEs at Week 48
"A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.~Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose." (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| With Serious LAEs | Without Serious LAEs |
---|
Efavirenz 600 mg q.h.s. | 1 | 281 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Number of Participants Discontinued With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With LAEs | Did Not Discontinue With LAEs |
---|
Efavirenz 600 mg q.h.s. | 3 | 279 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
Number of Participants Discontinued With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With LAEs | Did Not Discontinue With LAEs |
---|
Efavirenz 600 mg q.h.s. | 3 | 279 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
Number of Participants Discontinued With LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| Discontinued with LAEs | Did Not Discontinue with LAEs |
---|
Efavirenz 600 mg q.h.s. | 1 | 281 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
Number of Participants Discontinued With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With LAEs | Did Not Discontinue With LAEs |
---|
Efavirenz 600 mg q.h.s. | 2 | 280 |
,MK-0518 400 mg b.i.d. | 0 | 281 |
[back to top]
Number of Participants That Died by Week 156
All participant deaths in the span of 156 weeks on study were recorded. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 1 | 281 |
,MK-0518 400 mg b.i.d. | 4 | 277 |
[back to top]
Number of Participants That Died by Week 240
All participant deaths in the span of 240 weeks on study were recorded. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 5 | 277 |
,MK-0518 400 mg b.i.d. | 5 | 276 |
[back to top]
Number of Participants That Died by Week 48
All participant deaths in the span of 48 weeks on study were recorded. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 0 | 282 |
,MK-0518 400 mg b.i.d. | 2 | 279 |
[back to top]
Number of Participants That Died by Week 96
All participant deaths in the span of 96 weeks on study were recorded. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| Died | Did Not Die |
---|
Efavirenz 600 mg q.h.s. | 0 | 282 |
,MK-0518 400 mg b.i.d. | 3 | 278 |
[back to top]
Number of Participants That Discontinued With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With CAEs | Did Not Discontinue With CAEs |
---|
Efavirenz 600 mg q.h.s. | 21 | 261 |
,MK-0518 400 mg b.i.d. | 13 | 268 |
[back to top]
Number of Participants That Discontinued With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With CAEs | Did Not Discontinue With CAEs |
---|
Efavirenz 600 mg q.h.s. | 25 | 257 |
,MK-0518 400 mg b.i.d. | 14 | 267 |
[back to top]
Number of Participants That Discontinued With CAEs at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| Discontinued with CAEs | Did Not Discontinue with CAEs |
---|
Efavirenz 600 mg q.h.s. | 17 | 265 |
,MK-0518 400 mg b.i.d. | 9 | 272 |
[back to top]
Number of Participants That Discontinued With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With CAEs | Did Not Discontinue With CAEs |
---|
Efavirenz 600 mg q.h.s. | 17 | 265 |
,MK-0518 400 mg b.i.d. | 10 | 271 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Number of Participants That Discontinued With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With Serious CAEs | Did Not Discontinue With Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 6 | 276 |
,MK-0518 400 mg b.i.d. | 10 | 271 |
[back to top]
Number of Participants That Discontinued With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With Serious CAEs | Did Not Discontinue With Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 10 | 272 |
,MK-0518 400 mg b.i.d. | 11 | 270 |
[back to top]
Number of Participants That Discontinued With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 48 Weeks
Intervention | Participants (Number) |
---|
| Discontinued with Serious CAEs | Did Not Discontinue with Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 4 | 278 |
,MK-0518 400 mg b.i.d. | 7 | 274 |
[back to top]
Number of Participants That Discontinued With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| Discontinued With Serious CAEs | Did Not Discontinue With Serious CAEs |
---|
Efavirenz 600 mg q.h.s. | 5 | 277 |
,MK-0518 400 mg b.i.d. | 8 | 273 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Number of Participants With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 156 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 276 | 6 |
,MK-0518 400 mg b.i.d. | 267 | 14 |
[back to top]
Number of Participants With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 240 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 276 | 6 |
,MK-0518 400 mg b.i.d. | 271 | 10 |
[back to top]
Number of Participants With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. (NCT00369941)
Timeframe: 96 Weeks
Intervention | Participants (Number) |
---|
| With CAEs | Without CAEs |
---|
Efavirenz 600 mg q.h.s. | 274 | 8 |
,MK-0518 400 mg b.i.d. | 265 | 16 |
[back to top]
Number of Participants Experiencing Either an AIDS-defining Event, a Grade 3 or 4 Adverse Event, or Acute Retroviral Syndrome
(NCT00414518)
Timeframe: At Week 24
Intervention | participants (Number) |
---|
Arm A | 1 |
Arm B | 1 |
[back to top]
Plasma HIV-1 Viral Load (Copies/ml) at Week 24 as Compared Between the Two Arms
(NCT00414518)
Timeframe: At Week 24
Intervention | Log 10 copies of virus/ml (Mean) |
---|
12 Week Treatment Arm Followed by Treatment Interruption | 4.8627 |
CD4 T Cell Guided Therapyh | 4.2620 |
[back to top]
Viral Set Point
set point is reached after the immune system has developed HIV antibodies and begins to attempt to fight the virus (NCT00414518)
Timeframe: Throughout study
Intervention | Log 10 copies virus/ml (Mean) |
---|
12 Week Treatment Folllowed by Treatment Interruption | 4.8627 |
CD4 T Cell Guided Therapy | 4.2434 |
[back to top]
Time to First Safety Event
Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. (NCT00442962)
Timeframe: Throughout study
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 15th percentile |
---|
EFV + FTC/TDF | 4.1 | 24.4 | 33.1 |
[back to top]
Late Change in CD4 Count From Baseline
Change in CD4+ lymphocyte counts between week 48 study visit and baseline. (NCT00442962)
Timeframe: At week 48
Intervention | cells/mm^3 (Mean) |
---|
EFV + FTC/TDF | 194 |
[back to top]
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)
(NCT00442962)
Timeframe: Throughout study
Intervention | weeks (Number) |
---|
| 10th percentile | 15th percentile | 20th percentile |
---|
EFV + FTC/TDF | 16 | 24 | 24 |
[back to top]
Percentage of Participants With Early Virologic Suppression
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml (NCT00442962)
Timeframe: At Weeks 24
Intervention | percentage of participants (Number) |
---|
EFV + FTC/TDF | 72.0 |
[back to top]
Percentage of Participants With Early Virologic Response
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NCT00442962)
Timeframe: At Week 24
Intervention | percentage of participants (Number) |
---|
EFV + FTC/TDF | 80.8 |
[back to top]
Time to Initial Virological Failure
Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment. (NCT00442962)
Timeframe: Throughout study
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile | 15th percentile |
---|
EFV + FTC/TDF | 16 | 16 | 24 |
[back to top]
Time to Initial Virologic Response
Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL. (NCT00442962)
Timeframe: Throughout study
Intervention | weeks (Number) |
---|
| 50th percentile | 75th percentile | 95th percentile |
---|
EFV + FTC/TDF | 2 | 8 | 24 |
[back to top]
Time to First Dose Modification
Time from starting study treatment to first dose/drug modification. (NCT00442962)
Timeframe: Throughout study
Intervention | weeks (Number) |
---|
| 10th percentile | 15th percentile | 20th percentile |
---|
EFV + FTC/TDF | 1.9 | 24.9 | 25.7 |
[back to top]
Early Changes in CD4 Count From Baseline
Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline. (NCT00442962)
Timeframe: At weeks 0(baseline), 4, 8, 16, 24
Intervention | cells/mm^3 (Mean) |
---|
| Change from baseline to week 4 | Change from baseline to week 8 | Change from baseline to week 16 | Change from baseline to week 24 |
---|
EFV + FTC/TDF | 105 | 118 | 138 | 147 |
[back to top]
Percentage of Participants With Late Virologic Suppression
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml (NCT00442962)
Timeframe: At Week 48
Intervention | percentage (Number) |
---|
EFV + FTC/TDF | 70.5 |
[back to top]
Percentage of Participants With Late Virologic Response
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NCT00442962)
Timeframe: At Week 48
Intervention | percentage (Number) |
---|
EFV + FTC/TDF | 80.43 |
[back to top]
Antiretroviral (ARV) Resistance Patterns in Seroconverters
Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations. (NCT00448669)
Timeframe: At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis
Intervention | Participants (Count of Participants) |
---|
TDF-FTC, Condoms, Risk Counseling | 1 |
Placebo, Condoms, Risk Counseling | 1 |
[back to top]
CD4 Evaluation After HIV Seroconversion
Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated. (NCT00448669)
Timeframe: 1-year post seroconversion
Intervention | cells/microliter (Geometric Mean) |
---|
TDF-FTC Seroconvertor Group | 500 |
Placebo Seroconvertor Group | 466 |
[back to top]
HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms
Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort). (NCT00448669)
Timeframe: Monthly, for up to 3 years
Intervention | infections/100 person-years (Number) |
---|
TDF-FTC, Condoms, Risk Counseling | 1.2 |
Placebo, Condoms, Risk Counseling | 3.1 |
[back to top]
Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms
Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits. (NCT00448669)
Timeframe: Monthly, for up to 3 years
Intervention | percentage of participants with AE (Number) |
---|
TDF-FTC, Condoms, Risk Counseling | 91.2 |
Placebo, Condoms, Risk Counseling | 88.2 |
[back to top]
Rates of Adherence to Study Medication
The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test. (NCT00448669)
Timeframe: 36 months
Intervention | Percentage of pills taken (Mean) |
---|
TDF-FTC, Condoms, Risk Counseling | 93.5 |
Placebo, Condoms, Risk Counseling | 93.6 |
[back to top]
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts
We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment. (NCT00448669)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
| Baseline | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 7 | Month 8 | Month 9 | Month 10 | Month 11 | Month 12 |
---|
Placebo, Condoms, Risk Counseling | 113 | 86 | 90 | 83 | 66 | 61 | 67 | 45 | 49 | 45 | 36 | 33 | 30 |
,TDF-FTC, Condoms, Risk Counseling | 124 | 94 | 97 | 92 | 73 | 67 | 70 | 55 | 57 | 55 | 51 | 36 | 54 |
[back to top]
Number of Subjects With Hepatitis b Virus (HBV) DNA <1000 IU/ml at Week 48
Number of subjects whose serum HBV DNA level was <1000 IU/ml at Week 48 (NCT00524173)
Timeframe: At Week 48
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 11 |
Tenofovir & Emtricitabine | 13 |
[back to top]
Number of Participants With HBV DNA <1000 IU/ml at Week 192
Number of participants whose serum HBV DNA level was <1000 IU/ml at Week 192 (NCT00524173)
Timeframe: At Week 192
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 12 |
Tenofovir & Emtricitabine | 12 |
[back to top]
Number of Participants With Loss of HBsAg
The number of participants whose serum hepatitis B surface antigen was no longer detectable. (NCT00524173)
Timeframe: 192 weeks
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 1 |
Tenofovir & Emtricitabine | 0 |
[back to top]
Number of Participants With Normalized Alanine Aminotransferase (ALT)
Number of participants whose serum ALT levels were measured within normal limits. (NCT00524173)
Timeframe: 192 weeks
Intervention | Participants (Count of Participants) |
---|
Tenofovir Only | 8 |
Tenofovir & Emtricitabine | 13 |
[back to top]
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 24
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 24
Intervention | participants (Number) |
---|
| Any event | Drug hypersensitivity | Rash | Dizziness | Hypersensitivity | Drug eruption |
---|
ABC/3TC FDC | 26 | 11 | 2 | 0 | 3 | 1 |
,TDF/FTC FDC | 14 | 1 | 3 | 2 | 0 | 1 |
[back to top]
Number of Participants Classified as Protocol-defined Failures With Treatment-emergent Resistance to Study Drug in the Indicated Viruses at Week 96
Viral resistance was measured using blood samples collected from participants throughout the study. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor. Virological failure was defined as any one of: participant does not achieve a 1 log10 copies (cop)/mL decrease in plasma HIV-1 RNA by Week (Wk) 4, or has two consecutive plasma HIV-1 RNA measures >=400 cop/mL separated by at least 2-4 wk after being previously <=400 cop/mL on/after Wk 4, or has two consecutive plasma HIV-1 RNA measures >400 cop/mL separated by at least 2-4 wk on/after Wk 24. (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Any treatment-emergent mutation | NRTI | NNRTI |
---|
ABC/3TC FDC | 4 | 4 | 2 |
,TDF/FTC FDC | 0 | 0 | 0 |
[back to top]
"Number of Participants Who Indicated Yes or No to the Question of Whether Unplanned Healthcare Resources Were Utilized"
Participants were asked at each visit whether or not they utilized unplanned healthcare resources. (NCT00549198)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Week 4, Yes, n=178, 183 | Week 4, No, n=178, 183 | Week 12, Yes, n=162, 177 | Week 12, No, n=162, 177 | Week 24, Yes, n=156, 173 | Week 24, No, n=156, 173 | Week 36, Yes, n=148, 169 | Week 36, No, n=148, 169 | Week 48, Yes, n=137, 161 | Week 48, No, n=137, 161 | Week 60, Yes, n=129, 148 | Week 60, No, n=129, 148 | Week 72, Yes, n=126, 139 | Week 72, No, n=126, 139 | Week 84, Yes, n=121, 136 | Week 84, No, n=121, 136 | Week 96, Yes, n=113, 135 | Week 96, No, n=113, 135 |
---|
ABC/3TC FDC | 60 | 118 | 56 | 106 | 70 | 86 | 48 | 100 | 44 | 93 | 47 | 82 | 48 | 78 | 34 | 87 | 30 | 83 |
,TDF/FTC FDC | 49 | 134 | 47 | 130 | 59 | 114 | 50 | 119 | 36 | 125 | 44 | 104 | 40 | 99 | 24 | 108 | 17 | 118 |
[back to top]
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -0.87 |
TDF/FTC FDC | -1.70 |
[back to top]
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -1.59 |
TDF/FTC FDC | -2.41 |
[back to top]
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
BMD is a measure (grams [g] per centimeters cubed [cm^3]) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -2.12 |
TDF/FTC FDC | -3.30 |
[back to top]
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 96
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -2.17 |
TDF/FTC FDC | -3.55 |
[back to top]
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 48
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -1.90 |
TDF/FTC FDC | -3.56 |
[back to top]
Percent Change From Baseline in Hip Bone Mineral Density (BMD), Measured by Dual-energy X-ray Absorptiometry (DXA), at Week 24
BMD is a measure (grams per cm^3) of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. The standard error (SE) of both treatment groups was based on the model on the log scale. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | percent change (Mean) |
---|
ABC/3TC FDC | -1.19 |
TDF/FTC FDC | -2.73 |
[back to top]
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^s, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | mL/min/1.73m^2 (Mean) |
---|
ABC/3TC FDC | 1.48 |
TDF/FTC FDC | -1.15 |
[back to top]
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | mL/min/1.73m^2 (Mean) |
---|
ABC/3TC FDC | 2.78 |
TDF/FTC FDC | 0.43 |
[back to top]
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 96
Change from baseline was calculated as the Week 96 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | mL/min (Mean) |
---|
ABC/3TC FDC | 4.37 |
TDF/FTC FDC | 2.68 |
[back to top]
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | mL/min (Mean) |
---|
ABC/3TC FDC | 2.66 |
TDF/FTC FDC | 3.80 |
[back to top]
Mean Change From Baseline in Estimated GFR, Calculated by Cockcroft-Gault Equation, at Week 24
Change from baseline was calculated as the Week 24 value minus the baseline value. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. GFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. mg, milligram; dL, deciliter; kg, kilogram; CG, Cockcroft-Gault. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | mL/min (Mean) |
---|
ABC/3TC FDC | 4.27 |
TDF/FTC FDC | 2.54 |
[back to top]
Exploratory Analysis of Change From Baseline in Type 1 Collagen Cross-linked C-telopeptide at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | nanograms per Liter (ng/L) (Geometric Mean) |
---|
ABC/3TC FDC | 89.9 |
TDF/FTC FDC | 203.6 |
[back to top]
Exploratory Analysis of Change From Baseline in Retinol Binding Protein (RBP) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline RBP value by the urine creatinine value. RBP, retinol binding protein (measured in micrograms per millimole [ug/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 1.099 |
TDF/FTC FDC | 1.550 |
[back to top]
Exploratory Analysis of Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) at Week 96
P1NP is a bone biomarker that was analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | micrograms per Liter (ug/L) (Geometric Mean) |
---|
ABC/3TC FDC | 1.2 |
TDF/FTC FDC | 1.4 |
[back to top]
Mean Change From Baseline in Estimated Glomerular Filtration Rate (GFR), Calculated by Modification of Diet in Renal Disease (MDRD) Equation, at Week 48
Change from baseline was calculated as the Week 48 value minus the baseline value. GFR is a measure of the rate at which blood is filtered by the kidney. MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. GFR (mL/min/1.73 m^2) = 175 * (Scr)^-1.154 * (Age)^-0.203 * (0.742 if female) * (1.212 if African American) (conventional units). mL, milliliters; min, minute; m^2, meters squared; Scr, serum creatinine; BMI, body mass index. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | milliliters per minute (mL/min)/1.73 m^2 (Mean) |
---|
ABC/3TC FDC | 0.22 |
TDF/FTC FDC | 1.18 |
[back to top]
Exploratory Analysis of Change From Baseline in N-acetyl-B-glucosaminidase (NAG) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline NAG value by the urine creatinine value. NAG, N-acetyl-B-glucosaminidase (measured in micromoles per hour per millimole [umol/h/mmol]). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 0.868 |
TDF/FTC FDC | 0.939 |
[back to top]
Exploratory Analysis of Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ug/L (Geometric Mean) |
---|
ABC/3TC FDC | 1.111 |
TDF/FTC FDC | 2.542 |
[back to top]
Exploratory Analysis of Change From Baseline in Beta 2 Microglobulin (B2M) as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline B2M value by the urine creatinine value. B2M, beta 2 microglobulin (measured in mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 0.542 |
TDF/FTC FDC | 0.984 |
[back to top]
Exploratory Analysis of Change From Baseline in Albumin as a Ratio to Urine Creatinine at Week 96
Renal biomarkers were analyzed using urine samples collected from participants at baseline and Week 96. Renal biomarkers may be an indicator of various aspects of kidney function. The ratio was calculated by dividing the change from baseline albumin value by the urine creatinine value. Albumin is measured in milligrams per millimole (mg/mmol). (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ratio (Geometric Mean) |
---|
ABC/3TC FDC | 0.872 |
TDF/FTC FDC | 0.973 |
[back to top]
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 96
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | cells/mm^3 (Median) |
---|
ABC/3TC FDC | 235.0 |
TDF/FTC FDC | 220.0 |
[back to top]
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 48
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | cells/mm^3 (Median) |
---|
ABC/3TC FDC | 150.0 |
TDF/FTC FDC | 150.0 |
[back to top]
Change From Baseline in Cluster Difference 4 (CD4+) Cell Count at Week 24
CD4+ counts are used to monitor the progression of HIV disease and the strength of the immune system. The number of CD4+ cells decreases as HIV disease progresses. Cell counts were measured from participant blood samples taken throughout the study. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | cells/millimeters cubed (mm^3) (Median) |
---|
ABC/3TC FDC | 110.0 |
TDF/FTC FDC | 100.0 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Low to low | Low to normal | Low to high | Normal to low | Normal to normal | Normal to high | High to low | High to normal | High to high |
---|
ABC/3TC FDC | 17 | 67 | 18 | 0 | 11 | 27 | 0 | 0 | 10 |
,TDF/FTC FDC | 28 | 73 | 10 | 0 | 23 | 20 | 0 | 3 | 5 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Low to low | Low to normal | Low to high | Normal to low | Normal to normal | Normal to high | High to low | High to normal | High to high |
---|
ABC/3TC FDC | 19 | 72 | 10 | 0 | 12 | 26 | 0 | 0 | 10 |
,TDF/FTC FDC | 36 | 66 | 9 | 1 | 30 | 12 | 0 | 3 | 5 |
[back to top]
Exploratory Analysis of Change From Baseline in Osteocalcin at Week 96
Bone biomarkers were analyzed using blood samples collected from participants at baseline and Week 96. Bone biomarkers may be an indicator of bone turnover. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | ug/L (Geometric Mean) |
---|
ABC/3TC FDC | 3.01 |
TDF/FTC FDC | 5.79 |
[back to top]
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 96
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Missing | Normal | Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 |
---|
ABC/3TC FDC | 11 | 75 | 3 | 4 | 0 | 0 | 0 |
,TDF/FTC FDC | 18 | 83 | 4 | 4 | 0 | 0 | 0 |
[back to top]
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 48
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Missing | Normal | Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 |
---|
ABC/3TC FDC | 12 | 90 | 7 | 3 | 0 | 0 | 0 |
,TDF/FTC FDC | 19 | 106 | 5 | 3 | 0 | 0 | 0 |
[back to top]
Number of Participants With National Kidney Foundation Chronic Kidney Disease Stage 1, 2, 3, 4, or 5 Categories of Renal Function at Week 24
Normal: GFR >=60 mL/min/1.73 m^2 and creatinine ratio <=200 mg/g GFR; Stage 1: GFR >=90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 2: GFR >=60-<90 mL/min/1.73 m^2 and creatinine ratio >200 mg/g; Stage 3: GFR >=30-<60 mL/min/1.73 m^2; Stage 4: GFR >=15-<30 mL/min/1.73 m^2; Stage 5: GFR <15 mL/min/1.73 m^2. mL, milliliter; min, minute; m^2, meters squared; mg, milligram; g, gram. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Normal | Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 |
---|
ABC/3TC FDC | 97 | 11 | 5 | 1 | 0 | 0 |
,TDF/FTC FDC | 114 | 15 | 5 | 1 | 0 | 0 |
[back to top]
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 96
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| <50 copies/mL | <400 copies/mL |
---|
ABC/3TC FDC | 98 | 110 |
,TDF/FTC FDC | 113 | 126 |
[back to top]
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 48
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| <50 copies/mL | <400 copies/mL |
---|
ABC/3TC FDC | 121 | 130 |
,TDF/FTC FDC | 145 | 151 |
[back to top]
Number of Participants With HIV-1 RNA <50 Copies/Milliliter (c/mL) and 400 c/mL at Week 24
HIV-1 RNA level (viral load) is a strong predictor of the rate of HIV disease progression. It was measured from plasma (participant blood samples) taken at all visits throughout the study. HIV, human immunodeficiency virus; RNA, ribonucleic acid. Viral load is a measure of the severity of the HIV infection. (NCT00549198)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| <50 copies/mL | <400 copies/mL |
---|
ABC/3TC FDC | 126 | 147 |
,TDF/FTC FDC | 144 | 168 |
[back to top]
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 96
mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| >=10 mL/min, MDRD | >=10 mL/min, Cockcroft-Gault | >=20 mL/min, MDRD | >=20 mL/min, Cockcroft-Gault | >=10%, MDRD | >=10%, Cockcroft-Gault | >=20%, MDRD | >=20%, Cockcroft-Gault |
---|
ABC/3TC FDC | 15 | 11 | 4 | 4 | 15 | 12 | 3 | 3 |
,TDF/FTC FDC | 38 | 19 | 7 | 5 | 27 | 16 | 6 | 4 |
[back to top]
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 96
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug therapy. (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Cholesterol, Grade 3 | Cholesterol, Grade 4 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Non-HDL cholesterol, Grade 3 | Non-HDL cholesterol, Grade 4 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Total bilirubin, Grade 3 | Total bilirubin, Grade 4 | Creatinine kinase, Grade 3 | Creatinine kinase, Grade 4 | Phosphorus inorganic, Grade 3 | Phosphorus inorganic, Grade 4 | Lipase, Grade 3 | Lipase, Grade 4 | Hyperkalaemia, Grade 3 | Hyperkalaemia, Grade 4 | Glomerular filtration rate, MDRD, Grade 3 | Glomerular filtration rate, MDRD, Grade 4 | Total neutrophils, Grade 3 | Total neutrophils, Grade 4 | Thrombocytopenia, Grade 3 | Thrombocytopenia, Grade 4 |
---|
ABC/3TC FDC | 9 | 0 | 13 | 0 | 22 | 0 | 2 | 1 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 4 | 0 | 6 | 4 | 0 | 2 | 1 | 0 | 3 | 5 | 1 | 0 |
,TDF/FTC FDC | 1 | 0 | 5 | 0 | 5 | 0 | 0 | 0 | 4 | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 2 | 2 | 3 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 1 | 3 | 0 | 0 |
[back to top]
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 48
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| Cholesterol, Grade 3 | Cholesterol, Grade 4 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Non-HDL cholesterol, Grade 3 | Non-HDL cholesterol, Grade 4 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Total bilirubin Grade 3 | Total bilirubin, Grade 4 | Creatinine kinase, Grade 3 | Creatinine kinase, Grade 4 | Phosphorus inorganic, Grade 3 | Phosphorus inorganic, Grade 4 | Lipase, Grade 3 | Lipase, Grade 4 | Hyperkalaemia, Grade 3 | Hyperkalaemia, Grade 4 | Glomerular filtration rate, MDRD, Grade 3 | Glomerular filtration rate, MDRD, Grade 4 | Total neutrophils, Grade 3 | Total neutrophils, Grade 4 | Thrombocytopenia, Grade 4 |
---|
ABC/3TC FDC | 7 | 0 | 9 | 0 | 20 | 0 | 3 | 0 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 3 | 0 | 5 | 2 | 0 | 2 | 1 | 0 | 2 | 3 | 1 | 0 |
,TDF/FTC FDC | 1 | 0 | 3 | 0 | 6 | 0 | 0 | 0 | 4 | 1 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 1 | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 0 | 0 |
[back to top]
Number of Participants With the Indicated Treatment-emergent Division of AIDS (DAIDS) Toxicities at Week 24
The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening. LDL, low-density lipid; HDL, high-density lipid. Treatment emergent refers to any toxicity that was not present prior to the start of study drug treatment. (NCT00549198)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Cholesterol, Grade 3 | Cholesterol, Grade 4 | LDL cholesterol, Grade 3 | LDL cholesterol, Grade 4 | Non-HDL cholesterol, Grade 3 | Non-HDL cholesterol, Grade 4 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Creatinine kinase, Grade 3 | Creatinine kinase, Grade 4 | Phosphorus inorganic, Grade 3 | Phosphorus inorganic, Grade 4 | Lipase, Grade 3 | Lipase, Grade 4 | Hyperkalaemia, Grade 3 | Hyperkalaemia, Grade 4 | Glomerular filtration rate, MDRD, Grade 3 | Glomerular filtration rate, MDRD, Grade 4 | Total neutrophils, Grade 3 | Total neutrophils, Grade 4 | Thrombocytopenia, Grade 3 | Thrombocytopenia, Grade 4 |
---|
ABC/3TC FDC | 6 | 0 | 8 | 0 | 19 | 0 | 2 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 3 | 2 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 0 |
,TDF/FTC FDC | 1 | 0 | 3 | 0 | 5 | 0 | 0 | 0 | 3 | 1 | 0 | 2 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 0 | 0 |
[back to top]
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72m^2, >=10%, and >=20% at Week 48
mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| >=10 mL/min, MDRD | >=10 mL/min, Cockcroft-Gault | >=20 mL/min, MDRD | >=20 mL/min, Cockcroft-Gault | >=10%, MDRD | >=10%, Cockcroft-Gault | >=20%, MDRD | >=20%, Cockcroft-Gault |
---|
ABC/3TC FDC | 23 | 15 | 4 | 4 | 21 | 11 | 4 | 3 |
,TDF/FTC FDC | 21 | 14 | 3 | 2 | 21 | 9 | 2 | 0 |
[back to top]
Number of Participants With Decline From Baseline in Estimated GFR, Calculated by MDRD and Cockcroft-Gault Equations, of >=10 mL/Min/1.73 m^2 (mL/Min for Cockcroft-Gault), >=20 mL/Min/1.72 m^2, >=10%, and >=20% at Week 24
mL, milliliter; min, minute; m^2, meters squared (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| >=10 mL/min, MDRD | >=10 mL/min, Cockcroft-Gault | >=20 mL/min, MDRD | >=20 mL/min, Cockcroft-Gault | >=10%, MDRD | >=10%, Cockcroft-Gault | >=20%, MDRD | >=20%, Cockcroft-Gault |
---|
ABC/3TC FDC | 16 | 16 | 4 | 3 | 15 | 10 | 2 | 2 |
,TDF/FTC FDC | 26 | 20 | 6 | 4 | 24 | 17 | 3 | 3 |
[back to top]
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 96
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| >=2%, spine, n=59, 79 | >=6%, spine, n=59, 79 | >=2%, hip, n=58, 76 | >=6%, hip, n=58, 76 |
---|
ABC/3TC FDC | 21 | 3 | 33 | 1 |
,TDF/FTC FDC | 39 | 8 | 52 | 13 |
[back to top]
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 48
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| >=2%, spine, n=125, 141 | >=6%, spine, n=125, 141 | >=2%, hip, n=119, 140 | >=6%, hip, n=119, 140 |
---|
ABC/3TC FDC | 51 | 5 | 54 | 3 |
,TDF/FTC FDC | 84 | 13 | 111 | 17 |
[back to top]
Number of Participants With a Decline From Baseline in Lumbar Spine and Hip Bone Mineral Density (BMD) >=2.0% and >=6.0% at Week 24
BMD is a measure of the mineral content of bone in a particular skeletal area. DXA scans use low energy x-rays to measure the density of bones. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| >=2%, spine, n=142, 165 | >=6%, spine, n=142, 165 | >=2%, hip, n=137, 160 | >=6%, hip, n=137, 160 |
---|
ABC/3TC FDC | 73 | 10 | 38 | 1 |
,TDF/FTC FDC | 115 | 17 | 93 | 6 |
[back to top]
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 96
"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Osteopenia, spine, n=64, 82 | Osteporosis, spine, n=64, 82 | Osteopenia, hip, n=65, 80 | Osteoporosis, hip, n=65, 80 |
---|
ABC/3TC FDC | 21 | 5 | 20 | 0 |
,TDF/FTC FDC | 34 | 3 | 31 | 0 |
[back to top]
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 48
"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| Osteopenia, spine, n=132, 147 | Osteporosis, spine, n=132, 147 | Osteopenia, hip, n=130, 147 | Osteoporosis, hip, n=130, 147 |
---|
ABC/3TC FDC | 41 | 15 | 37 | 4 |
,TDF/FTC FDC | 57 | 5 | 50 | 0 |
[back to top]
Number of Participants Meeting World Health Organization (WHO) Criteria for Osteopenia (T-score of -2.5 to -1.0) and Osteoporosis (T-score of <-2.5) at Week 24
"The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a normal, healthy, 30-year-old female. The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD." (NCT00549198)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Osteopenia, spine, n=147, 173 | Osteporosis, spine, n=147, 173 | Osteopenia, hip, n=149, 170 | Osteoporosis, hip, n=149, 170 |
---|
ABC/3TC FDC | 41 | 16 | 38 | 4 |
,TDF/FTC FDC | 68 | 9 | 54 | 1 |
[back to top]
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 48
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 48
Intervention | participants (Number) |
---|
| Any event | Drug hypersensitivity | Bone density decreased | Rash | Dizziness | Hypersensitivity | Drug eruption |
---|
ABC/3TC FDC | 29 | 11 | 0 | 2 | 1 | 3 | 1 |
,TDF/FTC FDC | 21 | 1 | 2 | 3 | 3 | 0 | 1 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Optimal to optimal | Optimal to near or above optimal | Optimal to borderline high | Optimal to high | Optimal to very high | Near or above optimal to optimal | Near or above optimal to near or above optimal | Near or above optimal to borderline high | Near or above optimal to high | Near or above optimal to very high | Borderline high to optimal | Borderline high to near or above optimal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to optimal | High to near or above optimal | High to borderline high | High to high | High to very high | Very high to optimal | Very high to near or above optimal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 18 | 35 | 29 | 9 | 3 | 0 | 4 | 17 | 12 | 6 | 0 | 1 | 2 | 3 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
,TDF/FTC FDC | 37 | 46 | 17 | 1 | 0 | 1 | 19 | 16 | 7 | 2 | 0 | 3 | 5 | 3 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Optimal to optimal | Optimal to near or above optimal | Optimal to borderline high | Optimal to high | Optimal to very high | Near or above optimal to optimal | Near or above optimal to near or above optimal | Near or above optimal to borderline high | Near or above optimal to high | Near or above optimal to very high | Borderline high to optimal | Borderline high to near or above optimal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to optimal | High to near or above optimal | High to borderline high | High to high | High to very high | Very high to optimal | Very high to near or above optimal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 20 | 38 | 27 | 8 | 1 | 0 | 4 | 19 | 12 | 4 | 0 | 1 | 2 | 3 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
,TDF/FTC FDC | 42 | 46 | 12 | 1 | 0 | 3 | 21 | 13 | 6 | 1 | 0 | 3 | 5 | 4 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Low-density Lipoprotein (LDL) at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <100 mg/dL, optimal; 100-<130 mg/dL, near/above optimal; 130-<160 mg/dL, borderline high; 160-<190 mg/dL, high; >=190 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Optimal to optimal | Optimal to near or above optimal | Optimal to borderline high | Optimal to high | Optimal to very high | Near or above optimal to optimal | Near or above optimal to near or above optimal | Near or above optimal to borderline high | Near or above optimal to high | Near or above optimal to very high | Borderline high to optimal | Borderline high to near or above optimal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to optimal | High to near or above optimal | High to borderline high | High to high | High to very high | Very high to optimal | Very high to near or above optimal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 22 | 41 | 22 | 6 | 1 | 0 | 6 | 17 | 12 | 4 | 0 | 1 | 2 | 4 | 3 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
,TDF/FTC FDC | 46 | 43 | 11 | 1 | 0 | 5 | 22 | 11 | 5 | 1 | 0 | 6 | 3 | 3 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150->200 mg/dL, borderline high; 200-<500 mg/dL, high;>= 500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Normal to normal | Normal to borderline high | Normal to high | Normal to very high | Borderline high to normal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to normal | High to borderline high | High to high | High to very high | Very high to normal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 47 | 25 | 34 | 1 | 4 | 4 | 11 | 1 | 2 | 4 | 11 | 5 | 0 | 0 | 0 | 1 |
,TDF/FTC FDC | 55 | 31 | 20 | 1 | 5 | 8 | 19 | 0 | 5 | 2 | 16 | 0 | 0 | 0 | 1 | 0 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Normal to normal | Normal to borderline high | Normal to high | Normal to very high | Borderline high to normal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to normal | High to borderline high | High to high | High to very high | Very high to normal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 55 | 22 | 30 | 0 | 4 | 5 | 11 | 0 | 2 | 4 | 12 | 4 | 0 | 0 | 0 | 1 |
,TDF/FTC FDC | 70 | 23 | 12 | 1 | 6 | 7 | 19 | 0 | 5 | 3 | 15 | 0 | 0 | 0 | 1 | 0 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Triglycerides at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <150 mg/dL, normal; 150-<200 mg/dL, borderline high; 200-<500 mg/dL, high; >=500 mg/dL, very high. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Normal to normal | Normal to borderline high | Normal to high | Normal to very high | Borderline high to normal | Borderline high to borderline high | Borderline high to high | Borderline high to very high | High to normal | High to borderline high | High to high | High to very high | Very high to normal | Very high to borderline high | Very high to high | Very high to very high |
---|
ABC/3TC FDC | 63 | 21 | 23 | 0 | 5 | 5 | 9 | 0 | 2 | 5 | 12 | 3 | 0 | 0 | 0 | 1 |
,TDF/FTC FDC | 78 | 19 | 9 | 0 | 7 | 10 | 15 | 0 | 6 | 3 | 15 | 0 | 0 | 0 | 1 | 0 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Desirable to desirable | Desirable to borderline high | Desirable to high | Borderline high to desirable | Borderline high to borderline high | Borderline high to high | High to desirable | High to borderline high | High to high |
---|
ABC/3TC FDC | 39 | 49 | 46 | 1 | 2 | 10 | 0 | 0 | 3 |
,TDF/FTC FDC | 86 | 47 | 10 | 1 | 9 | 8 | 0 | 0 | 2 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 48
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 48
Intervention | participants (Number) |
---|
| Desirable to desirable | Desirable to borderline high | Desirable to high | Borderline high to desirable | Borderline high to borderline high | Borderline high to high | High to desirable | High to borderline high | High to high |
---|
ABC/3TC FDC | 46 | 52 | 36 | 1 | 2 | 10 | 0 | 0 | 3 |
,TDF/FTC FDC | 96 | 37 | 9 | 1 | 9 | 8 | 0 | 0 | 2 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting Total Cholesterol at Week 24
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <200 mg/dL, desirable; 200-<240 mg/dL, borderline high; >=240 mg/dL, high. mg, milligram; dL, deciliter. (NCT00549198)
Timeframe: Baseline, Week 24
Intervention | participants (Number) |
---|
| Desirable to desirable | Desirable to borderline high | Desirable to high | Borderline high to desirable | Borderline high to borderline high | Borderline high to high | High to desirable | High to borderline high | High to high |
---|
ABC/3TC FDC | 54 | 47 | 32 | 1 | 2 | 10 | 0 | 0 | 3 |
,TDF/FTC FDC | 104 | 29 | 9 | 3 | 9 | 6 | 0 | 0 | 2 |
[back to top]
Number of Participants With the Indicated Change From Baseline in National Cholesterol Education Program (NCEP) Thresholds for Fasting High-density Lipoprotein (HDL) at Week 96
Blood samples were collected from participants for analysis of their lipid profile. Data are categorized by the maximum post-baseline threshold reached. <40 mg/dL, low; 40-<60 mg/dL, normal; >=60 mg/dL, high. (NCT00549198)
Timeframe: Baseline, Week 96
Intervention | participants (Number) |
---|
| Low to low | Low to normal | Low to high | Normal to low | Normal to normal | Normal to high | High to low | High to normal | High to high |
---|
ABC/3TC FDC | 11 | 66 | 25 | 0 | 8 | 30 | 0 | 0 | 10 |
,TDF/FTC FDC | 23 | 75 | 13 | 0 | 17 | 27 | 0 | 1 | 7 |
[back to top]
Number of Participants Experiencing an Adverse Event (AE) Leading to Discontinuation by Week 96
An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events occurring in two or more participants are presented. (NCT00549198)
Timeframe: Baseline to Week 96
Intervention | participants (Number) |
---|
| Any event | Drug hypersensitivity | Bone density decreased | Rash | Dizziness | Hypersensitivity | Abnormal dreams | Drug eruption | Depression |
---|
ABC/3TC FDC | 33 | 11 | 0 | 2 | 1 | 3 | 3 | 1 | 0 |
,TDF/FTC FDC | 28 | 1 | 8 | 3 | 3 | 0 | 0 | 1 | 2 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 44 | 23 | 10 |
,Nevirapine (NVP) Plus Truvada | 40 | 21 | 14 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 54 | 2 | 21 |
,Nevirapine (NVP) Plus Truvada | 43 | 1 | 31 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 31 | 41 | 5 |
,Nevirapine (NVP) Plus Truvada | 38 | 27 | 10 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 36
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 59 | 1 | 17 |
,Nevirapine (NVP) Plus Truvada | 54 | 3 | 18 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 24
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 63 | 3 | 11 |
,Nevirapine (NVP) Plus Truvada | 51 | 6 | 18 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 2
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 17 | 51 | 9 |
,Nevirapine (NVP) Plus Truvada | 24 | 44 | 7 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 12
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 63 | 7 | 7 |
,Nevirapine (NVP) Plus Truvada | 56 | 6 | 13 |
[back to top]
Incidence of Patients With AIDS Progression at Each Visit
Cumulative incidence of patients with AIDS progression are shown (NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
| week 0 | week 2 | week 4 | week 6 | week 8 | week 12 | week 24 | week 36 | week 48 | week 50 | End of Study Visit |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 0 | 0 | 0 | 1 | 1 | 2 | 3 | 3 | 3 | 3 | 3 |
,Nevirapine (NVP) Plus Truvada | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 |
[back to top]
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml
(NCT00552240)
Timeframe: baseline to week 48
Intervention | days (Median) |
---|
Nevirapine (NVP) Plus Truvada | 55 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 84 |
[back to top]
Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants
Time to response whereby patients withdrawing early were censored after their withdrawal (NCT00552240)
Timeframe: baseline to week 48
Intervention | days (Median) |
---|
Nevirapine (NVP) Plus Truvada | 57 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 84 |
[back to top]
Proportion of Patients Reporting Rash of Any Severity
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 21 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 19 |
[back to top]
Proportion of Patients Reporting Hepatic Events of Any Severity
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 5 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 24 |
[back to top]
Proportion of Patients Reporting CNS Side Effects of Any Severity
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 25 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 23 |
[back to top]
Percentage Adherence by Pill Count
Number of pills not returned / number of treatment days in percent (%) (NCT00552240)
Timeframe: baseline to week 48
Intervention | percentage adherence (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 94.3 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 97.0 |
[back to top]
Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48
using 4-variable Modification of Diet in Renal Disease (MDRD) formula (NCT00552240)
Timeframe: baseline to week 48
Intervention | ml/min/1.73m^2 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -0.06 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | -12.81 |
[back to top]
Change in Framingham Score
Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%. (NCT00552240)
Timeframe: baseline to week 48
Intervention | percent 10-year risk (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -0.09 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 0.14 |
[back to top]
Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio
(NCT00552240)
Timeframe: baseline to week 48
Intervention | ratio (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -0.38 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | -0.02 |
[back to top]
Change in Fasting Plasma Triglycerides Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | -4.7 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 8.4 |
[back to top]
Change in Fasting Plasma Total Cholesterol Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 18.2 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 13.8 |
[back to top]
Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 8.7 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 6.9 |
[back to top]
Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level
(NCT00552240)
Timeframe: baseline to week 48
Intervention | mg/dl (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 9.6 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 3.5 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 8.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 8
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 111.9 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 90.5 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 6.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 6
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 87.2 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 78.4 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 48.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 48
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 155.1 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 160.4 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 4.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 4
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 76.4 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 63.0 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 36.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 36
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 147.6 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 120.5 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 24.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 24
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 131.8 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 132.5 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 2.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 2
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 62.6 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 61.0 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 12.
Patients on-treatment, data within time windows (NCT00552240)
Timeframe: baseline to week 12
Intervention | cells/mm^3 (Mean) |
---|
Nevirapine (NVP) Plus Truvada | 123.1 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 102.2 |
[back to top]
AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death
"AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.~Number of cases (no time-to analysis was performed due to small numbers)." (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
Nevirapine (NVP) Plus Truvada | 1 |
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 3 |
[back to top]
Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response
HIV viral load > 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 24 and week 48
Intervention | Participants (Number) |
---|
| At week 24 | At week 48 |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 4 | 9 |
,Nevirapine (NVP) Plus Truvada | 1 | 2 |
[back to top]
Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities
(NCT00552240)
Timeframe: baseline to week 52
Intervention | participants (Number) |
---|
| Grade 2 moderate | Grade 3 severe | Grade 4 potential lifethreatening |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 31 | 7 | 3 |
,Nevirapine (NVP) Plus Truvada | 25 | 8 | 7 |
[back to top]
Number of Patients With Virologic Rebound to >400 Copies/ml
HIV viral load >400 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values < 50 copies/ml) (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Rebound following response | No rebound following response |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 6 | 63 |
,Nevirapine (NVP) Plus Truvada | 2 | 55 |
[back to top]
Number of Participants With Virologic Success (FDA Definition)
HIV viral load <50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS). (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 48 | 29 |
,Nevirapine (NVP) Plus Truvada | 42 | 33 |
[back to top]
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm
HIV viral load <50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48. (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 51 | 26 |
,Nevirapine (NVP) Plus Truvada | 48 | 27 |
[back to top]
Number of Participants With Virologic Response (VR)
VR is defined as HIV viral load of <50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. (NCT00552240)
Timeframe: baseline to week 48
Intervention | participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 50 | 27 |
,Nevirapine (NVP) Plus Truvada | 46 | 29 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 23 | 50 | 4 |
,Nevirapine (NVP) Plus Truvada | 34 | 25 | 16 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 6
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 14 | 53 | 10 |
,Nevirapine (NVP) Plus Truvada | 23 | 38 | 14 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 48 | 8 | 21 |
,Nevirapine (NVP) Plus Truvada | 42 | 2 | 31 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48
HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment. (NCT00552240)
Timeframe: baseline to week 48
Intervention | Participants (Number) |
---|
| Responders | Nonresponders |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 48 | 8 |
,Nevirapine (NVP) Plus Truvada | 42 | 2 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 4
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 10 | 62 | 5 |
,Nevirapine (NVP) Plus Truvada | 12 | 53 | 10 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 36
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 55 | 5 | 17 |
,Nevirapine (NVP) Plus Truvada | 53 | 4 | 18 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 24
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 61 | 5 | 11 |
,Nevirapine (NVP) Plus Truvada | 48 | 9 | 18 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 2
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 5 | 63 | 9 |
,Nevirapine (NVP) Plus Truvada | 6 | 62 | 7 |
[back to top]
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 12
Intervention | Participants (Number) |
---|
| HIV viral load < 50 copies/ml | HIV viral load ≥ 50 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 43 | 27 | 7 |
,Nevirapine (NVP) Plus Truvada | 42 | 20 | 13 |
[back to top]
Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment
Results within time windows, patients on-treatment (NCT00552240)
Timeframe: baseline to week 8
Intervention | Participants (Number) |
---|
| HIV viral load < 400 copies/ml | HIV viral load ≥ 400 copies/ml | Missing data |
---|
Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 58 | 15 | 4 |
,Nevirapine (NVP) Plus Truvada | 48 | 11 | 16 |
[back to top]
Head Circumference Among Infants Born to Female Participants Taking Study Drug
The slope of the linear model of the growth of infants (head circumference) during the entirety of follow-up. The head circumference of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months
Intervention | z-score difference per study month (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | -0.057 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | -0.005 |
Placebo | -0.079 |
[back to top]
Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC
"HIV-1 resistance as measured by the number of seroconverters who had an HIV-1 reverse transcriptase mutation (K65R, K70E, M184I, or M184V) conferring resistance to TDF or FTC. These mutation types were pre-defined. Plasma samples for resistance testing were collected at the visit seroconversion was first detected and again at a visit within 1 month of seroconversion. Mutations detected at either of those visits are reported.~Both seroconverters found to have a resistance mutation had been HIV infected at enrollment (TDF arm: n=1; FTC-TDF arm: n=1)." (NCT00557245)
Timeframe: Up to 36 months
Intervention | Participants (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | 1 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 1 |
Placebo | 0 |
[back to top]
Weight Among Infants Born to Female Participants Taking Study Drug
The slope of the linear model of the growth of infants (weight) during the entirety of follow-up. The weight of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months
Intervention | z-score difference per study month (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | -0.021 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0.009 |
Placebo | -0.056 |
[back to top]
Study Drug Adherence: Self-reported Missed Doses of Study Drug
Adherence to study drug measured as the percentage of visits when participants reported missing 1) any dose of study drug in the prior month and 2) 2 or more consecutive doses of study drug. (NCT00557245)
Timeframe: Up to 36 months
Intervention | percentage of visits (Number) |
---|
| Missed any doses | Missed 2+ consecutive doses |
---|
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 15 | 4 |
,Placebo | 15 | 4 |
,Tenofovir Disoproxil Fumarate (TDF) | 15 | 4 |
[back to top]
Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants
The efficacy of once daily PrEP in preventing HIV-1 acquisition among uninfected heterosexuals in HIV-1 discordant partnerships, measured by calculating the HIV incidence per 100 person-years in each of three arms. (NCT00557245)
Timeframe: Up to 36 months
Intervention | events per 100 person years (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | 0.65 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0.50 |
Placebo | 1.99 |
[back to top]
Length Among Infants Born to Female Participants Taking Study Drug
The slope of the linear model of the growth of infants (length) during the entirety of follow-up. The length of the infant was measured as a z-score, in terms of standard deviations from the age and gender specific median using the World Health Organization growth curve, accounting for skewness. The slope, representing the change over time of the z-score, was calculated using all available z-scores over 12 months and regressing against study month. (NCT00557245)
Timeframe: up to 12 months
Intervention | z-score difference per study month (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | -0.006 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 0.036 |
Placebo | -0.033 |
[back to top]
Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.
Adherence to study medication as assessed by pill count at follow-up visits. We assessed the total number of doses taken of the total dispensed doses. (NCT00557245)
Timeframe: Up to 36 months
Intervention | percentage of doses taken of dispensed (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | 97 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 97 |
Placebo | 97 |
[back to top]
Prevalence of Unprotected Sex During Follow-up
Sexual risk behavior of participants, measured as the percentage of visits when participants reported having unprotected sex during follow-up. (NCT00557245)
Timeframe: Up to 36 months
Intervention | percentage of visits (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | 14 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 13 |
Placebo | 13 |
[back to top]
Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up
"Prevalence of STIs measured as the number of participants with a positive test result for N. gonorrhoeae, C. trachomatis, or T. vaginalis during follow-up. Participants were tested for STIs at annual follow-up visits and at intervening visits at which the participant presented with symptoms of an STI. Assessment for symptomatic sexually transmitted infections was conducted quarterly.~N. gonorrhoeae and C. trachomatis testing were by APTIMA Combo 2 (Gen-Probe) or COBAS Amplicor (Roche Diagnostics). T. vaginalis testing was by APTIMA TV TMA (Gen-Probe) or In Pouch TV (Biomed Diagnostics)." (NCT00557245)
Timeframe: Up to 36 months
Intervention | participants (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | 102 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 76 |
Placebo | 85 |
[back to top]
Number of Participants With Serious Adverse Events (SAEs)
Safety of daily TDF or FTC/TDF among HIV-1 uninfected individuals randomized to TDF or FTC/TDF compared to those randomized to placebo measured as the number of participants with Serious Adverse Events (SAEs) during follow-up. (NCT00557245)
Timeframe: Up to 36 months
Intervention | Participants (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | 118 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 115 |
Placebo | 118 |
[back to top]
Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.
Infant outcomes measured as the number of live-born infants born to female participants taking study drug that had any congenital anomalies. (NCT00557245)
Timeframe: Up to 36 months
Intervention | Number of live-born infants (Number) |
---|
Tenofovir Disoproxil Fumarate (TDF) | 4 |
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) | 4 |
Placebo | 5 |
[back to top]
Number of HIV-1 Infected Participants
Of participants that were evaluable at 3 months post initiation of treatment, how many became HIV-1 infected (NCT00594646)
Timeframe: 90 days
Intervention | participants (Number) |
---|
Group 1 | 0 |
[back to top]
Medication Regimen Completion Rates
Pill counts performed at 14 and 28 days (NCT00594646)
Timeframe: 28 days
Intervention | participants (Number) |
---|
| Completed as prescribed | Stopped or Modified regimen | Lost to follow-up |
---|
Group 1 | 57 | 28 | 15 |
[back to top]
Confirmed Virologic Failure at or Prior to Week 48
Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported. (NCT00608569)
Timeframe: At or prior to Week 48
Intervention | participants (Number) |
---|
| No Failure | Experienced Failure |
---|
mDOT Arm | 95 | 34 |
,Non-mDOT Arm | 105 | 23 |
[back to top]
Confirmed Virologic Failure at or Prior to Week 24
Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) <1 log10 copies/mL below the baseline level and >400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) >400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported. (NCT00608569)
Timeframe: At or prior to Week 24
Intervention | participants (Number) |
---|
| No Failure | Experienced Failure |
---|
mDOT Arm | 105 | 24 |
,Non-mDOT Arm | 111 | 17 |
[back to top]
CD8 Count at Follow-up Visits
CD8 cell count (median, inter-quartile range) (NCT00608569)
Timeframe: At week 4, 12, 24, 36, and 48
Intervention | cells/mm3 (Median) |
---|
| Week 4 | Week 12 | Week 24 | Week 36 | Week 48 |
---|
mDOT Arm | 776 | 895 | 816 | 787 | 815 |
,Non-mDOT Arm | 859 | 916 | 818 | 833 | 823 |
[back to top]
Time to First Grade 3 or 4 Sign or Symptom
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom (NCT00608569)
Timeframe: 52 weeks since randomization
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile |
---|
mDOT Arm | 13.7 | NA |
,Non-mDOT Arm | 26.7 | 48.9 |
[back to top]
Time to First Grade 3 or 4 Lab or Sign/Symptom Event
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event (NCT00608569)
Timeframe: 52 weeks since randomization
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile |
---|
mDOT Arm | 6.4 | 24 |
,Non-mDOT Arm | 24 | 32.6 |
[back to top]
CD4 Count at Follow-up Visits
CD4 cell count (median, inter-quartile range) (NCT00608569)
Timeframe: At Weeks 4, 12, 24, 36, and 48
Intervention | cells/mm3 (Median) |
---|
| Week 4 | Week 12 | Week 24 | Week 36 | Week 48 |
---|
mDOT Arm | 212 | 225 | 268 | 281 | 301 |
,Non-mDOT Arm | 219 | 235 | 266 | 294 | 347 |
[back to top]
Adherence to Second Line HAART Regimen
Number of participants with self-reported 100% adherence over the week prior to study visit (NCT00608569)
Timeframe: At weeks 4, 8, 12, 24, 36, 48 and 52
Intervention | participants (Number) |
---|
| Week 4 | Week 8 | Week 12 | Week 24 | Week 48 | Week 52 |
---|
mDOT Arm | 105 | 108 | 114 | 107 | 103 | 104 |
,Non-mDOT Arm | 117 | 115 | 116 | 116 | 109 | 109 |
[back to top]
Time to First Grade 3 or 4 Lab Event
5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event (NCT00608569)
Timeframe: 52 weeks since randomization
Intervention | weeks (Number) |
---|
| 5th percentile | 10th percentile |
---|
mDOT Arm | 24 | NA |
,Non-mDOT Arm | NA | NA |
[back to top]
Confirmed Grade 3 or Higher ALT Elevation
Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product
Intervention | participants (Number) |
---|
Truvada Arm | 6 |
Placebo Arm | 8 |
[back to top]
FTC and/or Tenofovir Resistance
"Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected).~participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time." (NCT00625404)
Timeframe: up to 52 weeks
Intervention | participants (Number) |
---|
Truvada Arm | 3 |
Placebo Arm | 1 |
[back to top]
HIV Infection
HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens. (NCT00625404)
Timeframe: Cumulative HIV infection between enrollment and 52 weeks
Intervention | participants (Number) |
---|
Truvada Arm | 33 |
Placebo Arm | 35 |
[back to top]
Participant Report of Change in Number of Sexual Partners
Difference in mean number of reported sexual partners between final study visit and enrollment visit (NCT00625404)
Timeframe: Up to 52 weeks
Intervention | mean number of sexual partners (Mean) |
---|
Truvada Arm | -0.14 |
Placebo Arm | -0.13 |
[back to top]
Pill Counts and Participant Report of Adherence to Once-daily Pill Taking
Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts (NCT00625404)
Timeframe: Up to 52 weeks
Intervention | percentage of days (Mean) |
---|
Truvada Arm | 87 |
Placebo Arm | 89 |
[back to top]
Plasma HIV RNA Level (HIV-1 Viral Load)
Viral load at the time of HIV detection, HIV conversion and through 16 weeks (NCT00625404)
Timeframe: up to 16 weeks
Intervention | log copies/mL (Log Mean) |
---|
Truvada Arm | 4.40 |
Placebo Arm | 4.37 |
[back to top]
Pregnancy Complications
Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications (NCT00625404)
Timeframe: up to 60 weeks
Intervention | participants (Number) |
---|
Truvada Arm | 20 |
Placebo Arm | 10 |
[back to top]
Confirmed Grade 3 or Higher Reduction in Phosphorus
Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product
Intervention | participants (Number) |
---|
Truvada Arm | 45 |
Placebo Arm | 40 |
[back to top]
Confirmed Grade 3 or Higher AST Elevation
Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal (NCT00625404)
Timeframe: Through 52 weeks on product and 4 weeks post-product
Intervention | participants (Number) |
---|
Truvada Arm | 3 |
Placebo Arm | 1 |
[back to top]
Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration
The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration. (NCT00625404)
Timeframe: 10-26 months per site
Intervention | Number of adverse events (Number) |
---|
Truvada Arm | 2257 |
Placebo Arm | 2384 |
[back to top]
CD4+ T-cell Count
CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks (NCT00625404)
Timeframe: Up to 16 weeks
Intervention | cells/mL (Mean) |
---|
Truvada Arm | 579.3 |
Placebo Arm | 601.4 |
[back to top]
Confirmed Grade 2 or Higher Serum Creatinine Toxicity
Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal (NCT00625404)
Timeframe: cumulative toxicity through 52 weeks of product use and 4 weeks post product
Intervention | participants (Number) |
---|
Truvada Arm | 4 |
Placebo Arm | 2 |
[back to top]
Absolute Change in CD4 Cell Counts
(NCT00632970)
Timeframe: 24 and 48 weeks
Intervention | cells/mm^3 (Mean) |
---|
Raltegravir | 50 |
Lopinavir/Ritonavir | 50 |
[back to top]
Mean Change From Baseline Plasma HIV RNA (Log Copies/mL)
change was calculated as the mean of 12 assessments minus the baseline value (NCT00641641)
Timeframe: 12 times within 48 weeks.
Intervention | log copies/mL plasma (Mean) |
---|
Drug Intervention | 5.4 |
[back to top]
[back to top]
Time to Confirmed Virologic Failure
time to confirmed viologic failure at 24 weeks (up to 48 weeks) (NCT00654147)
Timeframe: weeks
Intervention | weeks (Median) |
---|
Raltegravir & Lopinavir/Ritonavir | 28 |
Raltegravir & Emtricitabine/Tenofovir | 29 |
[back to top]
Time to Virologic Failure
time to virologic failure at week 24 (up to 48 weeks) (NCT00654147)
Timeframe: week 24 (up to 48 weeks)
Intervention | weeks (Median) |
---|
Raltegravir & Lopinavir/Ritonavir | 3.2296 |
Raltegravir & Emtricitabine/Tenofovir | 2.9952 |
[back to top]
Change From Baseline CD4+ and CD8+ Cell Counts
mean change in CD4+ and CD8+ T-lymphocytes counts from baseline (defined as the average of pre-entry and entry values) at weeks 16 and 24 in the two treatment arms (NCT00654147)
Timeframe: Baseline, Weeks 16 and 24
Intervention | cells/mm3 (Mean) |
---|
| week 16 CD4 cells | week 24 CD4 cells |
---|
Raltegravir & Emtricitabine/Tenofovir | 452.11 | 482.36 |
,Raltegravir & Lopinavir/Ritonavir | 516.34 | 521.31 |
[back to top]
Weeks to HIV-1 RNA <200 Copies/ml
time to viral suppression noted as week on study treatment to attain HIV-1 RNA < 200 copies/ml (NCT00654147)
Timeframe: from date of treatment start to first week documented viral suppression
Intervention | week to viral supresssion (Median) |
---|
| week to <200 Copies/ml | week to <50 Copies/ml |
---|
Raltegravir & Emtricitabine/Tenofovir | 28 | 56 |
,Raltegravir & Lopinavir/Ritonavir | 28 | 56 |
[back to top]
Study Medication Tolerability
study treatment tolerability as measured by number of subjects receiving study treatment who either discontinued or changed any component of study treatment (NCT00654147)
Timeframe: date started study treatment to first week documented change study treatment up to week 48
Intervention | participants (Number) |
---|
Raltegravir & Lopinavir/Ritonavir | 1 |
Raltegravir & Emtricitabine/Tenofovir | 0 |
[back to top]
HIV RNA < 75 Copies/ml
(NCT00662545)
Timeframe: entry, week 12, and week 24
Intervention | participants (Number) |
---|
Entecavir Intensification | 5 |
Standard of Care | 5 |
[back to top]
Hepatitis B Virus (HBV) DNA
"HBV DNA carries the genetic blueprint of the virus. How many HBV DNA particles or copies are found in the blood indicates how rapidly the virus is reproducing in the liver." (NCT00662545)
Timeframe: week 24
Intervention | log 10 IU/ml (Median) |
---|
Entecavir Intensification | 2.4 |
Standard of Care | 0.8 |
[back to top]
Incidence of Permanent Discontinuation Due to Toxicity
(NCT00662545)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Entecavir Intensification | 0 |
Standard of Care | 0 |
[back to top]
Incidence of New Hepatic Decompensation( Ascites, Variceal Hemorrhage, Encephalopathy)
(NCT00662545)
Timeframe: every 4 weeks for 24 weeks
Intervention | participants (Number) |
---|
Entecavir Intensification | 0 |
Standard of Care | 0 |
[back to top]
Incidence of ALT Flares
ALT flare: sudden increase in blood level of alanine transaminase (ALT) (NCT00662545)
Timeframe: every 4 weeks for 24 weeks
Intervention | participants (Number) |
---|
Entecavir Intensification | 0 |
Standard of Care | 0 |
[back to top]
Person-years of Follow-up of Oral TDF and Oral Placebo Arms
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. Note that the data for both of these arms were censored on the date when sites were asked to discontinue treatment in the oral TDF group. (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | person-years (Number) |
---|
Oral TDF | 823 |
Oral Placebo | 838 |
[back to top]
Number of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | participants (Number) |
---|
TFV Gel | 61 |
Placebo Gel | 70 |
[back to top]
Number of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | participants (Number) |
---|
Oral TDF-FTC | 61 |
Oral Placebo | 60 |
[back to top]
Number of HIV-1 Infections of Oral TDF and Oral Placebo Arms
Participants were followed for up to 30 months. Participants were tested monthly for HIV-1 and positive rapid test results were confirmed by means of an enzyme-linked immunosorbent assay (EIA) and subsequent Western blotting (WB). (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | participants (Number) |
---|
Oral TDF | 52 |
Oral Placebo | 35 |
[back to top]
Incidence Rate of HIV-1 Infections of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | cases per 100 person-years (Number) |
---|
TFV Gel | 6.0 |
Placebo Gel | 6.8 |
[back to top]
Incidence Rate of HIV-1 Infections of Oral TDF-FTC and Oral Placebo Arms
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | cases per 100 person-years (Number) |
---|
Oral TDF-FTC | 4.7 |
Oral Placebo | 4.6 |
[back to top]
Frequency of HIV-1 Drug Resistance in Women Who Acquire HIV-1 Infection While Using Study Product
The primary resistance mutations for the study were pre-defined as K65R and K70E (which confer resistance to TDF), and M184I and M184V (which confer resistance to FTC), for their potential to cause a decrease in susceptibility to the study drug. K65R, K70E, and M184I were not detected in HIV-1 from any HIV-1 seroconverters while on study product. The number of HIV-1 seroconverters while on study with the M184V resistance mutation are reported for this outcome measure. (NCT00705679)
Timeframe: Throughout study, up to 2.5 years
Intervention | participants (Number) |
---|
| M184V mutation | No M184V mutation |
---|
Gel Placebo | 0 | 68 |
,Oral Placebo | 0 | 60 |
,Oral TDF | 0 | 58 |
,Oral TDF-FTC | 1 | 54 |
,TFV Gel | 0 | 60 |
[back to top]
Person-years of Follow-up of Tenofovir 1% Gel and Vaginal Placebo Gel Arms
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | person-years (Number) |
---|
TFV Gel | 1024 |
Placebo Gel | 1030 |
[back to top]
Person-years of Follow-up of Oral TDF-FTC and Oral Placebo Arms
Participants were followed for up to 30 months. Person-years measures the amount of time for each participant, in years, from the date of enrollment to the date of the first HIV-positive test result if HIV-infected during follow-up or to the date of the last HIV-negative test result on follow-up if not HIV-infected during follow-up. (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | person-years (Number) |
---|
Oral TDF-FTC | 1284 |
Oral Placebo | 1308 |
[back to top]
Incidence Rate of HIV-1 Infections of Oral TDF and Oral Placebo Arms
This is the number of HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status, multiplied by 100 (per 100 person-years). (NCT00705679)
Timeframe: For up to 30 months of follow-up
Intervention | cases per 100 person-years (Number) |
---|
Oral TDF | 6.3 |
Oral Placebo | 4.2 |
[back to top]
Extended Safety of Daily Tenofovir 1% Gel, Oral TDF, and Oral FTC/TDF in Women at Risk for Sexually Transmitted HIV Infection Based on Occurrence of Grade 2, 3, and 4 Adverse Events
This measure describes the number of participants with elevated serum creatinine levels, the only safety outcome of concern where a significant difference was detected between an active arm and the corresponding placebo arm. (NCT00705679)
Timeframe: Throughout study, up to 2.5 years
Intervention | participants (Number) |
---|
Oral TDF | 4 |
Oral TDF-FTC | 13 |
Oral Placebo | 2 |
TFV Gel | 9 |
Gel Placebo | 3 |
[back to top]
Mean Change From Baseline in Lactate (Millimoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | millimoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.281 |
LPV/r + RAL | 0.444 |
[back to top]
Mean Change From Baseline in Temperature (°F)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | °F (Mean) |
---|
LPV/r + FTC/TDF | -0.152 |
LPV/r + RAL | -0.183 |
[back to top]
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | picograms/milliliter (Mean) |
---|
LPV/r + FTC/TDF | -1257.9 |
LPV/r + RAL | -1594.7 |
[back to top]
Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | picograms/milliliter (Mean) |
---|
LPV/r + FTC/TDF | -138.602 |
LPV/r + RAL | -166.403 |
[back to top]
Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication
The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction. (NCT00711009)
Timeframe: Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 84.6 |
LPV/r + RAL | 86.2 |
[back to top]
Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication
The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction. (NCT00711009)
Timeframe: Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 82.5 |
LPV/r + RAL | 85.5 |
[back to top]
Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)
The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction. (NCT00711009)
Timeframe: Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 75.5 |
LPV/r + RAL | 76.0 |
[back to top]
Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 48
Intervention | Percentage of Participants (Number) |
---|
LPV/r + FTC/TDF | 84.8 |
LPV/r + RAL | 83.2 |
[back to top]
Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir
Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Participants (Number) |
---|
LPV/r + FTC/TDF | 0 |
LPV/r + RAL | 1 |
[back to top]
Mean Change From Baseline in Sodium (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.1 |
LPV/r + RAL | 0.7 |
[back to top]
Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | mm Hg (Mean) |
---|
LPV/r + FTC/TDF | -0.7 |
LPV/r + RAL | -2.4 |
[back to top]
Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | beats per minute (Mean) |
---|
LPV/r + FTC/TDF | -4.6 |
LPV/r + RAL | -6.3 |
[back to top]
Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | mm Hg (Mean) |
---|
LPV/r + FTC/TDF | -2.4 |
LPV/r + RAL | -1.8 |
[back to top]
Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^12/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.12 |
LPV/r + RAL | 0.16 |
[back to top]
Mean Change From Baseline in Potassium (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.13 |
LPV/r + RAL | 0.03 |
[back to top]
Mean Change From Baseline in Platelet Count (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | 46.8 |
LPV/r + RAL | 34.2 |
[back to top]
Mean Change From Baseline in Neutrophils (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.509 |
LPV/r + RAL | 0.705 |
[back to top]
Mean Change From Baseline in Monocytes (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.065 |
LPV/r + RAL | 0.112 |
[back to top]
Mean Change From Baseline in Mid-Thigh Measurement (cm)
Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 2.09 |
LPV/r + RAL | 5.13 |
[back to top]
Mean Change From Baseline in Mid-Arm Measurement (cm)
Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 1.76 |
LPV/r + RAL | 4.71 |
[back to top]
Mean Change From Baseline in Lymphocytes (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.332 |
LPV/r + RAL | 0.368 |
[back to top]
Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | ratio (Mean) |
---|
LPV/r + FTC/TDF | -0.056 |
LPV/r + RAL | -0.040 |
[back to top]
Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.535 |
LPV/r + RAL | 0.715 |
[back to top]
Mean Change From Baseline in Lipase (Units/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | 4.674 |
LPV/r + RAL | -1.898 |
[back to top]
Mean Change From Baseline in Leptin (Nanograms/Milliliter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | nanograms/milliliter (Mean) |
---|
LPV/r + FTC/TDF | 3.623 |
LPV/r + RAL | 2.927 |
[back to top]
Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | -21.157 |
LPV/r + RAL | -28.926 |
[back to top]
Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | nanograms/liter (Mean) |
---|
LPV/r + FTC/TDF | -1.584 |
LPV/r + RAL | -53.286 |
[back to top]
Mean Change From Baseline in Insulin (Picomoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | picomoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -6.724 |
LPV/r + RAL | 4.441 |
[back to top]
Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.046 |
LPV/r + RAL | -0.028 |
[back to top]
Mean Change From Baseline in Hips Measurement (cm)
Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 2.45 |
LPV/r + RAL | 4.70 |
[back to top]
Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.257 |
LPV/r + RAL | 0.346 |
[back to top]
Mean Change From Baseline in Hemoglobin (Grams/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/liter (Mean) |
---|
LPV/r + FTC/TDF | 5.4 |
LPV/r + RAL | 5.1 |
[back to top]
Mean Change From Baseline in Hematocrit (Fraction)
Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | % by volume of packed RBCs in blood (Mean) |
---|
LPV/r + FTC/TDF | 0.038 |
LPV/r + RAL | 0.036 |
[back to top]
Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | millimoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.011 |
LPV/r + RAL | 0.109 |
[back to top]
Mean Change From Baseline in Eosinophils (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.012 |
LPV/r + RAL | 0.015 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | -0.33 |
LPV/r + RAL | 1.52 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | -1.49 |
LPV/r + RAL | -1.25 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 7.28 |
LPV/r + RAL | 21.53 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 3.48 |
LPV/r + RAL | 6.34 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 1.67 |
LPV/r + RAL | 2.56 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 13.75 |
LPV/r + RAL | 27.01 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 2.9 |
LPV/r + RAL | 5.4 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 1.08 |
LPV/r + RAL | 1.56 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 12.71 |
LPV/r + RAL | 25.31 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 4.32 |
LPV/r + RAL | 6.96 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)
The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 15.32 |
LPV/r + RAL | 28.82 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/cm^2 (Mean) |
---|
LPV/r + FTC/TDF | -2.48 |
LPV/r + RAL | 0.68 |
[back to top]
Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)
The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | -3.69 |
LPV/r + RAL | 0.52 |
[back to top]
Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)
The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams (Mean) |
---|
LPV/r + FTC/TDF | 1.97 |
LPV/r + RAL | 2.27 |
[back to top]
Mean Change From Baseline in Creatinine (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 5.7 |
LPV/r + RAL | 1.6 |
[back to top]
Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | 398.9 |
LPV/r + RAL | 157.2 |
[back to top]
Mean Change From Baseline in Cholesterol (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.808 |
LPV/r + RAL | 1.113 |
[back to top]
Mean Change From Baseline in Chloride (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.4 |
LPV/r + RAL | 0.2 |
[back to top]
Mean Change From Baseline in Chest Measurement (cm)
Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 1.13 |
LPV/r + RAL | 4.06 |
[back to top]
Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | milliliters/second (Mean) |
---|
LPV/r + FTC/TDF | -0.122 |
LPV/r + RAL | -0.024 |
[back to top]
Mean Change From Baseline in Calcium (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.040 |
LPV/r + RAL | -0.016 |
[back to top]
Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.00 |
LPV/r + RAL | 0.37 |
[back to top]
Mean Change From Baseline in Bicarbonate (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.5 |
LPV/r + RAL | -0.8 |
[back to top]
Mean Change From Baseline in Basophils (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.005 |
LPV/r + RAL | 0.003 |
[back to top]
Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | -0.8 |
LPV/r + RAL | -9.6 |
[back to top]
Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | 14.5 |
LPV/r + RAL | 1.7 |
[back to top]
Mean Change From Baseline in Albumin (Grams/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/liter (Mean) |
---|
LPV/r + FTC/TDF | 1.4 |
LPV/r + RAL | 1.3 |
[back to top]
Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | units/liter (Mean) |
---|
LPV/r + FTC/TDF | -6.1 |
LPV/r + RAL | -13.4 |
[back to top]
Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micrograms/milliliter (Mean) |
---|
LPV/r + FTC/TDF | 2.112 |
LPV/r + RAL | 2.064 |
[back to top]
Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | number of cells x 10^9/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.90 |
LPV/r + RAL | 1.20 |
[back to top]
Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | 1.3 |
LPV/r + RAL | 1.3 |
[back to top]
Mean Change From Baseline in Weight (kg)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | kg (Mean) |
---|
LPV/r + FTC/TDF | 1.83 |
LPV/r + RAL | 3.77 |
[back to top]
Mean Change From Baseline in Waist Measurement (cm)
Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cm (Mean) |
---|
LPV/r + FTC/TDF | 1.88 |
LPV/r + RAL | 4.93 |
[back to top]
Mean Change From Baseline in Magnesium (Millimoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | millimoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.019 |
LPV/r + RAL | -0.009 |
[back to top]
Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey
The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Scores on a scale (Mean) |
---|
LPV/r + FTC/TDF | -1.0 |
LPV/r + RAL | -1.1 |
[back to top]
Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values
Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Percentage of participants (Number) |
---|
| Alananine aminotransferase >5x upper limit normal | Aspartate aminotransferase >5x upper limit normal | Creatinine phosphokinase >4x upper limit of normal | Calcium <1.75 millimoles/liter | Cholesterol >7.77 millimoles/liter | Triglycerides >8.475 millimoles/liter | Calc. creatinine clearance <50 milliliters/minute | Lipase >2x upper limit of normal | Neutrophils < 0.75 x 10^9/liter | Magnesium < 0.5 millimoles/liter |
---|
LPV/r + FTC/TDF | 2.9 | 2.9 | 8.7 | 0 | 13.5 | 4.8 | 3.8 | 7.7 | 3.8 | 0 |
,LPV/r + RAL | 5.0 | 5.0 | 19.8 | 2.0 | 16.8 | 9.9 | 1.0 | 4.0 | 0 | 2.0 |
[back to top]
[back to top]
Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm
A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Percentage of Participants (Number) |
---|
| Week 2 | Week 4 | Week 8 | Week 16 | Week 24 | Week 32 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
---|
LPV/r + FTC/TDF | 7.6 | 17.1 | 36.2 | 67.6 | 80.0 | 85.7 | 84.8 | 84.8 | 82.9 | 78.1 | 74.3 | 68.6 |
,LPV/r + RAL | 33.7 | 63.4 | 75.2 | 81.2 | 83.2 | 85.1 | 87.1 | 83.2 | 75.2 | 71.3 | 70.3 | 66.3 |
[back to top]
Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.
Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Participants (Number) |
---|
| Lopinavir resistance | Emtricitabine resistance | Tenofovir resistance | Raltegravir resistance |
---|
LPV/r + FTC/TDF | 0 | 1 | 0 | NA |
,LPV/r + RAL | 0 | 0 | 0 | 3 |
[back to top]
Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | cells/microliter (Mean) |
---|
| Week 4 | Week 8 | Week 16 | Week 24 | Week 32 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
---|
LPV/r + FTC/TDF | 97.2 | 107.9 | 158.7 | 154.9 | 180.0 | 204.6 | 245.0 | 243.4 | 277.4 | 309.6 | 296.4 |
,LPV/r + RAL | 113.4 | 124.5 | 141.6 | 174.5 | 188.2 | 223.0 | 241.9 | 250.6 | 269.9 | 280.2 | 281.0 |
[back to top]
Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672
Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | Percentage of Participants (Number) |
---|
LPV/r + FTC/TDF | 79.1 |
LPV/r + RAL | 77.8 |
[back to top]
Mean Change From Baseline in Urine Specific Gravity
Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density. (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | ratio of urine density to water density (Mean) |
---|
LPV/r + FTC/TDF | 0.0042 |
LPV/r + RAL | 0.0052 |
[back to top]
Mean Change From Baseline in Urine pH
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | pH (Mean) |
---|
LPV/r + FTC/TDF | 0.00 |
LPV/r + RAL | 0.03 |
[back to top]
Mean Change From Baseline in Uric Acid (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | -29.0 |
LPV/r + RAL | -6.1 |
[back to top]
Mean Change From Baseline in Triglycerides (Micromoles/Liter)
Included in measures of metabolic toxicity (NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.846 |
LPV/r + RAL | 1.103 |
[back to top]
Mean Change From Baseline in Total Protein (Grams/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | grams/liter (Mean) |
---|
LPV/r + FTC/TDF | -6.3 |
LPV/r + RAL | -7.2 |
[back to top]
Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)
(NCT00711009)
Timeframe: Baseline to Week 96
Intervention | micromoles/liter (Mean) |
---|
LPV/r + FTC/TDF | 0.9 |
LPV/r + RAL | 1.9 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
| TLOVR Responder Analysis | On-Treatment Response Analysis (Missing = Failure) | Snapshot Responder Analysis (Virologic Success) |
---|
ABC/3TC + PI/r | 76.3 | 77.6 | 77.6 |
,TVD + PI/r | 77.9 | 79.9 | 79.9 |
[back to top]
Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mL/min/1.73m^2 (Mean) |
---|
TVD + PI/r | -9.0 |
ABC/3TC + PI/r | -3.7 |
[back to top]
Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mL/min (Mean) |
---|
TVD + PI/r | -8.4 |
ABC/3TC + PI/r | -4.1 |
[back to top]
Change From Baseline C-Reactive Protein at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
TVD + PI/r | -0.026 |
ABC/3TC + PI/r | 0.225 |
[back to top]
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
The percentage of participants with HIV-1 RNA < 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | percentage of participants (Number) |
---|
TVD + PI/r | 86.4 |
ABC/3TC + PI/r | 83.3 |
[back to top]
Change From Baseline Fasting Glucose at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
TVD + PI/r | 1 |
ABC/3TC + PI/r | 1 |
[back to top]
Change From Baseline Fibrinogen at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
TVD + PI/r | -4 |
ABC/3TC + PI/r | 14 |
[back to top]
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | cells/microliter (Mean) |
---|
TVD + PI/r | 8 |
ABC/3TC + PI/r | 34 |
[back to top]
Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | Ratio (Mean) |
---|
TVD + PI/r | -0.1 |
ABC/3TC + PI/r | -0.1 |
[back to top]
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 200 copies/mL or the last HIV-1 RNA value >= 200 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | percentage of participants (Number) |
---|
TVD + PI/r | 99.2 |
ABC/3TC + PI/r | 97.2 |
[back to top]
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values >= 50 copies/mL or the last HIV-1 RNA value >= 50 copies/mL followed by discontinuation from the study. (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | percentage of participants (Number) |
---|
TVD + PI/r | 93.0 |
ABC/3TC + PI/r | 91.1 |
[back to top]
Change From Baseline Fasting Lipid Parameters at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | mg/dL (Mean) |
---|
| Total Cholesterol | LDL (low-density lipoprotein) | HDL (high-density lipoprotein) | Triglycerides |
---|
ABC/3TC + PI/r | -4 | 2 | 0 | -23 |
,TVD + PI/r | -21 | -6 | -2 | -51 |
[back to top]
Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
Change = Week 48 value minus baseline value (NCT00724711)
Timeframe: Baseline to 48 weeks
Intervention | pg/mL (Mean) |
---|
| IL-10 | IL-6 | TNF-alpha |
---|
ABC/3TC + PI/r | -0.2 | -0.6 | 4.7 |
,TVD + PI/r | 0.0 | -0.2 | 0.0 |
[back to top]
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA < 200 copies/mL at Week 48 was summarized. (NCT00724711)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
| On-Treatment Response Analysis (Missing = Failure) | Snapshot Responder Analysis (Virologic Success) |
---|
ABC/3TC + PI/r | 82.1 | 82.1 |
,TVD + PI/r | 84.4 | 84.4 |
[back to top]
Number of Participants Who Had Access to, and Received the Intervention
This endpoint has been included to satisfy the requirements of ClinicalTrials.gov. However, there were no prespecified endpoints in this study. (NCT00743340)
Timeframe: Up to 586 weeks
Intervention | Participants (Count of Participants) |
---|
Emtricitabine | 50 |
[back to top]
Viral Suppression Efficacy at 48 Weeks
To determine the antiviral efficacy of LPV/r + RAL compared to EFV/TDF/FTC after 48 weeks of treatment by achieving undetectable viral load (NCT00752856)
Timeframe: 48 weeks
Intervention | percentage of participants (Number) |
---|
1 - Kaletra + Isentress Taken Twice Daily | 86 |
2 - Atripla Taken Once Daily | 87.5 |
[back to top]
To Compare the Phase 1 Viral Decay Rates Between LPV/r + RAL vs. EFV/TDF/FTC Treatment Combinations.
Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interaction term in the model will indicate the difference in viral decay rates between the two treatment groups. Baseline covariate adjustment will be included if necessary. (NCT00752856)
Timeframe: Baseline, days 2, 7, 10, 14
Intervention | log(10)/day (Median) |
---|
1 - Kaletra + Isentress Taken Twice Daily | 0.47 |
2 - Atripla Taken Once Daily | 0.55 |
[back to top]
Compare Late Activated CD4+ T-cell Recovery Rates Between Treatment Regimens From Baseline to Week 48
To compare late (baseline to Week 48) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: 48 weeks
Intervention | cells/mm^3 (Mean) |
---|
1 - Kaletra + Isentress Taken Twice Daily | -2.24 |
2 - Atripla Taken Once Daily | -5.65 |
[back to top]
Compare Early Activated CD4+ T-cell Recovery Rates From Baseline to Week 4.
To compare early (baseline to Week 4) activated CD4+ T-cell recovery rates between treatment regimens. (NCT00752856)
Timeframe: Baseline to Week 4
Intervention | cells/mm^3 (Mean) |
---|
1 - Kaletra + Isentress Taken Twice Daily | -3.81 |
2 - Atripla Taken Once Daily | -1.18 |
[back to top]
Change From Baseline in Cluster of Differentiation (CD) 4 Cell Count at Week 12 and 48, Last Observation Carried Forward (LOCF).
Participants' Cluster of Differentiation (CD) 4 Cell Count were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | cells/uL (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=34,31) | Change at Week 48 (n=34,31) |
---|
Atazanavir | 326.7 | 74.6 | 187.7 |
,Darunavir | 268.3 | 103.4 | 194.9 |
[back to top]
Change From Baseline in Insulin at Week 12 and 48.
Participants insulin was analyzed at Baseline and Week 12 and 48 and change from Baseline at Week 12 and 48 were reported. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | IU/mL (Mean) |
---|
| Baseline (n=33,30) | Change at Week 12 (n=30,29) | Change at Week 48 (n=28,24) |
---|
Atazanavir | 8.59 | 0.70 | -2.88 |
,Darunavir | 5.96 | -1.07 | 0.95 |
[back to top]
Change From Baseline in Apolipoprotein B in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | g/L (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 0.8 | -0.05 | 0.0 |
,Darunavir | 0.7 | -0.004 | 0.0 |
[back to top]
Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | grams per liters (g/L) (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 1.3 | -0.007 | 0.0 |
,Darunavir | 1.1 | 0.1 | 0.1 |
[back to top]
Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA.
Number of Participants with antiviral activity, human immunodeficiency virus Type 1 (HIV-1) RNA less than (<) 50 copies per milliliters (copies/mL) or < 400 copies/mL. (NCT00757783)
Timeframe: Week 12 and 48
Intervention | number of participants (Number) |
---|
| Week12: HIV-1 RNA Less Than (<) 50 copies/mL | Week 12: HIV-1 RNA < 400 copies/mL | Week 48: HIV-1 RNA < 50 copies/mL | Week 48: HIV-1 RNA < 400 copies/mL |
---|
Atazanavir | 19 | 29 | 22 | 24 |
,Darunavir | 13 | 28 | 25 | 28 |
[back to top]
Number of Participants With Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F)
Number of participants with antiviral activity, HIV-1 RNA, missing values as treatment failure (Missing = Failure) were observed. (NCT00757783)
Timeframe: Week 12 and 48
Intervention | number of participants (Number) |
---|
| Week 12: HIV-1 RNA Less Than (<) 50 copies/mL | Week 12: HIV-1 RNA < 400 copies/mL | Week 48: HIV-1 RNA < 50 copies/mL | Week 48: HIV-1 RNA < 400 copies/mL |
---|
Atazanavir | 19 | 28 | 22 | 24 |
,Darunavir | 13 | 28 | 25 | 28 |
[back to top]
Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12 and 48
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n= 28, 27) | Change at Week 12 (n= 27, 27) | Change at Week 48 (n= 26, 22) |
---|
Atazanavir | 165.1 | 4.6 | 11.8 |
,Darunavir | 141.8 | 20.3 | 22.3 |
[back to top]
Change From Baseline in TC/HDL Ratio in the LE Set at Week 12 and 48.
Participants TC and HDL was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was calculated as ratio using observed values. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | ratio (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 3.9 | -0.1 | -0.1 |
,Darunavir | 4.1 | -0.1 | 0.1 |
[back to top]
Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=28, 27) | Change at Week 12 (n=27, 27) | Change at Week 48 (n=26, 22) |
---|
Atazanavir | 100.2 | 9.6 | 13.9 |
,Darunavir | 84.6 | 13.6 | 14.7 |
[back to top]
Change From Baseline in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) at Week 12 and 48.
Participants homeostasis model assessment-insulin resistance (HOMA-IR) were observed and change from Baseline were reported. HOMA-IR score was calculated as: (fasting plasma glucose*fasting serum insulin)/22.5. Low HOMA IR values indicate high insulin sensitivity and high HOMA IR values indicate low insulin sensitivity (insulin resistance). (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | HOMA-IR score (Mean) |
---|
| Baseline (n=27,22) | Change at Week 12 (n=20,21) | Change at Week 48 (n=19,14) |
---|
Atazanavir | 2.943 | 0.105 | -1.236 |
,Darunavir | 1.624 | -0.483 | 0.035 |
[back to top]
Change From Baseline in HIV-1 RNA Viral Load at Week 12 and 48.
the HIV-1 RNA viral load was calculated using Log Base 10 transformed HIV-1 RNA observed values. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | Log10 HIV RNA (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=32,30) | Change at Week 48 (n=29,24) |
---|
Atazanavir | 4.562 | -2.605 | -2.902 |
,Darunavir | 5.016 | -2.955 | -3.269 |
[back to top]
Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12 and 48.
Observed Values (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) | Change at Week 48 (n=26,22) |
---|
Atazanavir | 45.0 | 2.2 | 3.7 |
,Darunavir | 37.9 | 6.6 | 6.0 |
[back to top]
Change From Baseline in Glucose at Week 12 and 48.
Participants glucose level was analyzed at Baseline and Week 12 and 48. Change from Baseline at Week 12 and 48 was reported. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=33,30) | Change at Week 12 (n=30,29) | Change at Week 48 (n=28,24) |
---|
Atazanavir | 89.7 | 5.8 | 6.4 |
,Darunavir | 88.5 | 1.5 | 2.8 |
[back to top]
Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week12
Observed values. (NCT00757783)
Timeframe: Baseline, Week 12
Intervention | milligram per deciliters (mg/dL) (Mean) |
---|
| Baseline (n=28,27) | Change at Week 12 (n=27,27) |
---|
Atazanavir | 114.2 | 8.1 |
,Darunavir | 113.7 | 22.0 |
[back to top]
Change From Baseline in Cluster of Differentiation (CD) 4 Percent at Week 12 and 48, Last Observation Carried Forward (LOCF).
Participants' Cluster of Differentiation (CD) 4 percent were observed at baseline and the change values at Week 12 and 48 was calculated using LOCF. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | percentage of CD4 cells (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=32,30) | Change at Week 48 (n=29,25) |
---|
Atazanavir | 21.4 | 4.5 | 8.5 |
,Darunavir | 18.6 | 5.9 | 9.6 |
[back to top]
Change From Baseline in CD4 Cell Count at Week 12 and 48, Observed Values.
Participants' Cluster of Differentiation (CD) 4 Cell Count were at baseline and the change values at Week 12 and 48 were observed. (NCT00757783)
Timeframe: Baseline, Week 12 and 48
Intervention | cells/micro L (Mean) |
---|
| Baseline (n=34,31) | Change at Week 12 (n=32,29) | Change at Week 48 (n=29,25) |
---|
Atazanavir | 326.7 | 68.3 | 205.3 |
,Darunavir | 268.3 | 111.1 | 217.4 |
[back to top]
Change From Baseline in Log HIV Viral Load at 48 Weeks
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | copies/mL (Mean) |
---|
Raltegravir | -3.05 |
Atazanavir | -3.29 |
[back to top]
Change From Baseline in Lipids at 48 Weeks
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | mg/dL (Mean) |
---|
| Total cholesterol | Triglycerides | HDL cholesterol | LDL cholesterol |
---|
Atazanavir | 8.13 | 16.88 | -1.38 | 5.88 |
,Raltegravir | -0.25 | -15.50 | -1.5 | 4.13 |
[back to top]
Change From Baseline in Homocysteine at 6 Months
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | umol/L (Mean) |
---|
Raltegravir | 0.53 |
Atazanavir | 0.10 |
[back to top]
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | pg/mL (Mean) |
---|
Raltegravir | -2.71 |
Atazanavir | -4.47 |
[back to top]
Change From Baseline in CD4 Count at 48 Weeks
(NCT00762892)
Timeframe: Baseline and 48 weeks
Intervention | cells/uL (Mean) |
---|
Raltegravir | 192 |
Atazanavir | 205 |
[back to top]
Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96
Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases. (NCT00768989)
Timeframe: At Weeks 48 and 96 from Baseline
Intervention | Participants (Number) |
---|
Atazanavir + Raltegravir | 37 |
Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 19 |
[back to top]
Raltegravir AUC (0-12h) in 1 Dosing Interval
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 6446.4 |
[back to top]
Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count
(NCT00768989)
Timeframe: From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24
Intervention | cells/mm^3 (Mean) |
---|
| Mean change from Baseline at Week 2 (n=59, 26) | Mean change from Baseline at Week 4 (n=62, 27) | Mean change from Baseline at Week 8 (n=60, 29) | Mean change from Baseline at Week 12 (n=62, 28) | Mean change from Baseline at Week 16 (n=58, 27) | Mean change from Baseline at Week 20 (n=58, 24) | Mean change from Baseline at Week 24 (n=55, 24) |
---|
Atazanavir + Raltegravir | 81.1 | 82.7 | 111.5 | 128.6 | 143.6 | 166.5 | 166.0 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 63.1 | 100.1 | 111.9 | 129.3 | 127.6 | 140.7 | 127.0 |
[back to top]
Baseline and Mean Change From Baseline in Total Cholesterol Levels
The mean change from baseline in participant fasting lipids was determined using fasting serum samples. (NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48
Intervention | mg/dL (Mean) |
---|
| Baseline (n=56, 26) | Mean change from Baseline at Week 24 (n=51, 20) | Mean change from Baseline at Week 48 (n=38, 20) |
---|
Atazanavir + Raltegravir | 164.6 | 14.7 | 18.0 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 169.6 | 15.1 | 17.1 |
[back to top]
Raltegravir Tmax
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Geometric Mean) |
---|
Atazanavir + Raltegravir | 2.08 |
[back to top]
Raltegravir Terminal Elimination Half Life
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Mean) |
---|
Atazanavir + Raltegravir | 2.9 |
[back to top]
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)
Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Hyperkalemia | Hypokalemia | Hypernatremia | Hyponatremia | Hyperclycemia | Hypoglycemia | Creatine kinase | Albumin |
---|
Atazanavir + Raltegravir | 2 | 1 | 0 | 3 | 8 | 6 | 21 | 3 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1 | 1 | 0 | 1 | 5 | 4 | 7 | 2 |
[back to top]
Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4
AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Total Bilirubin | AST/SGOT | ALT/ SGPT | Lipase | Proteinurea | Creatine kinase |
---|
Atazanavir + Raltegravir | 62 | 11 | 10 | 11 | 14 | 21 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 28 | 8 | 8 | 13 | 11 | 7 |
[back to top]
Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants
ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Hematocrit | Hemoglobin | Platelets | Prothrombin Time | White Blood Cells |
---|
Atazanavir + Raltegravir | 1 | 2 | 1 | 12 | 22 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 0 | 0 | 1 | 7 | 14 |
[back to top]
Raltegravir Cmin Prior to the Morning Dose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 445.42 |
[back to top]
Raltegravir Cmin 12 Hours Postdose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 76.2 |
[back to top]
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation
AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event. (NCT00768989)
Timeframe: Week 1 to Week 96, continuously
Intervention | Participants (Number) |
---|
| AEs | SAEs | Deaths | AEs leading to discontinuation | SAEs leading to discontinuation |
---|
Atazanavir + Raltegravir | 60 | 7 | 0 | 4 | 1 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 29 | 2 | 0 | 1 | 0 |
[back to top]
Mean Change From Baseline in Total Bilirubin Level
(NCT00768989)
Timeframe: From Baseline to Week 24 and Week 48
Intervention | mg/dL (Mean) |
---|
| Mean change from Baseline at Week 24 | Mean change from Baseline at Week 48 |
---|
Atazanavir + Raltegravir | 2.15 | 2.08 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1.71 | 1.52 |
[back to top]
Mean Change From Baseline in Electrocardiogram Findings
The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24. (NCT00768989)
Timeframe: From Baseline to Week 24
Intervention | msec (Mean) |
---|
| QRS Interval | QTc Friderica Interval | PR Interval |
---|
Atazanavir + Raltegravir | 8.9 | -2.7 | 17.6 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 3.6 | 6.0 | 4.9 |
[back to top]
Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4
Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1-10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80. (NCT00768989)
Timeframe: While on treatment from Baseline through Week 96
Intervention | Participants (Number) |
---|
| Blood urea nitrogen | Creatinine | Hypercarbia | Hypocarbia | Hypercalcemia | Hypocalcemia | Hyperchloremia | Hypochloremia | Hyperkalemia | Hypokalemia | Hypernatremia | Hyponatremia | Hyperclycemia | Hypoglycemia |
---|
Atazanavir + Raltegravir | 0 | 3 | 1 | 15 | 2 | 1 | 0 | 1 | 2 | 6 | 0 | 3 | 8 | 6 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1 | 2 | 1 | 7 | 1 | 1 | 0 | 1 | 0 | 5 | 0 | 1 | 5 | 4 |
[back to top]
Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 19903.4 |
[back to top]
Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval
AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 39806.7 |
[back to top]
Atazanavir Cmin Prior to the Morning Dose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng*h / mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 879.25 |
[back to top]
Atazanavir Individual Inhibitory Quotient (IQ)
Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Units on a Scale (Geometric Mean) |
---|
Atazanavir + Raltegravir | 23.47 |
[back to top]
Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 3506.5 |
[back to top]
Atazanavir Terminal Elimination Half Life
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Mean) |
---|
Atazanavir + Raltegravir | 5.0 |
[back to top]
Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | Hours (Geometric Mean) |
---|
Atazanavir + Raltegravir | 3.0 |
[back to top]
Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose
(NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng•h/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 687.1 |
[back to top]
Number of Nonresponders at Week 8
Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL. (NCT00768989)
Timeframe: At Week 8 from Baseline
Intervention | Participants (Number) |
---|
Atazanavir + Raltegravir | 0 |
Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 1 |
[back to top]
Raltegravir Cmax in 1 Dosing Interval
Serial blood samples were collected over a 12-hour period after the morning dose at Week 2. (NCT00768989)
Timeframe: At Week 2 from Baseline
Intervention | ng/mL (Geometric Mean) |
---|
Atazanavir + Raltegravir | 1577.0 |
[back to top]
Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48
(NCT00768989)
Timeframe: At Week 48 from Baseline
Intervention | Participants (Number) |
---|
Atazanavir + Raltegravir | 45 |
Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 25 |
[back to top]
Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24
NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed (NCT00768989)
Timeframe: At Week 24 from Baseline
Intervention | Participants (Number) |
---|
| NC=F (n= 63, 30) | NC=M (n=58, 27) | VR-OC (n=52, 25) |
---|
Atazanavir + Raltegravir | 52 | 52 | 46 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 26 | 26 | 24 |
[back to top]
Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24
The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC). (NCT00768989)
Timeframe: At Week 24 from Baseline
Intervention | Participants (Number) |
---|
| NC=F (n=63, 30) | NC=M (n=58, 27) | VR-OC (n=52, 25) |
---|
Atazanavir + Raltegravir | 47 | 47 | 41 |
,Atazanavir + Ritonavir + Tenofovir/Emtricitabine | 19 | 19 | 19 |
[back to top]
Change in Fasting HDL Cholesterol Level From Baseline
Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
Intervention | mg/dL (Mean) |
---|
| week 48 (nA=522, nB=542, nC=506) | week 96 (nA=490, nB=505, nC=488) | week 144 (nA=364, nB=397, nC=363) |
---|
Arm A: ATV/RTV + FTC/TDF | 6 | 7 | 8 |
,Arm B: RAL + FTC/TDF | 5 | 6 | 6 |
,Arm C: DRV/RTV + FTC/TDF | 5 | 5 | 7 |
[back to top]
CD4+ T-cell Count Changes From Baseline
Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count (NCT00811954)
Timeframe: Study entry to weeks 24, 48, 96, and 144
Intervention | cells/mm^3 (Mean) |
---|
| week 24 (nA=582, nB=574, nC=579) | week 48 (nA=564, nB=565, nC=559) | week 96 (nA=523, nB=541, nC=525) | week 144 (nA=395, nB=418, nC=394) |
---|
Arm A: ATV/RTV + FTC/TDF | 157 | 218 | 284 | 324 |
,Arm B: RAL + FTC/TDF | 153 | 218 | 288 | 325 |
,Arm C: DRV/RTV + FTC/TDF | 147 | 201 | 256 | 288 |
[back to top]
Incidence of Death or AIDS Defining Events (CDC Category C)
The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence. (NCT00811954)
Timeframe: Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable
Intervention | events per 100 person-years (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 1.55 |
Arm B: RAL + FTC/TDF | 1.64 |
Arm C: DRV/RTV + FTC/TDF | 2.14 |
[back to top]
CD4+ T-cell Count
The absolute levels of CD4+ T-cell counts (cells/mm3) (NCT00811954)
Timeframe: At Weeks 24, 48, 96, and 144
Intervention | cells/mm^3 (Mean) |
---|
| week 24 (nA=582, nB=574, nC=579) | week 48 (nA=564, nB=565, nC=559) | week 96 (nA=523, nB=541, nC=525) | week 144 (nA=395, nB=418, nC=394) |
---|
Arm A: ATV/RTV + FTC/TDF | 462 | 524 | 587 | 622 |
,Arm B: RAL + FTC/TDF | 460 | 526 | 596 | 631 |
,Arm C: DRV/RTV + FTC/TDF | 457 | 509 | 564 | 596 |
[back to top]
Change in Fasting Plasma Glucose Level From Baseline
Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
Intervention | mg/dL (Mean) |
---|
| week 48 (nA=517, nB=535, nC=506) | week 96 (nA=489, nB=499, nC=481) | week 144 (nA=353, nB=392, nC=358) |
---|
Arm A: ATV/RTV + FTC/TDF | 2.2 | 3.0 | 2.2 |
,Arm B: RAL + FTC/TDF | 1.3 | 0.9 | 0.9 |
,Arm C: DRV/RTV + FTC/TDF | 2.1 | 2.5 | 3.6 |
[back to top]
Change in Fasting Total Cholesterol Level From Baseline
Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
Intervention | mg/dL (Mean) |
---|
| week 48 (nA=521, nB=542, nC=507) | week 96 (nA=490, nB=505, nC=490) | week 144 (nA=364, nB=397, nC=363) |
---|
Arm A: ATV/RTV + FTC/TDF | 13 | 16 | 20 |
,Arm B: RAL + FTC/TDF | 1 | 3 | 6 |
,Arm C: DRV/RTV + FTC/TDF | 15 | 14 | 19 |
[back to top]
Change in Fasting Triglycerides Level From Baseline
Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
Intervention | mg/dL (Mean) |
---|
| week 48 (nA=522, nB=542, nC=507) | week 96 (nA=490, nB=505, nC=490) | week 144 (nA=364, nB=397, nC=363) |
---|
Arm A: ATV/RTV + FTC/TDF | 18 | 19 | 12 |
,Arm B: RAL + FTC/TDF | -9 | -9 | -4 |
,Arm C: DRV/RTV + FTC/TDF | 16 | 16 | 20 |
[back to top]
Change in Framingham 10-year Risk of MI or Coronary Death From Baseline
"Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.~Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk." (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
Intervention | percent risk (Mean) |
---|
| week 48 (nA=509, nB=537, nC=492) | week 96 (nA=479, nB=493, nC=470) | week 144 (nA=347, nB=383, nC=349) |
---|
Arm A: ATV/RTV + FTC/TDF | 0.4 | 0.5 | 0.6 |
,Arm B: RAL + FTC/TDF | 0.0 | 0.2 | 0.4 |
,Arm C: DRV/RTV + FTC/TDF | 0.4 | 0.4 | 0.9 |
[back to top]
Change in Waist Circumference From Baseline
Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
Intervention | cm (Mean) |
---|
| week 48 (nA=555, nB=551, nC=547) | week 96 (nA=512, nB=526, nC=517) | week 144 (nA=425, nB=419, nC=409) |
---|
Arm A: ATV/RTV + FTC/TDF | 2.3 | 3.3 | 3.6 |
,Arm B: RAL + FTC/TDF | 3.1 | 4.0 | 4.0 |
,Arm C: DRV/RTV + FTC/TDF | 2.1 | 2.8 | 3.4 |
[back to top]
Change in Waist:Height Ratio From Baseline
Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio. (NCT00811954)
Timeframe: Study entry to weeks 48, 96, and 144
Intervention | cm:cm (Mean) |
---|
| week 48 (nA=555, nB=551, nC=547) | week 96 (nA=512, nB=526, nC=517) | week 144 (nA=425, nB=419, nC=409) |
---|
Arm A: ATV/RTV + FTC/TDF | 0.01 | 0.02 | 0.02 |
,Arm B: RAL + FTC/TDF | 0.02 | 0.02 | 0.02 |
,Arm C: DRV/RTV + FTC/TDF | 0.01 | 0.02 | 0.02 |
[back to top]
Self-reported Adherence
Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144. (NCT00811954)
Timeframe: At Weeks 4, 24, 48, 96, and 144
Intervention | percentage of prescribed medication (Mean) |
---|
| week 4 (nA=584, nB=590, nC=583) | week 24 (nA=570, nB=568, nC=562) | week 48 (nA=555, nB=547, nC=536) | week 96 (nA=508, nB=525, nC=507) | week 144 (nA=361, nB=376, nC=350) |
---|
Arm A: ATV/RTV + FTC/TDF | 98 | 97 | 96 | 96 | 97 |
,Arm B: RAL + FTC/TDF | 97 | 97 | 97 | 96 | 97 |
,Arm C: DRV/RTV + FTC/TDF | 98 | 96 | 96 | 96 | 98 |
[back to top]
Presence of Mutations Associated With NRTI Resistance
The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
Intervention | participants (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 8 |
Arm B: RAL + FTC/TDF | 7 |
Arm C: DRV/RTV + FTC/TDF | 3 |
[back to top]
Presence of Mutations Associated With INI Resistance
The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
Intervention | participants (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 1 |
Arm B: RAL + FTC/TDF | 1 |
Arm C: DRV/RTV + FTC/TDF | 1 |
[back to top]
Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance
The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure. (NCT00811954)
Timeframe: At the virologic failure at any time throughout the study (up to 213 weeks)
Intervention | participants (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 0 |
Arm B: RAL + FTC/TDF | 0 |
Arm C: DRV/RTV + FTC/TDF | 0 |
[back to top]
[back to top]
Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96
"The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.~A composite TLOVR endpoint defined in the CDER of the FDA document Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.~If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit." (NCT00811954)
Timeframe: From study entry to week 96
Intervention | cumulative probability per 100 persons (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 31 |
Arm B: RAL + FTC/TDF | 16 |
Arm C: DRV/RTV + FTC/TDF | 24 |
[back to top]
Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96
The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date. (NCT00811954)
Timeframe: From study entry to week 96
Intervention | cumulative events per 100 persons (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 14 |
Arm B: RAL + FTC/TDF | 1 |
Arm C: DRV/RTV + FTC/TDF | 5 |
[back to top]
Cumulative Incidence of First Adverse Event by Week 96
"The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.~The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up." (NCT00811954)
Timeframe: From study entry to week 96
Intervention | cumulative events per 100 persons (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 81 |
Arm B: RAL + FTC/TDF | 59 |
Arm C: DRV/RTV + FTC/TDF | 65 |
[back to top]
Cumulative Probability of First Virologic Failure by Week 96
"The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.~Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry." (NCT00811954)
Timeframe: From study entry to week 96
Intervention | cumulative probability per 100 persons (Number) |
---|
Arm A: ATV/RTV + FTC/TDF | 13 |
Arm B: RAL + FTC/TDF | 10 |
Arm C: DRV/RTV + FTC/TDF | 15 |
[back to top]
Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA
(NCT00827112)
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Intervention | Percentage of participants (Number) |
---|
| Week 2 (n= 55, 60) | Week 4 (n= 57, 60) | Week 8 (n= 57, 59) | Week 12 (n= 55, 59) | Week 16 (n= 54, 58) | Week 20 (n= 56, 57) | Week 24 (n= 56, 58) | Week 32 (n= 55, 57) | Week 40 (n= 54, 55) | Week 48 (n= 53, 54) | Week 60 (n= 52, 53) | Week 72 (n= 52, 53) | Week 84 (n= 50, 52) | Week 96 (n= 49, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 6.60 | 21.30 | 42.60 | 62.30 | 73.80 | 83.61 | 88.52 | 88.52 | 88.52 | 83.61 | 85.25 | 81.97 | 83.61 | 81.97 |
,Maraviroc+ Atazanavir / Ritonavir | 0 | 8.50 | 47.50 | 61.00 | 72.90 | 71.20 | 81.36 | 79.66 | 81.36 | 74.58 | 67.80 | 74.58 | 76.27 | 67.80 |
[back to top]
Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96
(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96
Intervention | log10 copies/ml (Mean) |
---|
| Baseline (n= 59, 61) | Change at Week 16 (n= 54, 58) | Change at Week 24 (n= 56, 58) | Change at Week 48 (n= 53, 54) | Change at Week 96 (n= 49, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 114827 | -107684.6 | -110498.1 | -115582.9 | -99662.6 |
,Maraviroc+ Atazanavir / Ritonavir | 84982 | -89859.1 | -87241.2 | -82343.4 | -80117.7 |
[back to top]
Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14
Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only. (NCT00827112)
Timeframe: Baseline , Days 4, 7, 10 and 14
Intervention | copies/mL (Mean) |
---|
| Change at Day 4 | Change at Day 7 | Change at Day 10 | Change at Day 14 |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | -46479.40 | -52137.10 | -54925.90 | -55449.90 |
,Maraviroc+ Atazanavir / Ritonavir | 1800.00 | -36947.90 | -58595.80 | -47271.60 |
[back to top]
Average Observed Plasma Concentration (Cavg) of Maraviroc
Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24). (NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Intervention | ng/mL (Mean) |
---|
Maraviroc+ Atazanavir / Ritonavir | 185.10 |
[back to top]
Maximum Observed Plasma Concentration (Cmax) of Maraviroc
(NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Intervention | nanogram (ng)/mL (Median) |
---|
Maraviroc+ Atazanavir / Ritonavir | 650 |
[back to top]
HIV-1 RNA Levels at Baseline
(NCT00827112)
Timeframe: Baseline
Intervention | copies/mL (Mean) |
---|
Maraviroc+ Atazanavir / Ritonavir | 84982 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 114827 |
[back to top]
Time-Averaged Difference (TAD) in log10 Viral Load
TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL). (NCT00827112)
Timeframe: Week 16, Week 24, Week 48, Week 96
Intervention | log10 copies/mL (Mean) |
---|
| Week 16 | Week 24 | Week 48 | Week 96 |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | -2.402 | -2.626 | -2.868 | -3.001 |
,Maraviroc+ Atazanavir / Ritonavir | -2.459 | -2.663 | -2.897 | -2.998 |
[back to top]
Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA
(NCT00827112)
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96
Intervention | Percentage of participants (Number) |
---|
| Week 2 (n= 55, 60) | Week 4 (n= 57, 60) | Week 8 (n= 57, 59) | Week 12 (n= 55, 59) | Week 16 (n= 54, 58) | Week 20 (n= 56, 57) | Week 24 (n= 56, 58) | Week 32 (n= 55, 57) | Week 40 (n= 54, 55) | Week 48 (n= 53, 54) | Week 60 (n= 52, 53) | Week 72 (n= 52, 53) | Week 84 (n= 50, 52) | Week 96 (n= 49, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 34.43 | 52.46 | 77.05 | 88.52 | 91.80 | 93.44 | 93.44 | 93.44 | 90.16 | 86.89 | 86.89 | 85.25 | 85.25 | 83.61 |
,Maraviroc+ Atazanavir / Ritonavir | 27.12 | 50.85 | 79.66 | 89.83 | 88.14 | 89.83 | 91.53 | 89.83 | 91.53 | 89.83 | 86.44 | 86.44 | 81.36 | 77.97 |
[back to top]
Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay
Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population. (NCT00827112)
Timeframe: Baseline to Week 96 or Time of treatment Failure
Intervention | Participants (Number) |
---|
| Baseline | Week 96 or Time of treatment Failure |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 61 | 0 |
,Maraviroc+ Atazanavir / Ritonavir | 60 | 0 |
[back to top]
Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96
(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96
Intervention | cells/microliter (cells/mcL) (Mean) |
---|
| Baseline (n= 59, 61) | Change at Week 16 (n= 54, 58) | Change at Week 24 (n= 54, 57) | Change at Week 48 (n= 52, 53) | Change at Week 96 (n= 50, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 390.00 | 139.80 | 173.30 | 226.60 | 298.50 |
,Maraviroc+ Atazanavir / Ritonavir | 357.70 | 169.60 | 188.90 | 215.70 | 287.50 |
[back to top]
Time to Loss of Virological Response (TLOVR)
TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm. (NCT00827112)
Timeframe: Baseline through Week 96
Intervention | Days (Mean) |
---|
Maraviroc+ Atazanavir / Ritonavir | 436.2 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 463.8 |
[back to top]
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
(NCT00827112)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Maraviroc+ Atazanavir / Ritonavir | 74.60 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 83.60 |
[back to top]
Number of Participants With Phenotypic Resistance
Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. (NCT00827112)
Timeframe: Week 96 or Time of treatment failure
Intervention | Participants (Number) |
---|
Maraviroc+ Atazanavir / Ritonavir | 0 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 0 |
[back to top]
Number of Participants With Genotypic Resistance
Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96. (NCT00827112)
Timeframe: Week 96 or Time of treatment failure
Intervention | Participants (Number) |
---|
Maraviroc+ Atazanavir / Ritonavir | 0 |
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 0 |
[back to top]
Minimum Observed Plasma Concentration (Cmin) of Maraviroc
(NCT00827112)
Timeframe: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)
Intervention | ng/mL (Median) |
---|
Maraviroc+ Atazanavir / Ritonavir | 37.0 |
[back to top]
Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96
(NCT00827112)
Timeframe: Baseline, Week 16, Week 24, Week 48, Week 96
Intervention | cells/mcL (Mean) |
---|
| Baseline (n= 59, 61) | Change at Week 16 (n= 54, 58) | Change at Week 24 (n= 54, 57) | Change at Week 48 (n= 52, 53) | Change at Week 96 (n= 50, 51) |
---|
Atazanavir / Ritonavir + Emtricitabine / Tenofovir | 1125.60 | -153.80 | -178.00 | -267.60 | -231.40 |
,Maraviroc+ Atazanavir / Ritonavir | 931.10 | 63.70 | 6.20 | -76.80 | -63.00 |
[back to top]
Fold Change in High Sensitivity C-reactive Protein (hsCRP) From Study Entry to Weeks 48 and 96
hsCRP was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
Intervention | Fold change (Median) |
---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0.75 | 0.85 |
,Cohort B: RAL + FTC/TDF | 0.88 | 0.78 |
,Cohort C: DRV/RTV + FTC/TDF | 0.78 | 1.31 |
[back to top]
[back to top]
Change in Brachial Artery (BA) Flow Mediated Dilation (FMD) From Study Entry to Week 24
"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to week 24 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, week 24
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | -0.05 |
Cohort B: RAL + FTC/TDF | -0.27 |
Cohort C: DRV/RTV + FTC/TDF | 0.15 |
[back to top]
Percent Change in Bone Mineral Density (BMD) of the Hip From Study Entry to Week 96
Bone mineral density (BMD) of the hip was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | -3.7 |
Cohort B: RAL + FTC/TDF | -2.2 |
Cohort C: DRV/RTV + FTC/TDF | -3.3 |
[back to top]
Percent Change in Bone Mineral Density (BMD) of the Lumber Spine From Study Entry to Week 96
Bone mineral density (BMD) of the lumber spine was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | -4.0 |
Cohort B: RAL + FTC/TDF | -1.6 |
Cohort C: DRV/RTV + FTC/TDF | -3.1 |
[back to top]
Percent Change in Bone Mineral Density (BMD) of the Total Body From Study Entry to Week 96
Bone mineral density (BMD) of the total body was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and study week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | -1.9 |
Cohort B: RAL + FTC/TDF | -0.9 |
Cohort C: DRV/RTV + FTC/TDF | -1.0 |
[back to top]
Percent Change in Lean Mass From Study Entry to Week 96
Lean mass was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | 1.8 |
Cohort B: RAL + FTC/TDF | 1.7 |
Cohort C: DRV/RTV + FTC/TDF | 0.1 |
[back to top]
Percent Change in Subcutaneous Abdominal Fat (SAT) From Study Entry to Week 96
Subcutaneous abdominal fat (SAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | 10.3 |
Cohort B: RAL + FTC/TDF | 11.8 |
Cohort C: DRV/RTV + FTC/TDF | 11.4 |
[back to top]
Percent Change in Total Limb Fat From Study Entry to Week 96
Total limb fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | 9.8 |
Cohort B: RAL + FTC/TDF | 6.3 |
Cohort C: DRV/RTV + FTC/TDF | 7.9 |
[back to top]
Percent Change in Trunk Fat From Study Entry to Week 96
Trunk fat was evaluated by dual-energy x-ray absorptiometry (DXA) scans at study entry and week 96. The percent change was calculated as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | 10.8 |
Cohort B: RAL + FTC/TDF | 13.5 |
Cohort C: DRV/RTV + FTC/TDF | 9.7 |
[back to top]
Percent Change in Visceral Abdominal Fat (VAT) From Study Entry to Week 96
Visceral abdominal fat (VAT) was evaluated by single slice abdominal computerized tomography scans at study entry and week 96. The percent change was calculated as as ((week 96 value - study entry value) / study entry value)) x 100. (NCT00851799)
Timeframe: Study entry, week 96
Intervention | percent (Median) |
---|
Cohort A: ATV/RTV + FTC/TDF | 10.7 |
Cohort B: RAL + FTC/TDF | 16.2 |
Cohort C: DRV/RTV + FTC/TDF | 9.5 |
[back to top]
CD4+ T-cell Count at Study Entry and Weeks 24, 48, 96 and 144
The absolute levels of CD4+ T-cell counts (cells/mm^3) measured at study entry and weeks 24, 48, 96 and 144. (NCT00851799)
Timeframe: Study entry, weeks 24, 48, 96 and 144
Intervention | cell/mm^3 (Median) |
---|
| Study Entry | Week 24 | Week 48 | Week 96 | Week 144 |
---|
Cohort A: ATV/RTV + FTC/TDF | 350 | 509 | 573 | 634 | 658 |
,Cohort B: RAL + FTC/TDF | 343 | 445 | 496 | 569 | 613 |
,Cohort C: DRV/RTV + FTC/TDF | 355 | 464 | 528 | 567 | 560 |
[back to top]
Change in Absolute Flow Mediated Dilation (FMD) From Study Entry to Weeks 4, 24 and 48
The change in absolute FMD was defined as the maximum absolute FMD from the RH 60 and 90 second measurements, from study entry to weeks 4, 24, and 48 (unit of measure millimeters). All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments. (NCT00851799)
Timeframe: Study entry, weeks 4, 24 and 48
Intervention | mm (Mean) |
---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0.002 | -0.002 | 0.002 |
,Cohort B: RAL + FTC/TDF | 0.012 | -0.004 | 0.005 |
,Cohort C: DRV/RTV + FTC/TDF | -0.005 | 0.008 | -0.001 |
[back to top]
Change in Brachial Artery Flow Mediated Dilation (FMD) From Study Entry to Weeks 4 and 48
"Brachial artery flow mediated dilation was measured by brachial artery reactivity tests. All results reflect measures captured from participants who reported fasting and not smoking for at least 8 hours prior to FMD assessments.~The change from study entry to weeks 4 and 48 in brachial artery FMD (%) was defined as the maximum FMD (%) calculated from resting heart rate (RH) 60 seconds and RH 90 seconds, relative to resting brachial artery diameter." (NCT00851799)
Timeframe: Study entry, weeks 4 and 48
Intervention | percent (Mean) |
---|
| Change from study entry to week 4 | Change from study entry to week 48 |
---|
Cohort A: ATV/RTV + FTC/TDF | -0.04 | -0.04 |
,Cohort B: RAL + FTC/TDF | 0.22 | -0.08 |
,Cohort C: DRV/RTV + FTC/TDF | -0.15 | -0.11 |
[back to top]
Change in CD4+ T-cell Count From Study Entry to Weeks 24, 48, 96 and 144
Change was calculated as (CD4+ T-cell count at week 24, 48, 96, or 144) - (CD4+ T-cell count at study entry). (NCT00851799)
Timeframe: Study entry to weeks 24, 48, 96, and 144
Intervention | cell/mm^3 (Median) |
---|
| Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 | Change from study entry to week 144 |
---|
Cohort A: ATV/RTV + FTC/TDF | 161 | 209 | 280 | 305 |
,Cohort B: RAL + FTC/TDF | 133 | 191 | 247 | 279 |
,Cohort C: DRV/RTV + FTC/TDF | 118 | 194 | 248 | 227 |
[back to top]
Change in Fasting Calculated Low-density Lipoprotein Cholesterol (LDL-C) From Study Entry to Weeks 4, 24, 48 and 96
Calculated LDL-C (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in calculated LDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
Intervention | mg/dL (Median) |
---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0 | 2 | 1 | 2 |
,Cohort B: RAL + FTC/TDF | -3 | -2 | -1 | -1 |
,Cohort C: DRV/RTV + FTC/TDF | 1 | 3 | 5 | 6 |
[back to top]
Change in Fasting Glucose Level From Study Entry to Weeks 4, 24, 48 and 96
Glucose (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
Intervention | mg/dL (Median) |
---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 3 | 4 | 4 | 3 |
,Cohort B: RAL + FTC/TDF | 3 | 4 | 4 | 6 |
,Cohort C: DRV/RTV + FTC/TDF | 2 | 4 | 2 | 2 |
[back to top]
Change in Fasting High-density Lipoprotein Cholesterol (HDL-C) From Study Entry to Weeks 4, 24, 48 and 96
HDL cholesterol (unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in HDL-C was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
Intervention | mg/dL (Median) |
---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | -1 | 3 | 2 | 4 |
,Cohort B: RAL + FTC/TDF | -2 | 3 | 2 | 4 |
,Cohort C: DRV/RTV + FTC/TDF | -3 | 0 | 1 | 4 |
[back to top]
Change in Fasting Insulin Level From Study Entry to Weeks 4, 24, 48 and 96
Insulin (unit of measure uIU/dL) was measured at study entry and weeks 4, 24, 48 and 96; all results reflect measures captured from participants who reported fasting for at least 8 hours prior to assessment. Change was calculated as (fasting result during at week 4, 24, 48 or 96) - (fasting result at study entry). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
Intervention | uIU/dL (Median) |
---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 4.0 | 4.0 | 4.0 | 3.5 |
,Cohort B: RAL + FTC/TDF | 3.0 | 3.0 | 3.0 | 3.0 |
,Cohort C: DRV/RTV + FTC/TDF | 3.0 | 2.0 | 3.0 | 2.0 |
[back to top]
Change in Fasting Total Cholesterol (TC) From Study Entry to Weeks 4, 24, 48 and 96
Total cholesterol (TC, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TC was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
Intervention | mg/dL (Median) |
---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 4 | 9 | 8 | 12 |
,Cohort B: RAL + FTC/TDF | -7 | -4 | -1 | 1 |
,Cohort C: DRV/RTV + FTC/TDF | 3 | 7 | 12 | 14 |
[back to top]
Change in Fasting Triglyceride (TG) From Study Entry to Weeks 4, 24, 48 and 96
Triglyceride (TG, unit of measure mg/dL) was measured at study entry and weeks 4, 24, 48 and 96 from participants who reported fasting for at least 8 hours prior to assessment; all results were centrally laboratory tested in batch. Change in TG was calculated as (week 4, 24, 48 or 96 result) - (study entry result). (NCT00851799)
Timeframe: Study entry, weeks 4, 24, 48 and 96
Intervention | mg/dL (Median) |
---|
| Change from study entry to week 4 | Change from study entry to week 24 | Change from study entry to week 48 | Change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 14 | 6 | 9 | 10 |
,Cohort B: RAL + FTC/TDF | -12 | -16 | -13 | -7 |
,Cohort C: DRV/RTV + FTC/TDF | 15 | 2 | 8 | 0 |
[back to top]
Fold Change in D-dimer From Study Entry to Weeks 48 and 96
D-dimer was measured at study entry and weeks 48 and 96 (unit of measure ug/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
Intervention | Fold change (Median) |
---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0.57 | 0.52 |
,Cohort B: RAL + FTC/TDF | 0.73 | 0.72 |
,Cohort C: DRV/RTV + FTC/TDF | 0.65 | 0.65 |
[back to top]
Fold Change in Interleukin-6 (IL-6) From Study Entry to Weeks 48 and 96
IL-6 was measured at study entry and weeks 48 and 96 (unit of measure pg/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
Intervention | Fold change (Median) |
---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0.62 | 0.89 |
,Cohort B: RAL + FTC/TDF | 0.71 | 0.82 |
,Cohort C: DRV/RTV + FTC/TDF | 0.75 | 0.89 |
[back to top]
Fold Change in Percent Expression of CD38+HLADR+ on CD4+ (Percent) From Study Entry to Weeks 24 and 96
Percent expression of CD38+HLADR+ on CD4+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96
Intervention | Fold change (Median) |
---|
| Fold change from study entry to week 24 | Fold change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0.49 | 0.38 |
,Cohort B: RAL + FTC/TDF | 0.51 | 0.34 |
,Cohort C: DRV/RTV + FTC/TDF | 0.52 | 0.37 |
[back to top]
Fold Change in Percent Expression of CD38+HLADR+ on CD8+ (Percent) From Study Entry to Weeks 24 and 96
Percent expression of CD38+HLADR+ on CD8+ was measured at study entry and weeks 24 and 96 (unit of measure percent). Fold change from study entry to week 24 or week 96 was calculated as (week 24 value or week 96 value) / (study entry value). (NCT00851799)
Timeframe: Study entry, weeks 24 and 96
Intervention | Fold change (Median) |
---|
| Fold change from study entry to week 24 | Fold change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0.51 | 0.35 |
,Cohort B: RAL + FTC/TDF | 0.56 | 0.36 |
,Cohort C: DRV/RTV + FTC/TDF | 0.59 | 0.38 |
[back to top]
Fold Change in Soluble CD14 From Study Entry to Weeks 48 and 96
Soluble CD14 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
Intervention | Fold change (Median) |
---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 1.01 | 0.98 |
,Cohort B: RAL + FTC/TDF | 0.91 | 0.90 |
,Cohort C: DRV/RTV + FTC/TDF | 1.00 | 0.98 |
[back to top]
Fold Change in Soluble CD163 From Study Entry to Weeks 48 and 96
Soluble CD163 was measured at study entry and weeks 48 and 96 (unit of measure ng/ml). Fold change from study entry to week 48 or week 96 was calculated as (week 48 value or week 96 value) / (study entry value). Results identified above or below the limit of quantification were imputed at the quantification limit of the respective assay. (NCT00851799)
Timeframe: Study entry, weeks 48 and 96
Intervention | Fold change (Median) |
---|
| Fold change from study entry to week 48 | Fold change from study entry to week 96 |
---|
Cohort A: ATV/RTV + FTC/TDF | 0.54 | 0.51 |
,Cohort B: RAL + FTC/TDF | 0.62 | 0.56 |
,Cohort C: DRV/RTV + FTC/TDF | 0.61 | 0.58 |
[back to top]
Self-reported Methamphetamine Use in Previous 30 Days.
Mean number of days (of the past 30) of methamphetamine use. (NCT00856323)
Timeframe: 3-months after baseline
Intervention | days (Mean) |
---|
PEP/CM | 1.6 |
[back to top]
Description of Incident STI Infections.
Proportional 3-month incidence of syphilis, rectal gonorrhea, pharyngeal gonorrhea, and rectal Chlamydia. (NCT00856323)
Timeframe: Baseline and 3-months
Intervention | Proportion of Participants (Mean) |
---|
PEP/CM | .074 |
[back to top]
Post-Exposure Prophylaxis Medication Adherence
Median medication adherence rate, defined as the proportion of pills taken relative to the number of pills prescribed (i.e., # of pills taken / # of pills prescribed). (NCT00856323)
Timeframe: 28-days
Intervention | proportional medication adherence (Median) |
---|
PEP/CM | 0.96 |
[back to top]
[back to top]
Area Under the Concentration Time Curve for Tenofovir, Emtricitabine and Efavirenz
The area under the concentration time curve for tenofovir, emtricitabine and efavirenz (NCT00862823)
Timeframe: 17 days
Intervention | mg*hr/mL (Geometric Mean) |
---|
| Efavirenz AUC | Emtricitabine AUC | Tenofovir AUC |
---|
Atripla Liquid | 56.7 | 10.8 | 2.2 |
,Atripla Tablet | 58.7 | 10.9 | 1.8 |
[back to top]
Maximum Concentration for Tenofovir, Emtricitabine and Efavirenz
The maximum concentration for tenofovir, emtricitabine and efavirenz (NCT00862823)
Timeframe: 17 days
Intervention | mg/L (Geometric Mean) |
---|
| Efavirenz Cmax | Emtricitabine Cmax | Tenofovir Cmax |
---|
Atripla Liquid | 1.3 | 2.1 | 0.2 |
,Atripla Tablet | 1.5 | 1.8 | 0.3 |
[back to top]
Ritonavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 7.2 |
[back to top]
Tenofovir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: between time of dosing to 24 hours after dose administered
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 2.4 |
[back to top]
Ritonavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 6.7 |
[back to top]
Atazanavir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 22.4 |
[back to top]
Emtricitabine Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 11.2 |
[back to top]
Tenofovir Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: between time of dosing tp 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 2.2 |
[back to top]
Atazanavir Systemic Exposure During the Follicular Phase (Days 6-10 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Follicular phase starts on day 1 of the menstrual cycle when estrogen and progesterone levels are lowest. this lasts 14 days. Dose administration and PK would have been drawn on day 6, 7, 8, 9, or 10 after Day 1 (start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 23.9 |
[back to top]
Emtricitabine Systemic Exposure During the Luteal Phase (Days 20-25 After Menses)
Systemic exposure determined by area under the concentration time curve was measured by blood drawn for PK assessment at the following times: 0 (time of dose), 0.5, 1, 2, 4,6, 8, 12 and 24 hours. The Luteal phase starts on day 14 of the menstrual cycle when estrogen and progesterone levels are beginning to increase. This lasts 14 days or until Day 1 of the Follicular phase. Dose administration and PK during the Luteal phase, would have been drawn on day 20, 21, 22, 23, 24 and 25 start of Follicular phase). (NCT00869960)
Timeframe: Between time of dosing to 24 hours after dose administration
Intervention | mg*h/L (Mean) |
---|
Antiretroviral Therapy | 10.2 |
[back to top]
SF-12 Physical Capacity Score
Measure of physical function out of 100. Lower score means less physical capacity. (NCT00885664)
Timeframe: 4 weeks
Intervention | units on a scale (Median) |
---|
CD4<100 | 43 |
CD4>/=100 | 54 |
[back to top]
INF Gamma
Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 2.24 |
CD4>/=100 | 1.06 |
[back to top]
IL-8
Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 7.58 |
CD4>/=100 | 5.18 |
[back to top]
IL-7
Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 17.50 |
CD4>/=100 | 10.53 |
[back to top]
IL-6
Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 4.41 |
CD4>/=100 | 4.01 |
[back to top]
IL-4
Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 0.07 |
CD4>/=100 | 0.07 |
[back to top]
IL-10
Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 21.32 |
CD4>/=100 | 10.30 |
[back to top]
IL-1 Beta
Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 0.03 |
CD4>/=100 | 0.03 |
[back to top]
SF-12 Mental Capacity Score
Measure of mental functioning where lower is better out of a scale of 100. (NCT00885664)
Timeframe: 4 weeks
Intervention | score on a scale (Median) |
---|
CD4<100 | 46 |
CD4>/=100 | 50 |
[back to top]
TNF Alpha
Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL (NCT00885664)
Timeframe: 4 weeks
Intervention | pg/mL (Median) |
---|
CD4<100 | 13.07 |
CD4>/=100 | 9.07 |
[back to top]
Symptom Score
AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale. (NCT00885664)
Timeframe: Week 4
Intervention | units on a scale (Median) |
---|
CD4<100 | 10 |
CD4>/=100 | 8 |
[back to top]
Number of Participants With Baseline Genotypic Resistance to Antiretroviral Medications
Prevalence of any of the surveillance drug resistance mutations associated with resistance to antiretroviral medications listed by the World Health Organization (NCT00924898)
Timeframe: At enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 17 |
[back to top]
Number of Participants Without Virologic Failure at Week 24
Number of participants with a HIV RNA level <200 copies/mL at week 24 (NCT00924898)
Timeframe: HIV RNA level prior to or at week 24 following enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 81 |
[back to top]
Number of Participants Without Virologic Failure at Week 48
HIV RNA level <50 copies/mL at week 48 (NCT00924898)
Timeframe: HIV RNA level at week 48 following enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 71 |
[back to top]
Number of Participants With HIV RNA Suppression at Week 96
Number of participants wtih HIV RNA level <50 copies/mL at week 96 (NCT00924898)
Timeframe: HIV RNA level at 96 weeks following enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 65 |
[back to top]
Time to HIV RNA Suppression <50 Copies/mL
Number of days from ART initiation to HIV RNA suppression <50 copies/mL (NCT00924898)
Timeframe: Number of days from start of study treatment until HIV RNA suppression, assessed through week 96
Intervention | days (Median) |
---|
Acute HIV Infection Treatment Group | 105 |
[back to top]
Number of Participants With Baseline Genotypic Resistance to One or More Antiretroviral Drugs in the Study Treatment
Baseline genotypic resistance defined as presence of any surveillance drug resistance mutation to any drug in the study treatment listed by the World Health Organization (NCT00924898)
Timeframe: At enrollment
Intervention | Participants (Count of Participants) |
---|
Acute HIV Infection Treatment Group | 71 |
[back to top]
[back to top]
Adherence
number of patients in different categories of adherence as measured by questionnaire (NCT00928187)
Timeframe: between baseline and W48
Intervention | participants (Number) |
---|
| Always above 95% | At least once 80-95% | At least once < 80% |
---|
Arm A | 50 | 89 | 11 |
,Arm B | 54 | 72 | 14 |
,Arm C | 67 | 78 | 4 |
[back to top]
Gain in CD4 Cells Between Baseline and W48
median gain in circulating CD4 cells between baseline and W48 (NCT00928187)
Timeframe: between baseline and 48 weeks
Intervention | cell/mm3 (Median) |
---|
Arm A | 133 |
Arm B | 136 |
Arm C | 115 |
[back to top]
Number of Patients Discontinuing Study Treatment
number of patients discounting treatment because of adverse events (NCT00928187)
Timeframe: between baseline and W48
Intervention | participants (Number) |
---|
Arm A | 0 |
Arm B | 4 |
Arm C | 1 |
[back to top]
Number of Patients With HIV Plasma Viral Load < 200 Copies/ml
number of patients having a plasma viral load below 200 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Arm A | 127 |
Arm B | 117 |
Arm C | 129 |
[back to top]
Number of Patients With HIV Plasma Viral Load < 50 Copies/ml
Snapshot of patients with HIV viral load less then 50 copies/ml at week 24 (NCT00928187)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Arm A | 90 |
Arm B | 81 |
Arm C | 97 |
[back to top]
Number of Patients With Plasma HIV RNA < 50 Copies/mL
(NCT00928187)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
Arm A | 105 |
Arm B | 92 |
Arm C | 97 |
[back to top]
Number of Patients With Resistance Mutations
number of patients with resistance mutations after second line treatment failure (HIV RNA> 1000 copies/ml) (NCT00928187)
Timeframe: between W12 and W48
Intervention | participants (Number) |
---|
Arm A | 0 |
Arm B | 0 |
Arm C | 0 |
[back to top]
Patients With Plasma HIV RNA < 200 Copies/ml
number of patients with plasma HIV RNA below 200 copies/ml (NCT00928187)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
Arm A | 130 |
Arm B | 118 |
Arm C | 127 |
[back to top]
Tolerance: Equal or Superior to a 25% Reduction in eGFR (Glomerular Filtration Rate)
evaluation of estimated glomerular filtration rate and number of participant with a decrease equal or superior to 25% of the baseline value (NCT00928187)
Timeframe: between baseline and W48
Intervention | participants (Number) |
---|
Arm A | 28 |
Arm B | 14 |
Arm C | 19 |
[back to top]
Tolerance: Gastrointestinal Complains
Gastrointestinal complaints (grade 1 to 4) between baseline and W48. (NCT00928187)
Timeframe: between baseline and 48 weeks
Intervention | participants (Number) |
---|
Arm A | 50 |
Arm B | 48 |
Arm C | 26 |
[back to top]
Tolerance: Neuropathies (Grade 1 to 4)
any symptom of peripheral neuropathy (NCT00928187)
Timeframe: between baseline and W48
Intervention | participants (Number) |
---|
Arm A | 5 |
Arm B | 11 |
Arm C | 8 |
[back to top]
[back to top]
Maintenance of Virologic Suppression
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL. (NCT00931801)
Timeframe: 48 weeks
Intervention | participants (Number) |
---|
| Virologic Response | Confirmed Virologic Failures | Withdrawal Due to AE; HIV RNA < 50 copies/mL | Other Withdrawal; HIV RNA < 50 copies/mL |
---|
Control Arm | 13 | 0 | 0 | 1 |
,Intervention Arm No.1 | 14 | 0 | 0 | 1 |
,Intervention Arm No.2 | 10 | 3 | 1 | 0 |
[back to top]
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment. (NCT00931801)
Timeframe: baseline and 48 weeks
Intervention | units on a scale (Mean) |
---|
| Mean Quality of Life Score at Baseline | Mean Quality of Life Score at Week 48 | Change in Quality of Life |
---|
Control Arm | 92.9 | 90.5 | -2.5 |
,Intervention Arm No.1 | 77.4 | 78.2 | 0.8 |
,Intervention Arm No.2 | 82.5 | 81.3 | -1.3 |
,Total | 84.2 | 83.3 | -0.9 |
[back to top]
The Difference in CD4 From Baseline to Week 48
Change in mean CD4 from Baseline to Week 48. (NCT00931801)
Timeframe: Baseline and Week 48
Intervention | cells/mm3 (Mean) |
---|
| CD4 at Baseline | CD4 at Week 48 | CD4 Change |
---|
Control Arm | 535.8 | 611.2 | 75.4 |
,Intervention Arm No.1 | 514.1 | 526.3 | 12.1 |
,Intervention Arm No.2 | 539.1 | 507.2 | -31.9 |
,Total | 528.3 | 549.3 | 21.0 |
[back to top]
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits. (NCT00931801)
Timeframe: Baseline and Week 48
Intervention | percentage of prescribed doses (Mean) |
---|
| 3 Day Adherence Recall at Baseline | 3 Day Adherence Recall at Week 48 | Change in 3 Day Adherence Recall |
---|
Control Arm | 100 | 100 | 0 |
,Intervention Arm No.1 | 97.5 | 97.5 | 0 |
,Intervention Arm No.2 | 96.7 | 95.0 | -1.7 |
,Total | 98.1 | 97.6 | -0.5 |
[back to top]
Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 24 weeks
Intervention | percentage of body fat (Median) |
---|
| Total body fat | Limb fat | Trunk fat |
---|
Etravirine 400 mg Once Daily | 0.43 | 0.48 | 0.32 |
[back to top]
The Proportion of Participants With HIV RNA <50 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 96 weeks
Intervention | proportion of participants (Number) |
---|
Etravirine 400 mg Once Daily | 0.71 |
[back to top]
The Proportion of Participants With HIV RNA <200 Copies/mL at Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 24 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 24 weeks
Intervention | proportion of participants (Number) |
---|
Etravirine 400 mg Once Daily | 0.89 |
[back to top]
The Antiretroviral Activity of Etravirine 400 mg Given Once Daily, With Fixed-dose Truvada Once Daily, Among Treatment-naïve HIV-1 Infected Adults as Measured by the Percentage of Participants With HIV RNA < 50 Copies/mL at Week 24
The primary study endpoint was the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 24 of study participation. The per-protocol primary analysis was conducted intention-to-treat, with missing evaluations counted as failures. Achievement of HIV-1 viral load below 50 copies/ml was defined as having HIV-1 RNA <50 copies/ml during the Week 24 analysis window (>18 and <30 weeks post-entry). (NCT00959894)
Timeframe: 24 weeks
Intervention | proportion of participants (Number) |
---|
Etravirine 400 mg Once Daily | 0.87 |
[back to top]
Probability of Remaining Free of a Safety/Tolerability Event at 96 Weeks
The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring). (NCT00959894)
Timeframe: 96 weeks
Intervention | proportion of participants (Number) |
---|
Etravirine 400 mg Once Daily | 0.69 |
[back to top]
The Proportion of Participants With HIV RNA <200 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <200 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 48 weeks
Intervention | proportion of participants (Number) |
---|
Etravirine 400 mg Once Daily | 0.82 |
[back to top]
The Proportion of Participants With HIV RNA <200 Copies/mL at Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA 200 copies/ml at Week 96 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 96 weeks
Intervention | proportion of participants (Number) |
---|
Etravirine 400 mg Once Daily | 0.77 |
[back to top]
Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults: Etravirine AUC-24 Hours at Steady State
Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA) (NCT00959894)
Timeframe: At or after 4 weeks
Intervention | ng*hr/mL (Median) |
---|
Etravirine 400 mg Once Daily | 8024.40 |
[back to top]
The Proportion of Participants With HIV RNA <50 Copies/mL at Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
This secondary outcome assessed the proportion of participants who achieved HIV-1 RNA <50 copies/ml at Week 48 of study treatment. The per-protocol analysis was conducted intention-to-treat, with missing evaluations counted as failures. (NCT00959894)
Timeframe: 48 weeks
Intervention | proportion of participants (Number) |
---|
Etravirine 400 mg Once Daily | 0.77 |
[back to top]
Pharmacokinetics of Etravirine in Genital Secretions of up to 10 Men and up to 10 Women at Week 4 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
This secondary outcome measure assessed the ratio of semen:plasma concentration of etravirine in paired semen and plasma samples collected from 14 male participants at Week 4 of treatment with etravirine and fixed dose tenofovir/emtricitabine. (NCT00959894)
Timeframe: 4 weeks
Intervention | ratio of semen:plasma drug concentration (Median) |
---|
Etravirine 400 mg Once Daily | 0.192 |
[back to top]
[back to top]
Tolerability of Etravirine in HIV-1 Infected Adults Initiating Antiretroviral Therapy
"The safety/tolerability endpoint was defined as the first grade 3 or higher sign, symptom or laboratory abnormality that was at least one grade higher than baseline among participants ever exposed to etravirine (regardless of treatment status), or permanent discontinuation of etravirine due to any toxicity (regardless of grade). Modification of tenofovir/emtricitabine was not a safety/tolerability event.~The Kaplan-Meier method was used to estimate the proportion of participants ever exposed to etravirine who remained event-free through Week 96, with a 95% CI using Greenwood's variance estimate and a log-log transformation. Time was handled as continuous (weeks from treatment start to event or censoring)." (NCT00959894)
Timeframe: 96 weeks
Intervention | participants (Number) |
---|
| At least one safety/tolerability event | Signs or Symptoms | Laboratory Abnormalities |
---|
Etravirine 400 mg Once Daily | 23 | 13 | 10 |
[back to top]
Resistance Mutations in the Subset of Patients With Confirmed Virologic Failure Who Have HIV RNA >500 Copies/mL and Genotype Resistance Results
Per-protocol, genotype testing was conducted at confirmation of virologic failure if the confirmatory HIV-1 RNA was above the laboratory-specified threshold of 500 copies/mL. HIV-1 genotype was determined using the TRUGENE® HIV-1 assay (Siemens Healthcare Diagnostics, Tarrytown, NY) (NCT00959894)
Timeframe: 96 weeks
Intervention | participants (Number) |
---|
| Y181C | E138K | E138K, Y181C, M230L, M184I, K219E, V75I | No resistance-associated mutations detected |
---|
Etravirine 400 mg Once Daily | 1 | 1 | 1 | 3 |
[back to top]
Population Pharmacokinetics of Etravirine 400 mg Once Daily, in Combination With Fixed-dose Emtricitabine-tenofovir Among Treatment-naïve HIV-1 Infected Adults
Population pharmacokinetics were calculated using sparse sampling. Plasma concentrations of etravirine measured in samples from participants who provided blood samples at multiple study visits, with variation in sampling times relative to dosing of etravirine used to cover the spectrum of the dosing schedule. Model simulations and fitting were performed with NONMEM ® 7.3. (ICON, plc) and model exploration was performed with Berkeley Madonna (Berkeley, CA, USA) (NCT00959894)
Timeframe: At or after 4 weeks
Intervention | ng/mL (Median) |
---|
| Etravirine trough plasma concentration | Etravirine peak plasma concentration |
---|
Etravirine 400 mg Once Daily | 217.47 | 480.99 |
[back to top]
[back to top]
[back to top]
Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks
Intervention | ratio of trunk fat % : lower limb fat % (Median) |
---|
Etravirine 400 mg Once Daily | 0.06 |
[back to top]
Change in Fat Mass Ratio as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
Change from baseline to follow-up in fat mass ratio was calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Fat mass ratio was calculated as the ratio of trunk fat percentage and lower limb fat percentage (% trunk fat mass / % lower limb fat mass). Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 24 weeks
Intervention | ratio of trunk fat % : lower limb fat % (Median) |
---|
Etravirine 400 mg Once Daily | 0.02 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 24 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
The per-protocol analysis of change in CD4+ cell count from baseline to Week 24 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% confidence interval (CI). (NCT00959894)
Timeframe: Baseline to 24 weeks
Intervention | cells/uL (Median) |
---|
Etravirine 400 mg Once Daily | 156 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 96 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks
Intervention | cells/uL (Median) |
---|
Etravirine 400 mg Once Daily | 224 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 48 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
The per-protocol intention-to-treat analysis of change in CD4+ cell count from baseline to Week 48 was calculated using the measurement closest to schedule and within the analysis window, and quantified with an estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 48 weeks
Intervention | cells/uL (Median) |
---|
Etravirine 400 mg Once Daily | 163 |
[back to top]
[back to top]
[back to top]
[back to top]
Change in Limb and Trunk Fat Distribution as Measured by DEXA Scan, in the Same Subgroup of up to 40 Participants (as in Aim 8), From Baseline to Week 96 of Treatment With Etravirine and Fixed-dose Tenofovir/Emtricitabine
Changes from baseline to follow-up in limb fat, trunk fat, total body fat, and lean mass were calculated. Whole body Dual X-ray Absorptiometry (DEXA) scans (Hologic Discovery W, Hologic Inc., Bedford, MA) were conducted at baseline, Week 24, and Week 96 to assess body fat distribution. Calculations of change from baseline to follow-up used the value closest to schedule and within the analysis window, and were quantified with the estimated median and distribution-free 95% CI. (NCT00959894)
Timeframe: Baseline to 96 weeks
Intervention | percentage of body fat (Median) |
---|
| Total body fat | Limb fat | Trunk fat |
---|
Etravirine 400 mg Once Daily | 1.44 | 0.82 | 1.93 |
[back to top]
Change in Peak Oxygen Uptake.
change or difference in peak oxygen uptake after switching from zidovudine-based therapy, such as combivir or trizivir, to tenofovir, versus continuing on zidovudine-based therapy.The difference in peak oxygen uptake were calculated by subtracting peak oxygen uptake values at baseline from the peak oxygen uptake values after 6 months of study intervention. The changes were analyzed within each group and between groups. (NCT00960622)
Timeframe: baseline and 6 months
Intervention | ml/Kg/min (Mean) |
---|
Truvada 200/300 mg, Daily, by Mouth. | 2.2 |
Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily. | 2.8 |
[back to top]
[back to top]
Mean Change in Estimated Ultrasensitive Plasma HIV RNA Levels Between Baseline and Week 24
The isothermal transcription mediated amplification (TMA) assay (Aptima, Gen-Probe/Hologic) was used to measure ultrasensitive plasma HIV RNA levels at weeks 0, 4, 12, and 24. This is a nucleic acid-amplification test that has been FDA-approved for the early detection of HIV infection in blood donors. It is a highly specific and sensitive assay, with a singlicate 50% detection limit of 3.6-14 copies/mL. The assay was performed in triplicate on 0.5 mL plasma (1.5 mL total plasma), improving the overall 50% detection limit to < 5 copies/mL. (NCT01025427)
Timeframe: 24 weeks
Intervention | fold decrease in signal/cutoff ratio (Mean) |
---|
HIV Controller | 66 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 16
(NCT01033942)
Timeframe: Week 16
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 6 | 2 | 4 | 0 |
,Placebo Pill Control | 5 | 1 | 9 | 0 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 20
(NCT01033942)
Timeframe: Week 20
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 4 | 3 | 4 | 0 |
,Placebo Pill Control | 6 | 2 | 6 | 0 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 24
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 2 | 3 | 4 | 0 |
,Placebo Pill Control | 8 | 0 | 4 | 0 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 24
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 9 |
Placebo Pill Control | 7 |
No Pill Control | 10 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 4
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 4
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 15 |
Placebo Pill Control | 14 |
No Pill Control | 12 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 8
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 8
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 10 |
Placebo Pill Control | 12 |
No Pill Control | 10 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 12
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 60 |
Placebo Pill Control | 0 |
No Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 16
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 53.8 |
Placebo Pill Control | 0 |
No Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 20
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 41.7 |
Placebo Pill Control | 0 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 24
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 20 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 4
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 63.2 |
Placebo Pill Control | 0 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 4
(NCT01033942)
Timeframe: Week 4
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 9 | 4 | 5 | 1 |
,Placebo Pill Control | 10 | 1 | 6 | 1 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 8
(NCT01033942)
Timeframe: Week 8
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 8 | 5 | 4 | 0 |
,Placebo Pill Control | 9 | 2 | 7 | 0 |
[back to top]
Perceived HIV Risk Reduction at Week 12: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 57.14 | 28.57 | 7.14 | 7.14 | 0.00 |
,No Pill Control | 50.00 | 18.75 | 25.00 | 6.25 | 0.00 |
,Placebo Pill Control | 81.25 | 12.50 | 6.25 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 12: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 64.29 | 0.00 | 21.43 | 14.29 | 0.00 |
,No Pill Control | 43.75 | 18.75 | 18.75 | 18.75 | 0.00 |
,Placebo Pill Control | 68.75 | 12.50 | 12.50 | 6.25 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 12: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 73.33 | 20.00 | 6.67 | 0.00 | 0.00 |
,No Pill Control | 43.75 | 18.75 | 25.00 | 12.50 | 0.00 |
,Placebo Pill Control | 81.25 | 6.25 | 6.25 | 0.00 | 6.25 |
[back to top]
Perceived HIV Risk Reduction at Week 12: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been on this study." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 46.67 | 13.33 | 13.33 | 13.33 | 13.33 |
,No Pill Control | 25.00 | 25.00 | 18.75 | 18.75 | 12.50 |
,Placebo Pill Control | 68.75 | 6.25 | 18.75 | 6.25 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 12: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 60.00 | 33.33 | 6.67 | 0.00 | 0.00 |
,No Pill Control | 68.75 | 18.75 | 12.50 | 0.00 | 0.00 |
,Placebo Pill Control | 93.75 | 0.00 | 6.25 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 16: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 25.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 42.86 | 28.57 | 14.29 | 7.14 | 7.14 |
,Placebo Pill Control | 80.00 | 6.67 | 13.33 | 0.00 | 0.00 |
[back to top]
Actual Number of Study Visits Completed by 24 Weeks
This outcome measure looked at whether the actual number of study visits conducted by 24 weeks differed by treatment group over time. (NCT01033942)
Timeframe: 24 weeks
Intervention | Visits (Least Squares Mean) |
---|
FTC/TDF as PrEP | 3.5927 |
Placebo Pill Control | 4.6263 |
No Pill Control | 4.6374 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Overall
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: 20 Weeks
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 12
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 12
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 16
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 16
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 20
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 20
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 4
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 4
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Medication Refill Dates-Week 8
Missed doses were calculated as the number of days between the actual and expected refill dates. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 8
Intervention | Missed doses (Median) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 12
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 12
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 10 |
Placebo Pill Control | 6.5 |
[back to top]
Perceived HIV Risk Reduction at Week 16: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 53.85 | 15.38 | 23.08 | 7.69 | 0.00 |
,No Pill Control | 42.86 | 42.86 | 7.14 | 0.00 | 7.14 |
,Placebo Pill Control | 93.33 | 0.00 | 6.67 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 16: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 58.33 | 33.33 | 8.33 | 0.00 | 0.00 |
,No Pill Control | 35.71 | 21.43 | 28.57 | 0.00 | 14.29 |
,Placebo Pill Control | 80.00 | 6.67 | 13.33 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 16: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 46.15 | 15.38 | 15.38 | 7.69 | 15.38 |
,No Pill Control | 42.86 | 14.29 | 7.14 | 21.43 | 14.29 |
,Placebo Pill Control | 66.67 | 6.67 | 6.67 | 20.00 | 0.00 |
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Baseline
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Baseline
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 0 |
Placebo Pill Control | 0 |
[back to top]
Perceived HIV Risk Reduction at Week 20: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 16.67 | 0.00 | 8.33 | 0.00 |
,No Pill Control | 61.54 | 23.08 | 7.69 | 7.69 | 0.00 |
,Placebo Pill Control | 92.86 | 7.14 | 0.00 | 0.00 | 0.00 |
[back to top]
Frequency of Missing Study Pills Because Participant Ran Out of Study Pills
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 94.12 | 4.71 | 0.00 | 1.18 |
,Placebo Pill Control | 97.85 | 1.08 | 1.08 | 0.00 |
[back to top]
Frequency of Missing Study Pills Because Participant Had Too Many Study Pills to Take
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 92.94 | 7.06 | 0.00 | 0.00 |
,Placebo Pill Control | 95.70 | 2.15 | 1.08 | 1.08 |
[back to top]
Frequency of Missing Study Pills Because Participant Had a Change in Daily Routine
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 62.35 | 25.53 | 7.06 | 7.06 |
,Placebo Pill Control | 70.97 | 15.05 | 10.75 | 3.23 |
[back to top]
Frequency of Missing Study Pills Because Participant Felt Sick or Ill
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 81.18 | 11.76 | 4.71 | 2.35 |
,Placebo Pill Control | 89.25 | 5.38 | 3.23 | 2.15 |
[back to top]
Acceptability of Risk Reduction Counseling at Every Visit
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 1 | 9 | 10 |
,No Pill Control | 0 | 4 | 9 | 6 |
,Placebo Pill Control | 1 | 5 | 6 | 7 |
[back to top]
Acceptability of Questions About Sexual Behavior at Every Visit
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 0 | 1 | 9 | 10 |
,No Pill Control | 0 | 0 | 4 | 9 | 6 |
,Placebo Pill Control | 1 | 1 | 4 | 6 | 7 |
[back to top]
Acceptability of Physical Examination by a Doctor
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 1 | 2 | 7 | 10 |
,No Pill Control | 0 | 0 | 3 | 10 | 6 |
,Placebo Pill Control | 3 | 0 | 3 | 6 | 7 |
[back to top]
Acceptability of Participating in Group Sessions
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 1 | 0 | 9 | 10 |
,No Pill Control | 0 | 0 | 4 | 9 | 6 |
,Placebo Pill Control | 1 | 2 | 2 | 7 | 7 |
[back to top]
Acceptability of Health Clinic for Study Visits
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 4 | 6 | 10 |
,No Pill Control | 0 | 3 | 10 | 6 |
,Placebo Pill Control | 2 | 4 | 6 | 7 |
[back to top]
Acceptability of Having an HIV Test at Every Visit
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 0 | 0 | 10 | 10 |
,No Pill Control | 0 | 1 | 12 | 6 |
,Placebo Pill Control | 1 | 3 | 8 | 7 |
[back to top]
Acceptability of Being Randomly Assigned to a Group
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 1 | 3 | 4 | 1 | 11 |
,No Pill Control | 0 | 2 | 5 | 6 | 6 |
,Placebo Pill Control | 4 | 2 | 4 | 2 | 7 |
[back to top]
[back to top]
Percentage of Participants With Tenofovir Plasma Concentrations (mg/mL) Detected at Week 8
Subjects reporting tenofovir is calculated as those subjects that had a tenofovir plasma concentration greater than zero (BLQ). Subjects with BLQ+ (<10 ng/mL) were included in this count. (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
FTC/TDF as PrEP | 47.1 |
Placebo Pill Control | 0 |
No Pill Control | 0 |
[back to top]
Frequency of Missing Study Pills Because Participant Felt Depressed/Overwhelmed
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 83.53 | 12.94 | 0.00 | 3.53 |
,Placebo Pill Control | 92.47 | 2.15 | 3.23 | 2.15 |
[back to top]
Frequency of Missing Study Pills Because Participant Fell Asleep/Slept Through Dose Time
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 68.24 | 24.71 | 4.71 | 2.35 |
,Placebo Pill Control | 86.02 | 6.45 | 4.30 | 3.23 |
[back to top]
Frequency of Missing Study Pills Because Participant Didn't Think it Was Needed Because he/She Was Not Engaged in Risky Sex
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 90.59 | 4.71 | 1.18 | 3.53 |
,Placebo Pill Control | 96.77 | 0.00 | 2.15 | 1.08 |
[back to top]
Frequency of Missing Study Pills Because Participant Did Not Want Others to Notice Participant Was Taking Medications
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 88.24 | 5.88 | 2.35 | 3.53 |
,Placebo Pill Control | 92.47 | 4.30 | 0.00 | 3.23 |
[back to top]
Frequency of Missing Pills Because Participant Felt Like the Study Pill Was Toxic/Harmful
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 87.06 | 5.88 | 3.53 | 3.53 |
,Placebo Pill Control | 95.70 | 2.15 | 0.00 | 2.15 |
[back to top]
Acceptability of the Taste of the Pill
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 4 | 1 | 4 | 1 | 10 |
,Placebo Pill Control | 3 | 4 | 5 | 0 | 7 |
[back to top]
Acceptability of the Color of the Pill
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 1 | 2 | 4 | 3 | 10 |
,Placebo Pill Control | 1 | 3 | 5 | 3 | 7 |
[back to top]
Acceptability of Taking the Pill Everyday
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 3 | 3 | 2 | 2 | 10 |
,Placebo Pill Control | 1 | 7 | 4 | 0 | 7 |
[back to top]
Acceptability of Taking Part in the Study
(NCT01033942)
Timeframe: Week 24
Intervention | participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 2 | 0 | 0 | 8 | 10 |
,No Pill Control | 0 | 0 | 1 | 12 | 6 |
,Placebo Pill Control | 0 | 1 | 2 | 9 | 7 |
[back to top]
Acceptability of Size of Pill
(NCT01033942)
Timeframe: Week 24
Intervention | Participants (Number) |
---|
| Did not like it at all | Did not like | Liked | Liked a lot | Missing response |
---|
FTC/TDF as PrEP | 3 | 3 | 3 | 1 | 10 |
,Placebo Pill Control | 3 | 3 | 6 | 0 | 7 |
[back to top]
Frequency of Missing Study Pills Because Participant Simply Forgot
(NCT01033942)
Timeframe: 24 Weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 38.82 | 40.00 | 9.41 | 11.76 |
,Placebo Pill Control | 60.22 | 16.13 | 15.05 | 8.60 |
[back to top]
Perceived HIV Risk Reduction at Week 16: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 25.00 | 0.00 | 8.33 | 0.00 |
,No Pill Control | 71.43 | 7.14 | 7.14 | 7.14 | 7.14 |
,Placebo Pill Control | 93.33 | 6.67 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 20: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 25.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 38.46 | 15.38 | 15.38 | 23.08 | 7.69 |
,Placebo Pill Control | 78.57 | 7.14 | 7.14 | 7.14 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 20: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 25.00 | 8.33 | 0.00 | 0.00 |
,No Pill Control | 53.85 | 23.08 | 15.38 | 7.69 | 0.00 |
,Placebo Pill Control | 78.57 | 14.29 | 7.14 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 20: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 75.00 | 8.33 | 8.33 | 0.00 | 8.33 |
,No Pill Control | 61.54 | 15.38 | 7.69 | 7.69 | 7.69 |
,Placebo Pill Control | 71.43 | 21.43 | 0.00 | 7.14 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 20: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 91.67 | 8.33 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 61.54 | 30.77 | 7.69 | 0.00 | 0.00 |
,Placebo Pill Control | 92.86 | 7.14 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 24: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 60.00 | 40.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 46.15 | 15.38 | 23.08 | 7.69 | 7.69 |
,Placebo Pill Control | 83.33 | 16.67 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 24: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 50.00 | 30.00 | 10.00 | 0.00 | 10.00 |
,No Pill Control | 46.15 | 15.38 | 23.08 | 15.38 | 0.00 |
,Placebo Pill Control | 83.33 | 16.67 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 24: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 50.00 | 30.00 | 10.00 | 10.00 | 0.00 |
,No Pill Control | 53.85 | 15.38 | 15.38 | 15.38 | 0.00 |
,Placebo Pill Control | 83.33 | 8.33 | 8.33 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 24: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 50.00 | 10.00 | 10.00 | 10.00 | 20.00 |
,No Pill Control | 30.77 | 15.38 | 15.38 | 30.77 | 7.69 |
,Placebo Pill Control | 66.67 | 16.67 | 8.33 | 8.33 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 24: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 80.00 | 20.00 | 0.00 | 0.00 | 0.00 |
,No Pill Control | 53.85 | 23.08 | 23.08 | 0.00 | 0.00 |
,Placebo Pill Control | 91.67 | 0.00 | 0.00 | 8.33 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 4: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 57.89 | 26.32 | 15.79 | 0.00 | 0.00 |
,No Pill Control | 50.00 | 27.78 | 16.67 | 0.00 | 5.56 |
,Placebo Pill Control | 66.67 | 22.22 | 5.56 | 5.56 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 4: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 5.56 | 11.11 | 11.11 | 5.56 |
,No Pill Control | 55.56 | 11.11 | 16.67 | 16.67 | 0.00 |
,Placebo Pill Control | 55.56 | 27.78 | 5.56 | 5.56 | 5.56 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 8
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 8
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 14 |
Placebo Pill Control | 8 |
[back to top]
Number of Missed Doses Over Time Based on Self-Report Calendar Data
The outcome measure presents the least square means from the generalized linear model. The outcome here is a binary variable that determines whether the subject missed a dose or not. In a binomial model with logit link, the least squares means are predicted population margins of the logits. (NCT01033942)
Timeframe: 24 weeks
Intervention | Doses (Least Squares Mean) |
---|
FTC/TDF as PrEP | 0.4752 |
Placebo Pill Control | 0.4021 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Baseline
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Baseline
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 11 |
Placebo Pill Control | 11 |
No Pill Control | 12 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 24
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 24
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 17 |
Placebo Pill Control | 5.5 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 20
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 20
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 5 |
Placebo Pill Control | 10 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 16
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: Week 16
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 5 |
Placebo Pill Control | 19 |
[back to top]
Number of Missed Doses Based on Self-Report Calendar Data-Week 4
Missed doses were calculated as the number of days between the date that subject came in for their current visit and the last date the subject was dispensed medication minus the total number of days the subject records having taken their medication in the last 31 days based on self-report calendar data. Since each subject is given a 30 day supply of medication at each visit, any days after 30 days are assumed to be missed medication days and are included in the total. Participants were taking only one dose per day and thus, the number of missed doses is the same as the number of missed medication days. (NCT01033942)
Timeframe: 4 weeks
Intervention | Missed Doses (Median) |
---|
FTC/TDF as PrEP | 10 |
Placebo Pill Control | 10 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 12
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 12
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 13 |
Placebo Pill Control | 14 |
No Pill Control | 12 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 16
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 16
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 11 |
Placebo Pill Control | 13 |
No Pill Control | 12 |
[back to top]
Number of Participants Reporting No High-Risk Man With Man Sex Acts at Week 20
"A high-risk sex act was defined as an answer of greater than 0 to any of the following questions:~With your male HIV positive male partners during the past month:~How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom? How many times did you have insertive anal sex WITHOUT a condom? How many times did you have receptive anal sex WITHOUT a condom?" (NCT01033942)
Timeframe: Week 20
Intervention | participants (Number) |
---|
FTC/TDF as PrEP | 9 |
Placebo Pill Control | 11 |
No Pill Control | 10 |
[back to top]
Frequency of Missing Study Pills Because Participant Wanted to Avoid Side Effects
(NCT01033942)
Timeframe: 24 weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 82.35 | 9.41 | 0.00 | 8.24 |
,Placebo Pill Control | 91.40 | 3.23 | 2.15 | 3.23 |
[back to top]
Frequency of Missing Study Pills Because Participant Was Away From Home
(NCT01033942)
Timeframe: 24 Weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 31.76 | 34.12 | 16.47 | 17.65 |
,Placebo Pill Control | 48.39 | 20.43 | 26.88 | 4.30 |
[back to top]
Perceived HIV Risk Reduction at Week 4: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 63.16 | 5.26 | 10.53 | 21.05 | 0.00 |
,No Pill Control | 55.56 | 27.78 | 5.56 | 5.56 | 5.56 |
,Placebo Pill Control | 66.67 | 16.67 | 5.56 | 11.11 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 4: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 63.16 | 5.26 | 10.53 | 21.05 | 0.00 |
,No Pill Control | 44.44 | 5.56 | 22.22 | 22.22 | 5.56 |
,Placebo Pill Control | 50.00 | 16.67 | 0.00 | 27.78 | 5.56 |
[back to top]
Perceived HIV Risk Reduction at Week 4: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 84.21 | 5.26 | 10.53 | 0.00 | 0.00 |
,No Pill Control | 94.44 | 0.00 | 5.56 | 0.00 | 0.00 |
,Placebo Pill Control | 83.33 | 5.56 | 0.00 | 5.56 | 5.56 |
[back to top]
Perceived HIV Risk Reduction at Week 8: Less Concerned About Unprotected Anal Sex Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am less concerned about having unprotected anal sex now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 47.06 | 23.53 | 23.53 | 0.00 | 5.88 |
,No Pill Control | 35.29 | 41.18 | 23.53 | 0.00 | 0.00 |
,Placebo Pill Control | 83.33 | 11.11 | 5.56 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 8: Less Worried About 'Slipping up' Now That PrEP May be Taken Prior to Unprotected Sex
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am a lot less worried about 'slipping up' now that PrEP may be taken prior to unprotected sex." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 47.06 | 29.41 | 17.65 | 5.88 | 0.00 |
,No Pill Control | 35.29 | 35.29 | 11.76 | 17.65 | 0.00 |
,Placebo Pill Control | 66.67 | 5.56 | 27.78 | 0.00 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 8: Less Worried About Having Unprotected Sex Due to the Availability of PrEP
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: The availability of PrEP makes me less worried about having unprotected sex." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 58.82 | 17.65 | 17.65 | 0.00 | 5.88 |
,No Pill Control | 35.29 | 23.53 | 11.76 | 29.41 | 0.00 |
,Placebo Pill Control | 66.67 | 11.11 | 16.67 | 5.56 | 0.00 |
[back to top]
Perceived HIV Risk Reduction at Week 8: Participant Has Already Risked Getting HIV Infected Through Unprotected Sex While on This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I have already risked getting infected with HIV through unsafe sex while I've been in this study." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 52.94 | 5.88 | 17.65 | 5.88 | 17.65 |
,No Pill Control | 23.53 | 17.65 | 23.53 | 17.65 | 17.65 |
,Placebo Pill Control | 61.11 | 11.11 | 5.56 | 5.56 | 16.67 |
[back to top]
Perceived HIV Risk Reduction at Week 8: Willingness to Take a Chance of Getting HIV Infected Because Participating in This PrEP Study
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: I am more willing to take a chance of getting infected now that I am in this PrEP study." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 68.75 | 25.00 | 6.25 | 0.00 | 0.00 |
,No Pill Control | 64.71 | 29.41 | 5.88 | 0.00 | 0.00 |
,Placebo Pill Control | 100.00 | 0.00 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived Risk of Becoming HIV Positive at Week 12
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 12
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 40.00 | 40.00 | 20.00 | 0.00 | 0.00 |
,No Pill Control | 31.25 | 37.50 | 12.50 | 6.25 | 12.50 |
,Placebo Pill Control | 75.00 | 6.25 | 6.25 | 12.50 | 0.00 |
[back to top]
Perceived Risk of Becoming HIV Positive at Week 16
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 16
Intervention | percentage of partcipants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 58.33 | 16.67 | 8.33 | 8.33 | 8.33 |
,No Pill Control | 42.86 | 21.43 | 21.43 | 0.00 | 14.29 |
,Placebo Pill Control | 80.00 | 13.33 | 6.67 | 0.00 | 0.00 |
[back to top]
Perceived Risk of Becoming HIV Positive at Week 20
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 20
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 66.67 | 16.67 | 0.00 | 16.67 | 0.00 |
,No Pill Control | 30.77 | 23.08 | 23.08 | 7.69 | 15.38 |
,Placebo Pill Control | 78.57 | 21.43 | 0.00 | 0.00 | 0.00 |
[back to top]
Perceived Risk of Becoming HIV Positive at Week 24
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 24
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 60.00 | 20.00 | 0.00 | 10.00 | 10.00 |
,No Pill Control | 38.46 | 23.08 | 15.38 | 7.69 | 15.38 |
,Placebo Pill Control | 75.00 | 8.33 | 16.67 | 0.00 | 0.00 |
[back to top]
Perceived Risk of Becoming HIV Positive at Week 4
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 4
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 52.63 | 21.05 | 10.53 | 15.79 | 0.00 |
,No Pill Control | 33.33 | 22.22 | 27.78 | 0.00 | 16.67 |
,Placebo Pill Control | 38.89 | 33.33 | 11.11 | 11.11 | 5.56 |
[back to top]
Perceived Risk of Becoming HIV Positive at Week 8
"Participants were asked to state whether or not they strongly disagreed, disagreed, were neutral, agreed, or strongly agreed with the following statement: Because I am in this PrEP study, I am less concerned about becoming HIV positive." (NCT01033942)
Timeframe: Week 8
Intervention | percentage of participants (Number) |
---|
| Strongly Disagree | Disagree | Neutral | Agree | Strongly Agree |
---|
FTC/TDF as PrEP | 29.41 | 17.65 | 23.53 | 23.53 | 5.88 |
,No Pill Control | 58.82 | 11.76 | 11.76 | 11.76 | 5.88 |
,Placebo Pill Control | 66.67 | 27.78 | 0.00 | 5.56 | 0.00 |
[back to top]
Frequency of Missing Study Pills Because Participant Was Too Busy With Other Things
(NCT01033942)
Timeframe: 24 Weeks
Intervention | % of participants in each category (Number) |
---|
| Never | Rarely | Sometimes | Often |
---|
FTC/TDF as PrEP | 47.06 | 30.59 | 15.29 | 7.06 |
,Placebo Pill Control | 58.06 | 16.13 | 21.51 | 4.30 |
[back to top]
Number of Participants Who Thought They Were on Placebo vs. Pre-Exposure Prophylaxis (PrEP) at Week 12
(NCT01033942)
Timeframe: Week 12
Intervention | participants (Number) |
---|
| Placebo | PrEP | Don't Know | Don't Understand Question |
---|
FTC/TDF as PrEP | 6 | 3 | 5 | 0 |
,Placebo Pill Control | 6 | 2 | 8 | 0 |
[back to top]
Antepartum Component: Number of Mothers With Obstetrical Complications
"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
Intervention | Participants (Count of Participants) |
---|
| Periods 1 and 2 | Period 2 |
---|
Antepartum Arm A | 89 | 20 |
,Antepartum Arm B | 75 | 12 |
[back to top]
[back to top]
Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death
AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses in Appendix IV of the protocol. These events were reviewed and confirmed by an Endpoint review group. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | New cases per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 0.24 |
Maternal Health Arm B (Discontinue Triple ARVs) | 0.49 |
[back to top]
Maternal Health Component: Incidence of Tuberculosis
Incidence of tuberculosis. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | New cases per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 0.40 |
Maternal Health Arm B (Discontinue Triple ARVs) | 0.31 |
[back to top]
[back to top]
Antepartum Component: Number of Mothers With Obstetrical Complications
"Complications included deaths, diagnoses, signs/symptoms, chemistry lab tests, or hematological lab tests, with grades of 3 (Severe) or worse. Obstetrical complications were those classified by the MedDra coding system as Pregnancy, puerperium and perinatal conditions, except if the condition was the death of the fetus: Abortions not specified as induced or spontaneous, Abortions spontaneous, or Stillbirth and foetal death." (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
Intervention | Participants (Count of Participants) |
---|
| Period 2 |
---|
Antepartum Arm C | 23 |
[back to top]
Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
Intervention | Participants (Count of Participants) |
---|
| Periods 1 and 2 | Period 2 |
---|
Antepartum Arm A | 261 | 59 |
,Antepartum Arm B | 318 | 61 |
[back to top]
Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through the Week 1 postpartum study visit
Intervention | Participants (Count of Participants) |
---|
| Period 2 |
---|
Antepartum Arm C | 60 |
[back to top]
Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
Composite outcome (NCT01061151)
Timeframe: Measured at birth
Intervention | Participants (Count of Participants) |
---|
| Periods 1 and 2 | Period 2 |
---|
Antepartum Arm A | 389 | 91 |
,Antepartum Arm B | 563 | 123 |
[back to top]
Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies)
Composite outcome (NCT01061151)
Timeframe: Measured at birth
Intervention | Participants (Count of Participants) |
---|
| Period 2 |
---|
Antepartum Arm C | 111 |
[back to top]
Postpartum Component: Proportion of Mother-Infant Pairs With no Death or HIV Diagnosis Through 24 Months Post-delivery
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit, confirmed by HIV NAT positivity of a second specimen drawn at a different time point, or infant death. Analyses (Kaplan-Meier probabilities) were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through 24 months post-delivery
Intervention | Probability (Number) |
---|
Postpartum Arm A (Maternal Prophylaxis) | 0.971 |
Postpartum Arm B (Infant Prophylaxis) | 0.977 |
[back to top]
Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events
These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
Intervention | New cases per 100 person-years (Number) |
---|
Postpartum Arm A (Maternal Prophylaxis) | 14.4 |
Postpartum Arm B (Infant Prophylaxis) | 14.1 |
[back to top]
Postpartum Component: Incidence of Confirmed Infant HIV Infection
Defined as infant HIV NAT positivity of a specimen drawn at any post-randomization visit (i.e., any visit after the Week 1 [Day 6-14] visit), confirmed by HIV NAT positivity of a second specimen drawn at a different time point. Analyses were conducted at the Mother-Infant (M-I) pair level, hence the worst outcome for multiple births was counted as a single event. (NCT01061151)
Timeframe: Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first
Intervention | New cases per 100 person-years (Number) |
---|
Postpartum Arm A (Maternal Prophylaxis) | 0.56 |
Postpartum Arm B (Infant Prophylaxis) | 0.55 |
[back to top]
[back to top]
Maternal Health Component: Toxicity: Incidence of Grade 3 or Greater Laboratory Results or Signs and Symptoms and Selected Grade 2 Hematologic, Renal, and Hepatic Laboratory Results
The maternal safety endpoints summarized include grade 2, 3 or 4 hematologies (hemoglobin (Hb), White Blood Cells (WBC), Absolute Neutrophil Count (ANC), platelet count), chemistries (Alanine Aminotransferase (ALT or SGPT), serum creatinine), and grade 3 or 4 signs and symptoms that occurred post-randomization. These events were graded using the Division of AIDS (DAIDS) AE Grading Table, Version 1.0, December 2004, Clarification August 2009, which is available on the RSC website (http://rsc.tech-res.com). (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | New cases per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 15.3 |
Maternal Health Arm B (Discontinue Triple ARVs) | 13.9 |
[back to top]
Maternal Health Component: Other Targeted Medical Conditions
Other (non-cardiologic) medical conditions of particular concern were included in this outcome. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Events included were metabolic events, hepatic events, renal events, infections such as pulmonary tuberculosis, malaria, or other serious bacterial infections, and others. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | events per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 4.0 |
Maternal Health Arm B (Discontinue Triple ARVs) | 4.6 |
[back to top]
Maternal Health Component: Incidence Rate of Progression to AIDS-defining Illness, Death, or a Serious Non-AIDS Cardiovascular, Hepatic, or Renal Event
"This outcome included AIDS-defining illnesses or cardiovascular, hepatic, or renal adverse events of particular concern which were evaluated as serious. Serious outcomes were both those defined as serious according to the International Conference on Harmonization (ICH) definition, or outcomes with grades equal to or worse than 3 (Severe). A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. Cardiovascular events considered were hypertension, congestive heart failure, stroke, Transient Ischemia Event (TIA), pulmonary embolism, myocardial infarction (whether acute symptomatic or silent), coronary artery disease, deep vein thrombosis, peripheral vascular disease, or symptomatic HIV-associated cardiomyopathy. Hepatic events considered were cirrhosis and idiopathic sclerosing cholangitis. Renal events considered were renal insufficiency, acute or chronic." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | events per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 0.5 |
Maternal Health Arm B (Discontinue Triple ARVs) | 0.9 |
[back to top]
Maternal Health Component: Incidence Rate of Death or Any Condition of Particular Concern
Particular events were targeted as those of particular concern. This outcome considered all such events: death, events defining WHO stages II, III, or IV, targeted cardiovascular adverse events, other targeted adverse events, or cancers which were not AIDS-defining. A complete list can be found in Appendix IV of the Protocol. A Poisson model with time to first event as an offset and an over-dispersion parameter was used to estimate incidence rates. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | events per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 9.0 |
Maternal Health Arm B (Discontinue Triple ARVs) | 14.0 |
[back to top]
[back to top]
Maternal Health Component: Incidence of Death
Number of women who died during the maternal health component; that is, who had been randomized to either continue or discontinue ART after risk of HIV vertical transmission through breastfeeding was over. (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | New cases per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 0.24 |
Maternal Health Arm B (Discontinue Triple ARVs) | 0.43 |
[back to top]
Maternal Health Component: Incidence of AIDS-defining Illness
"AIDS-defining illness refers to the WHO Clinical Stage 4 illnesses listed in Appendix IV. Stage 4 illnesses were reviewed and confirmed by an Endpoint review group." (NCT01061151)
Timeframe: From study entry until July 7, 2015, an average of 94 weeks of follow-up.
Intervention | New cases per 100 person-years (Number) |
---|
Maternal Health Arm A (Continue Triple ARVs) | 0.08 |
Maternal Health Arm B (Discontinue Triple ARVs) | 0.25 |
[back to top]
Antepartum Component: Number of Infant HIV Infections
Detected by HIV NAT positivity (NCT01061151)
Timeframe: Measured at the birth (<= 3 days postpartum) visit
Intervention | Participants (Count of Participants) |
---|
Antepartum Arm A | 22 |
Antepartum Arm B | 4 |
Antepartum Arm C | 2 |
[back to top]
Antepartum Component: Number of Confirmed Infant HIV Infections
Defined as HIV nucleic acid test (NAT) positivity of the specimen drawn at either the birth (Day 0-5) or Week 1 (Day 6-14) visit, confirmed by HIV NAT positivity of a second specimen collected at a different time point (NCT01061151)
Timeframe: Measured at birth or Week 1 study visit
Intervention | Participants (Count of Participants) |
---|
Antepartum Arm A | 25 |
Antepartum Arm B | 7 |
Antepartum Arm C | 2 |
[back to top]
Postpartum Component: Adherence to the Maternal and/or Infant ARV Regimens, as Measured by Maternal Report and Hair Measures
"Adherence is by maternal report; adherence through hair analysis is not included here.~The protocol did not distinguish between outcomes essential to the primary publication and outcomes for subsequent publications of lesser priority. This outcome measure was listed as secondary in the protocol but the intention was as an exploratory outcome since adherence was not a focus of the study." (NCT01061151)
Timeframe: Week 6 visit (14 days - 9 weeks postpartum); Week 14 visit (10-19 weeks postpartum); Week 26 visit (20 to 31 weeks postpartum); Week 50 visit (44 to 55 weeks postpartum); and Week 74 visit (68 to 80 weeks postpartum).
Intervention | Participants (Count of Participants) |
---|
| Week 6 visit72329524 | Week 6 visit72329525 | Week 14 visit72329524 | Week 14 visit72329525 | Week 26 visit72329524 | Week 26 visit72329525 | Week 50 visit72329524 | Week 50 visit72329525 | Week 74 visit72329524 | Week 74 visit72329525 |
---|
| Missed dose over 1 month ago | Never missed a dose | Missed dose 2-4 weeks ago | Missed dose within last 2 weeks |
---|
Postpartum Arm A (Maternal Prophylaxis) | 1003 |
Postpartum Arm B (Infant Prophylaxis) | 1104 |
Postpartum Arm A (Maternal Prophylaxis) | 12 |
Postpartum Arm A (Maternal Prophylaxis) | 17 |
Postpartum Arm B (Infant Prophylaxis) | 4 |
Postpartum Arm A (Maternal Prophylaxis) | 140 |
Postpartum Arm B (Infant Prophylaxis) | 74 |
Postpartum Arm A (Maternal Prophylaxis) | 956 |
Postpartum Arm B (Infant Prophylaxis) | 1081 |
Postpartum Arm A (Maternal Prophylaxis) | 20 |
Postpartum Arm B (Infant Prophylaxis) | 0 |
Postpartum Arm A (Maternal Prophylaxis) | 35 |
Postpartum Arm A (Maternal Prophylaxis) | 112 |
Postpartum Arm B (Infant Prophylaxis) | 50 |
Postpartum Arm A (Maternal Prophylaxis) | 888 |
Postpartum Arm B (Infant Prophylaxis) | 1035 |
Postpartum Arm A (Maternal Prophylaxis) | 48 |
Postpartum Arm A (Maternal Prophylaxis) | 31 |
Postpartum Arm B (Infant Prophylaxis) | 8 |
Postpartum Arm A (Maternal Prophylaxis) | 103 |
Postpartum Arm B (Infant Prophylaxis) | 47 |
Postpartum Arm A (Maternal Prophylaxis) | 716 |
Postpartum Arm B (Infant Prophylaxis) | 841 |
Postpartum Arm A (Maternal Prophylaxis) | 37 |
Postpartum Arm A (Maternal Prophylaxis) | 34 |
Postpartum Arm B (Infant Prophylaxis) | 7 |
Postpartum Arm A (Maternal Prophylaxis) | 64 |
Postpartum Arm B (Infant Prophylaxis) | 30 |
Postpartum Arm A (Maternal Prophylaxis) | 311 |
Postpartum Arm B (Infant Prophylaxis) | 377 |
Postpartum Arm A (Maternal Prophylaxis) | 15 |
Postpartum Arm B (Infant Prophylaxis) | 2 |
Postpartum Arm B (Infant Prophylaxis) | 1 |
Postpartum Arm B (Infant Prophylaxis) | 9 |
[back to top]
Antepartum Component: Maternal HIV RNA Less Than 400 Copies/mL at Delivery
Analysis used the principle of intent to treat. (NCT01061151)
Timeframe: Measured at the time of delivery
Intervention | Participants (Count of Participants) | Participants (Count of Participants) |
---|
| Periods 1 and 272329519 | Periods 1 and 272329520 | Period 272329520 | Period 272329519 | Period 272329521 |
---|
| HIV RNA < 400 copies/mL | HIV RNA >= 400 copies/mL |
---|
Antepartum Arm A | 415 |
Antepartum Arm B | 1092 |
Antepartum Arm A | 929 |
Antepartum Arm B | 275 |
Antepartum Arm A | 102 |
Antepartum Arm B | 259 |
Antepartum Arm C | 225 |
Antepartum Arm A | 210 |
Antepartum Arm B | 62 |
Antepartum Arm C | 79 |
[back to top]
Postpartum Component: Proportion of Infants Alive Through 12 and 24 Months Post-delivery
Analyses (Kaplan-Meier probabilities) conducted for all individual infants (rather than M-I pair) (NCT01061151)
Timeframe: Measured at 12 and 24 months post-delivery
Intervention | Probability (Number) |
---|
| 12 months post delivery | 24 months post delivery |
---|
Postpartum Arm A (Maternal Prophylaxis) | 0.988 | 0.978 |
,Postpartum Arm B (Infant Prophylaxis) | 0.989 | 0.987 |
[back to top]
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age
Intervention | Proportional probability (Number) |
---|
| Overall survival, Periods 1 & 2 group (arms A & B only) | Overall survival, period 2 group | HIV-free survival, Periods 1&2 group (arms A&B only) | HIV-free survival, period 2 group |
---|
Antepartum Arm A | 0.959 | 0.951 | 0.937 | 0.936 |
,Antepartum Arm B | 0.967 | 0.982 | 0.947 | 0.940 |
[back to top]
Antepartum Component: Probability of Overall and HIV-free Infant Survival Until 104 Weeks of Age, by Antepartum Arm (in Conjunction With Infants in the Postpartum Component)
For overall survival, failure was defined to be death. For HIV-free survival, failure was defined to be either death or developing HIV. The probability of living, or living without HIV infection, at 104 weeks was calculated by Kaplan-Meier estimation of the survival function. (NCT01061151)
Timeframe: Measured from birth through 104 weeks of age
Intervention | Proportional probability (Number) |
---|
| Overall survival, period 2 group | HIV-free survival, period 2 group |
---|
Antepartum Arm C | 0.942 | 0.921 |
[back to top]
Course Completion
PEP course completion is a dichotomous variable (0 = Not completed; 1 = Completed) that indicates whether the participant maintained sufficient adherence to the Truvada regimen to receive all 28 doses of the medication. Note: Missing 3 Truvada doses in a row terminated the PEP-intervention and prevented Course Completion. (NCT01140880)
Timeframe: 28-days post initiation
Intervention | participants (Number) |
---|
Contingency Management | 12 |
Yoked Contingency Management | 4 |
[back to top]
Abstinence From Stimulant Drug Use (Cocaine, Amphetamine, Methamphetamine)
Abstinence will be measured using thrice weekly urine drug screens and self-report (NCT01140880)
Timeframe: Thrice-weekly for 8 weeks
Intervention | Stimulant-free urinalyses (Mean) |
---|
Contingency Management | 8.9 |
Yoked Contingency Management | 6.0 |
[back to top]
Time From Exposure to Truvada Initiation
Time to initiation is defined as the number of hours between exposure to viral inoculum and initiation of the Truvada medication regimen. (NCT01140880)
Timeframe: 6-month follow-up
Intervention | hours (Mean) |
---|
Contingency Management | 32.8 |
Yoked Contingency Management | 33.0 |
[back to top]
Medication Adherence
Adherence to Truvada medication (if initiated) as assessed by self-report and pill count. (NCT01140880)
Timeframe: Daily throughout medication course
Intervention | proportion (Number) |
---|
Contingency Management | 0.75 |
Yoked Contingency Management | 0.45 |
[back to top]
Change in Proviral HIV-1 DNA in Total CD4+ T-cells From Baseline to Week 48 in Participants Randomized to the Intensified Arm Versus the Control Arm Who Received Placebo in Addition to Standard HAART.
The level of HIV Provirus in CD4 T cells obtained from peripheral blood at 48 weeks compared to baseline. A quantitative HIV PCR assay was done. The mean/median values from the standard HAART group is compared to the intensive HAART treatment regimen. (NCT01154673)
Timeframe: Baseline to Week 48
Intervention | HIV DNA copies/ million CD4 cells (Median) |
---|
Intensive HAART | 279 |
Placebo Arm | 244 |
[back to top]
The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 12 Weeks on Treatment
"The rate of neuropsychiatric and central nervous system (CNS) toxicity as measured after 12 weeks of raltegravir therapy as measured by :~Sleep questionnaire~CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale)" (NCT01195467)
Timeframe: baseline to week 12
Intervention | percentage of improvement in sleep score (Number) |
---|
Single Arm | 25 |
[back to top]
The Rate of Neuropsychiatric and Central Nervous System (CNS) Toxicity of Raltegravir Therapy After 4 Weeks on Treatment
To assess the rate of neuropsychiatric and central nervous system (CNS) toxicity as measured from baseline to 4 weeks of raltegravir therapy as measured by sleep questionnaire & CNS toxicity (as determined by questionnaire based on efavirenz SPC and graded based on the ACTG adverse event scale) (NCT01195467)
Timeframe: 4 weeks
Intervention | percentage improvement in CNS score (Number) |
---|
Single Arm | 26 |
[back to top]
Safety and Tolerability as Assessed by the Number of Participants Who Completed the 28-day Course of the Antiretroviral Drugs Being Explored in This Study
(NCT01214759)
Timeframe: 28 days
Intervention | participants (Number) |
---|
Truvada and Raltegravir | 85 |
[back to top]
Efficacy as Assessed by the Number of Participants Who Were HIV Positive at 6 Months
This measure assesses whether the combination of Truvada and Raltegravir prevents the acquisition of HIV at six months among HIV-negative people who have been exposed to HIV. (NCT01214759)
Timeframe: 6 months
Intervention | participants (Number) |
---|
Truvada and Raltegravir | 0 |
[back to top]
[back to top]
Change in Serum Levels of Vitamin D
Change in serum levels of 24-OH-vitamin D provide a measure of the amount of change in vitamin D in the body (NCT01270802)
Timeframe: Baseline and 24 weeks
Intervention | ng/mL (Mean) |
---|
Continued Tenofovir/Emtricitabine/Efavirenz | 0.06 |
Switch to Tenofovir/Emtricitabine Plus Raltegravir | 0.14 |
[back to top]
HCV RNA
HCV RNA determined by reverse transcription polymerase chain reaction and measured as log IU/ml 48 hours after a single dose of peginterferon alfa 2b 1.5 μg/kg. (NCT01285050)
Timeframe: 48 hours after interferon administration
Intervention | log IU/ml (Median) |
---|
Pre ART HCV RNA Decline | 0.65 |
Post ART HCV Decline | 0.81 |
[back to top]
The Total Pills Actually Used Over the Follow-up Period
The total pills actually used over the follow-up period was calculated based on the adjusted electronic and self-reported pill-use data. It could be more or less than required by study design (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Number of pills actually used (Number) |
---|
Daily Dosing, Cape Town | 7349 |
Time-driven Dosing, Cape Town | 2852 |
Event-driven Dosing, Cape Town | 2000 |
Daily Dosing, Bangkok | 8285 |
Time-driven Dosing, Bangkok | 3713 |
Event-driven Dosing, Bangkok | 2157 |
Daily Dosing, Harlem | 5507 |
Time-driven Dosing, Harlem | 2468 |
Event-driven Dosing, Harlem | 2356 |
[back to top]
The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data
(NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | % of Correctly Timed Adherence (Number) |
---|
Daily Dosing, Cape Town | 75 |
Time-driven Dosing, Cape Town | 65 |
Event-driven Dosing, Cape Town | 53 |
Daily Dosing, Bangkok | 85 |
Time-driven Dosing, Bangkok | 79 |
Event-driven Dosing, Bangkok | 65 |
Daily Dosing, Harlem | 65 |
Time-driven Dosing, Harlem | 47 |
Event-driven Dosing, Harlem | 41 |
[back to top]
The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)
"Below I reported the number of sex acts as reported based on the adjusted electronic and self-reported sexual activity data, also the number of pills needed for 100% coverage. 100% coverage means all sex events (excluding oral sex) are covered; Note: sex act is considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity (same coverage definition for all three arms)" (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Number of pills needed for 100% coverage (Number) |
---|
Daily Dosing, Cape Town | 2097 |
Time-driven Dosing, Cape Town | 1552 |
Event-driven Dosing, Cape Town | 1906 |
Daily Dosing, Bangkok | 1746 |
Time-driven Dosing, Bangkok | 1573 |
Event-driven Dosing, Bangkok | 1268 |
Daily Dosing, Harlem | 1244 |
Time-driven Dosing, Harlem | 1390 |
Event-driven Dosing, Harlem | 1582 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #6 | 2100 | 3710 | 127480 | 220830 | 193130 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the cross table between drug resistance by arm are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels, and outcome measure 12 for the listing of drug resistance test by arm among all participants who seroconvert while on study. (NCT01327651)
Timeframe: From enrollment to week 30 (end of self-administered dosing)
Intervention | Participants (Count of Participants) |
---|
| Before Randomization72291147 | Before Randomization72291146 | Before Randomization72291148 | After Randomization (Daily dosing)72291146 | After Randomization (Daily dosing)72291147 | After Randomization (Daily dosing)72291148 | After Randomization (Time-driven dosing)72291147 | After Randomization (Time-driven dosing)72291146 | After Randomization (Time-driven dosing)72291148 | After Randomization (Event-driven dosing)72291147 | After Randomization (Event-driven dosing)72291146 | After Randomization (Event-driven dosing)72291148 |
---|
| Drug Resistance | No Drug Resistance |
---|
Cape Town, South Africa | 1 |
Bangkok, Thailand | 0 |
Harlem, United States | 1 |
Cape Town, South Africa | 190 |
Bangkok, Thailand | 193 |
Harlem, United States | 237 |
Harlem, United States | 0 |
Cape Town, South Africa | 59 |
Bangkok, Thailand | 60 |
Harlem, United States | 59 |
Cape Town, South Africa | 58 |
Harlem, United States | 60 |
Cape Town, South Africa | 0 |
Cape Town, South Africa | 60 |
Bangkok, Thailand | 59 |
[back to top]
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of adverse events (AEs) by grade and arm are presented here. See outcome measure 10 for the listing of AE by relationship to study product (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Participants (Count of Participants) |
---|
| Blood and lymphatic system disorders : Mild72291137 | Blood and lymphatic system disorders : Mild72291143 | Blood and lymphatic system disorders : Mild72291138 | Blood and lymphatic system disorders : Mild72291139 | Blood and lymphatic system disorders : Mild72291140 | Blood and lymphatic system disorders : Mild72291141 | Blood and lymphatic system disorders : Mild72291142 | Blood and lymphatic system disorders : Mild72291144 | Blood and lymphatic system disorders : Mild72291145 | Cardiac disorders72291137 | Cardiac disorders72291143 | Cardiac disorders72291138 | Cardiac disorders72291139 | Cardiac disorders72291140 | Cardiac disorders72291141 | Cardiac disorders72291142 | Cardiac disorders72291144 | Cardiac disorders72291145 | Ear and labyrinth disorders72291137 | Ear and labyrinth disorders72291143 | Ear and labyrinth disorders72291144 | Ear and labyrinth disorders72291142 | Ear and labyrinth disorders72291138 | Ear and labyrinth disorders72291139 | Ear and labyrinth disorders72291140 | Ear and labyrinth disorders72291141 | Ear and labyrinth disorders72291145 | Eye disorders72291137 | Eye disorders72291143 | Eye disorders72291138 | Eye disorders72291139 | Eye disorders72291140 | Eye disorders72291141 | Eye disorders72291142 | Eye disorders72291144 | Eye disorders72291145 | Gastrointestinal disorders72291137 | Gastrointestinal disorders72291143 | Gastrointestinal disorders72291142 | Gastrointestinal disorders72291138 | Gastrointestinal disorders72291139 | Gastrointestinal disorders72291140 | Gastrointestinal disorders72291141 | Gastrointestinal disorders72291144 | Gastrointestinal disorders72291145 | General disorders and administration site conditio72291137 | General disorders and administration site conditio72291142 | General disorders and administration site conditio72291143 | General disorders and administration site conditio72291140 | General disorders and administration site conditio72291138 | General disorders and administration site conditio72291139 | General disorders and administration site conditio72291141 | General disorders and administration site conditio72291144 | General disorders and administration site conditio72291145 | Hepatobiliary disorders72291137 | Hepatobiliary disorders72291142 | Hepatobiliary disorders72291143 | Hepatobiliary disorders72291138 | Hepatobiliary disorders72291139 | Hepatobiliary disorders72291140 | Hepatobiliary disorders72291141 | Hepatobiliary disorders72291144 | Hepatobiliary disorders72291145 | Immune system disorders72291137 | Immune system disorders72291142 | Immune system disorders72291143 | Immune system disorders72291138 | Immune system disorders72291139 | Immune system disorders72291140 | Immune system disorders72291141 | Immune system disorders72291144 | Immune system disorders72291145 | Infections and infestations72291137 | Infections and infestations72291142 | Infections and infestations72291143 | Infections and infestations72291138 | Infections and infestations72291139 | Infections and infestations72291140 | Infections and infestations72291141 | Infections and infestations72291144 | Infections and infestations72291145 | Injury, poisoning and procedural complications72291137 | Injury, poisoning and procedural complications72291142 | Injury, poisoning and procedural complications72291138 | Injury, poisoning and procedural complications72291139 | Injury, poisoning and procedural complications72291140 | Injury, poisoning and procedural complications72291141 | Injury, poisoning and procedural complications72291143 | Injury, poisoning and procedural complications72291144 | Injury, poisoning and procedural complications72291145 | Investigations72291137 | Investigations72291142 | Investigations72291138 | Investigations72291139 | Investigations72291140 | Investigations72291141 | Investigations72291143 | Investigations72291144 | Investigations72291145 | Metabolism and nutrition disorders72291137 | Metabolism and nutrition disorders72291142 | Metabolism and nutrition disorders72291141 | Metabolism and nutrition disorders72291138 | Metabolism and nutrition disorders72291139 | Metabolism and nutrition disorders72291140 | Metabolism and nutrition disorders72291143 | Metabolism and nutrition disorders72291144 | Metabolism and nutrition disorders72291145 | Musculoskeletal and connective tissue disorders72291137 | Musculoskeletal and connective tissue disorders72291142 | Musculoskeletal and connective tissue disorders72291138 | Musculoskeletal and connective tissue disorders72291139 | Musculoskeletal and connective tissue disorders72291140 | Musculoskeletal and connective tissue disorders72291141 | Musculoskeletal and connective tissue disorders72291143 | Musculoskeletal and connective tissue disorders72291144 | Musculoskeletal and connective tissue disorders72291145 | Nervous system disorders72291137 | Nervous system disorders72291142 | Nervous system disorders72291141 | Nervous system disorders72291138 | Nervous system disorders72291139 | Nervous system disorders72291140 | Nervous system disorders72291143 | Nervous system disorders72291144 | Nervous system disorders72291145 | Pregnancy, puerperium and perinatal conditions72291137 | Pregnancy, puerperium and perinatal conditions72291142 | Pregnancy, puerperium and perinatal conditions72291140 | Pregnancy, puerperium and perinatal conditions72291144 | Pregnancy, puerperium and perinatal conditions72291141 | Pregnancy, puerperium and perinatal conditions72291138 | Pregnancy, puerperium and perinatal conditions72291139 | Pregnancy, puerperium and perinatal conditions72291143 | Pregnancy, puerperium and perinatal conditions72291145 | Psychiatric disorders72291141 | Psychiatric disorders72291142 | Psychiatric disorders72291137 | Psychiatric disorders72291144 | Psychiatric disorders72291143 | Psychiatric disorders72291138 | Psychiatric disorders72291139 | Psychiatric disorders72291140 | Psychiatric disorders72291145 | Renal and urinary disorders72291137 | Renal and urinary disorders72291142 | Renal and urinary disorders72291139 | Renal and urinary disorders72291138 | Renal and urinary disorders72291140 | Renal and urinary disorders72291141 | Renal and urinary disorders72291143 | Renal and urinary disorders72291144 | Renal and urinary disorders72291145 | Reproductive system and breast disorders72291137 | Reproductive system and breast disorders72291140 | Reproductive system and breast disorders72291142 | Reproductive system and breast disorders72291138 | Reproductive system and breast disorders72291139 | Reproductive system and breast disorders72291143 | Reproductive system and breast disorders72291145 | Reproductive system and breast disorders72291141 | Reproductive system and breast disorders72291144 | Respiratory, thoracic and mediastinal disorders72291137 | Respiratory, thoracic and mediastinal disorders72291142 | Respiratory, thoracic and mediastinal disorders72291145 | Respiratory, thoracic and mediastinal disorders72291140 | Respiratory, thoracic and mediastinal disorders72291138 | Respiratory, thoracic and mediastinal disorders72291139 | Respiratory, thoracic and mediastinal disorders72291141 | Respiratory, thoracic and mediastinal disorders72291143 | Respiratory, thoracic and mediastinal disorders72291144 | Skin and subcutaneous tissue disorders72291137 | Skin and subcutaneous tissue disorders72291138 | Skin and subcutaneous tissue disorders72291142 | Skin and subcutaneous tissue disorders72291140 | Skin and subcutaneous tissue disorders72291139 | Skin and subcutaneous tissue disorders72291141 | Skin and subcutaneous tissue disorders72291143 | Skin and subcutaneous tissue disorders72291144 | Skin and subcutaneous tissue disorders72291145 | Social circumstances72291142 | Social circumstances72291145 | Social circumstances72291137 | Social circumstances72291138 | Social circumstances72291139 | Social circumstances72291140 | Social circumstances72291141 | Social circumstances72291143 | Social circumstances72291144 | Vascular disorders72291142 | Vascular disorders72291137 | Vascular disorders72291141 | Vascular disorders72291140 | Vascular disorders72291144 | Vascular disorders72291138 | Vascular disorders72291139 | Vascular disorders72291143 | Vascular disorders72291145 | Neoplasms benign, malignant, and unspecified72291144 | Neoplasms benign, malignant, and unspecified72291139 | Neoplasms benign, malignant, and unspecified72291141 | Neoplasms benign, malignant, and unspecified72291138 | Neoplasms benign, malignant, and unspecified72291140 | Neoplasms benign, malignant, and unspecified72291143 | Neoplasms benign, malignant, and unspecified72291137 | Neoplasms benign, malignant, and unspecified72291142 | Neoplasms benign, malignant, and unspecified72291145 |
---|
| Severe | Potentically Life Threatening | Death | None | Mild | Moderate |
---|
Daily Dosing, Cape Town | 1 |
Time-driven Dosing, Harlem | 2 |
Daily Dosing, Cape Town | 0 |
Daily Dosing, Cape Town | 57 |
Time-driven Dosing, Harlem | 58 |
Daily Dosing, Cape Town | 59 |
Daily Dosing, Bangkok | 58 |
Time-driven Dosing, Harlem | 60 |
Time-driven Dosing, Harlem | 0 |
Daily Dosing, Cape Town | 58 |
Daily Dosing, Cape Town | 2 |
Daily Dosing, Cape Town | 55 |
Time-driven Dosing, Cape Town | 57 |
Event-driven Dosing, Harlem | 58 |
Daily Dosing, Cape Town | 18 |
Event-driven Dosing, Cape Town | 18 |
Time-driven Dosing, Bangkok | 22 |
Event-driven Dosing, Bangkok | 23 |
Daily Dosing, Harlem | 28 |
Time-driven Dosing, Harlem | 27 |
Event-driven Dosing, Harlem | 28 |
Daily Dosing, Cape Town | 8 |
Time-driven Dosing, Cape Town | 9 |
Daily Dosing, Bangkok | 6 |
Event-driven Dosing, Bangkok | 0 |
Daily Dosing, Cape Town | 33 |
Time-driven Dosing, Cape Town | 32 |
Event-driven Dosing, Cape Town | 32 |
Daily Dosing, Bangkok | 30 |
Time-driven Dosing, Bangkok | 35 |
Event-driven Dosing, Bangkok | 32 |
Daily Dosing, Harlem | 30 |
Time-driven Dosing, Harlem | 31 |
Event-driven Dosing, Harlem | 31 |
Daily Dosing, Cape Town | 9 |
Daily Dosing, Bangkok | 10 |
Time-driven Dosing, Bangkok | 16 |
Event-driven Dosing, Bangkok | 11 |
Event-driven Dosing, Harlem | 8 |
Event-driven Dosing, Cape Town | 5 |
Event-driven Dosing, Bangkok | 1 |
Daily Dosing, Cape Town | 50 |
Time-driven Dosing, Bangkok | 43 |
Event-driven Dosing, Bangkok | 47 |
Time-driven Dosing, Cape Town | 58 |
Time-driven Dosing, Bangkok | 58 |
Event-driven Dosing, Bangkok | 59 |
Event-driven Dosing, Cape Town | 58 |
Time-driven Dosing, Bangkok | 59 |
Time-driven Dosing, Harlem | 59 |
Event-driven Dosing, Harlem | 59 |
Daily Dosing, Cape Town | 11 |
Time-driven Dosing, Cape Town | 10 |
Event-driven Dosing, Cape Town | 15 |
Daily Dosing, Bangkok | 22 |
Time-driven Dosing, Bangkok | 33 |
Event-driven Dosing, Bangkok | 28 |
Daily Dosing, Harlem | 22 |
Time-driven Dosing, Harlem | 21 |
Event-driven Dosing, Harlem | 21 |
Daily Dosing, Cape Town | 25 |
Time-driven Dosing, Cape Town | 25 |
Event-driven Dosing, Cape Town | 21 |
Time-driven Dosing, Bangkok | 6 |
Event-driven Dosing, Bangkok | 10 |
Event-driven Dosing, Bangkok | 2 |
Daily Dosing, Cape Town | 23 |
Time-driven Dosing, Cape Town | 24 |
Event-driven Dosing, Cape Town | 24 |
Daily Dosing, Bangkok | 27 |
Time-driven Dosing, Bangkok | 19 |
Event-driven Dosing, Bangkok | 19 |
Daily Dosing, Harlem | 37 |
Time-driven Dosing, Harlem | 39 |
Event-driven Dosing, Harlem | 37 |
Daily Dosing, Cape Town | 7 |
Daily Dosing, Bangkok | 16 |
Time-driven Dosing, Bangkok | 15 |
Event-driven Dosing, Bangkok | 14 |
Daily Dosing, Harlem | 17 |
Time-driven Dosing, Harlem | 18 |
Event-driven Dosing, Harlem | 14 |
Daily Dosing, Cape Town | 3 |
Daily Dosing, Cape Town | 48 |
Daily Dosing, Bangkok | 44 |
Time-driven Dosing, Bangkok | 41 |
Event-driven Dosing, Bangkok | 44 |
Daily Dosing, Harlem | 38 |
Event-driven Dosing, Harlem | 45 |
Daily Dosing, Cape Town | 13 |
Time-driven Dosing, Cape Town | 15 |
Event-driven Dosing, Cape Town | 13 |
Daily Dosing, Bangkok | 18 |
Time-driven Dosing, Bangkok | 9 |
Event-driven Dosing, Bangkok | 7 |
Event-driven Dosing, Harlem | 6 |
Daily Dosing, Cape Town | 5 |
Time-driven Dosing, Cape Town | 6 |
Daily Dosing, Bangkok | 5 |
Time-driven Dosing, Bangkok | 2 |
Event-driven Dosing, Bangkok | 3 |
Event-driven Dosing, Harlem | 2 |
Daily Dosing, Cape Town | 41 |
Time-driven Dosing, Cape Town | 38 |
Daily Dosing, Bangkok | 35 |
Time-driven Dosing, Bangkok | 47 |
Event-driven Dosing, Bangkok | 48 |
Daily Dosing, Harlem | 50 |
Event-driven Dosing, Cape Town | 7 |
Time-driven Dosing, Bangkok | 1 |
Daily Dosing, Harlem | 3 |
Daily Dosing, Cape Town | 6 |
Event-driven Dosing, Cape Town | 10 |
Time-driven Dosing, Harlem | 3 |
Event-driven Dosing, Harlem | 4 |
Time-driven Dosing, Bangkok | 0 |
Time-driven Dosing, Cape Town | 49 |
Event-driven Dosing, Cape Town | 43 |
Event-driven Dosing, Bangkok | 58 |
Daily Dosing, Harlem | 52 |
Time-driven Dosing, Harlem | 53 |
Daily Dosing, Bangkok | 13 |
Event-driven Dosing, Bangkok | 13 |
Daily Dosing, Harlem | 13 |
Time-driven Dosing, Harlem | 11 |
Event-driven Dosing, Harlem | 9 |
Daily Dosing, Bangkok | 4 |
Time-driven Dosing, Cape Town | 51 |
Daily Dosing, Bangkok | 43 |
Time-driven Dosing, Harlem | 49 |
Event-driven Dosing, Harlem | 51 |
Daily Dosing, Cape Town | 17 |
Time-driven Dosing, Cape Town | 14 |
Event-driven Dosing, Cape Town | 19 |
Daily Dosing, Bangkok | 17 |
Time-driven Dosing, Bangkok | 18 |
Event-driven Dosing, Bangkok | 22 |
Daily Dosing, Harlem | 16 |
Time-driven Dosing, Harlem | 10 |
Event-driven Dosing, Harlem | 17 |
Daily Dosing, Cape Town | 15 |
Event-driven Dosing, Cape Town | 12 |
Daily Dosing, Bangkok | 3 |
Daily Dosing, Cape Town | 27 |
Event-driven Dosing, Cape Town | 29 |
Daily Dosing, Bangkok | 39 |
Event-driven Dosing, Bangkok | 36 |
Daily Dosing, Harlem | 42 |
Time-driven Dosing, Harlem | 47 |
Event-driven Dosing, Harlem | 43 |
Time-driven Dosing, Bangkok | 10 |
Event-driven Dosing, Bangkok | 8 |
Daily Dosing, Harlem | 10 |
Time-driven Dosing, Harlem | 9 |
Event-driven Dosing, Cape Town | 2 |
Time-driven Dosing, Harlem | 1 |
Time-driven Dosing, Cape Town | 56 |
Event-driven Dosing, Cape Town | 56 |
Daily Dosing, Bangkok | 52 |
Time-driven Dosing, Bangkok | 49 |
Event-driven Dosing, Bangkok | 51 |
Daily Dosing, Harlem | 46 |
Time-driven Dosing, Harlem | 48 |
Daily Dosing, Cape Town | 10 |
Time-driven Dosing, Cape Town | 11 |
Event-driven Dosing, Cape Town | 11 |
Daily Dosing, Bangkok | 1 |
Time-driven Dosing, Bangkok | 3 |
Daily Dosing, Harlem | 12 |
Time-driven Dosing, Harlem | 6 |
Event-driven Dosing, Harlem | 7 |
Daily Dosing, Cape Town | 4 |
Event-driven Dosing, Cape Town | 3 |
Time-driven Dosing, Harlem | 4 |
Event-driven Dosing, Harlem | 1 |
Daily Dosing, Cape Town | 45 |
Time-driven Dosing, Cape Town | 46 |
Event-driven Dosing, Cape Town | 46 |
Daily Dosing, Bangkok | 59 |
Time-driven Dosing, Bangkok | 55 |
Event-driven Dosing, Bangkok | 56 |
Daily Dosing, Harlem | 47 |
Time-driven Dosing, Harlem | 50 |
Event-driven Dosing, Harlem | 52 |
Time-driven Dosing, Cape Town | 17 |
Event-driven Dosing, Cape Town | 17 |
Daily Dosing, Harlem | 1 |
Event-driven Dosing, Harlem | 3 |
Daily Dosing, Cape Town | 39 |
Time-driven Dosing, Cape Town | 34 |
Event-driven Dosing, Cape Town | 34 |
Event-driven Dosing, Bangkok | 57 |
Daily Dosing, Harlem | 58 |
Event-driven Dosing, Harlem | 57 |
Time-driven Dosing, Cape Town | 5 |
Event-driven Dosing, Cape Town | 9 |
Daily Dosing, Bangkok | 36 |
Time-driven Dosing, Bangkok | 23 |
Event-driven Dosing, Bangkok | 29 |
Daily Dosing, Harlem | 18 |
Time-driven Dosing, Harlem | 19 |
Event-driven Dosing, Harlem | 18 |
Time-driven Dosing, Cape Town | 2 |
Daily Dosing, Cape Town | 49 |
Time-driven Dosing, Cape Town | 52 |
Event-driven Dosing, Cape Town | 50 |
Daily Dosing, Bangkok | 24 |
Time-driven Dosing, Bangkok | 36 |
Daily Dosing, Harlem | 41 |
Time-driven Dosing, Harlem | 41 |
Event-driven Dosing, Harlem | 42 |
Time-driven Dosing, Cape Town | 8 |
Event-driven Dosing, Cape Town | 8 |
Daily Dosing, Bangkok | 8 |
Daily Dosing, Harlem | 8 |
Time-driven Dosing, Harlem | 5 |
Event-driven Dosing, Harlem | 5 |
Event-driven Dosing, Cape Town | 4 |
Daily Dosing, Bangkok | 2 |
Time-driven Dosing, Cape Town | 48 |
Event-driven Dosing, Cape Town | 48 |
Daily Dosing, Bangkok | 50 |
Time-driven Dosing, Bangkok | 44 |
Event-driven Dosing, Bangkok | 46 |
Daily Dosing, Harlem | 51 |
Time-driven Dosing, Harlem | 55 |
Event-driven Dosing, Harlem | 55 |
Time-driven Dosing, Cape Town | 59 |
Event-driven Dosing, Cape Town | 60 |
Daily Dosing, Harlem | 59 |
Time-driven Dosing, Cape Town | 3 |
Event-driven Dosing, Cape Town | 1 |
Daily Dosing, Harlem | 2 |
Time-driven Dosing, Cape Town | 1 |
Daily Dosing, Bangkok | 0 |
Time-driven Dosing, Cape Town | 0 |
Event-driven Dosing, Cape Town | 0 |
Daily Dosing, Harlem | 0 |
Event-driven Dosing, Harlem | 0 |
Daily Dosing, Cape Town | 56 |
Time-driven Dosing, Cape Town | 55 |
Event-driven Dosing, Cape Town | 59 |
Daily Dosing, Bangkok | 60 |
Daily Dosing, Harlem | 57 |
Event-driven Dosing, Harlem | 60 |
[back to top]
Self-reported Side Effect or Symptom Scores
The self-reported symptom/side effect scores for common symptoms/side effects including headache, dizziness, cramping, abdominal pain, and flatulence. Collected during clinic visits. All the presented numbers are the percent of visits with each side effects (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | percent of visits between week 6 to 30 (Number) |
---|
| Neurologic side effect | Gastrointestinal side effects |
---|
Daily Dosing, Bangkok | 14.2 | 13.1 |
,Daily Dosing, Cape Town | 12.4 | 10.6 |
,Daily Dosing, Harlem | 6.1 | 8 |
,Event-driven Dosing, Bangkok | 13.3 | 10.5 |
,Event-driven Dosing, Cape Town | 7.8 | 5.4 |
,Event-driven Dosing, Harlem | 4.5 | 7.1 |
,Time-driven Dosing, Bangkok | 14.3 | 8.5 |
,Time-driven Dosing, Cape Town | 6.0 | 8.8 |
,Time-driven Dosing, Harlem | 3.3 | 5.8 |
[back to top]
Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing
"Coverage will be determined based on the adjusted electronic and self-reported pill-use data. Specifically, a sex act will be considered as covered if at least one pill is taken 96 hours prior the sexual activity and at least one additional pill is taken within 24 hours after the sexual activity. If participant only took pill before the sexual activity (within 96 hours), but no pill taken after sexual activity (within 24 hours), then we considered it as pre-exposure covered. likewise, if participant only took pill after sexual activity (within 24 hours), but did not taken pill before sexual activity (within 96 hours), then we considered it as post-exposure covered. If participant did not taken pill before and after sexual activity, then it was considered as not covered. Note that the same pill can be both pre-exposure dose and a post-exposure dose if events are closely spaced. At no time should a participant in the intermittent arm be taking more pills than the daily arm." (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | percentage of sexual exposures (Number) |
---|
| % completely covered | % pre-exposure coverage | % post-exposure coverage | % uncovered |
---|
Daily Dosing, Bangkok | 85 | 11 | 1 | 3 |
,Daily Dosing, Cape Town | 75 | 21 | 1 | 3 |
,Daily Dosing, Harlem | 66 | 24 | 2 | 8 |
,Event-driven Dosing, Bangkok | 74 | 19 | 5 | 3 |
,Event-driven Dosing, Cape Town | 52 | 33 | 8 | 7 |
,Event-driven Dosing, Harlem | 52 | 29 | 6 | 13 |
,Time-driven Dosing, Bangkok | 84 | 12 | 3 | 1 |
,Time-driven Dosing, Cape Town | 56 | 30 | 9 | 5 |
,Time-driven Dosing, Harlem | 47 | 30 | 8 | 15 |
[back to top]
Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)
Below we presented the percentages of total cohort with TFV-DP concentrations consistent with >=2 pills/week in women who also report sex in the last 7 day for each arm. For Cape Town and Bangkok, TFV-DP in PBMC was analyzed, for Harlem site, the TFV-DP in DBS (dried blood spot) was analyzed. Note: PBMC >5.2 fmol/10^6 cells is considered as participants taken >=2 tablets per week; DBS >=326 fmol/punch is considered as participants taken >=2 tablets per week (NCT01327651)
Timeframe: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization
Intervention | Participants (Count of Participants) |
---|
| Week 10 | Week 18 | Week 30 |
---|
Daily Dosing, Bangkok | 31 | 28 | 22 |
,Daily Dosing, Cape Town | 33 | 29 | 19 |
,Daily Dosing, Harlem | 13 | 11 | 9 |
,Event-driven Dosing, Bangkok | 30 | 24 | 13 |
,Event-driven Dosing, Cape Town | 25 | 10 | 12 |
,Event-driven Dosing, Harlem | 5 | 3 | 3 |
,Time-driven Dosing, Bangkok | 29 | 30 | 18 |
,Time-driven Dosing, Cape Town | 16 | 16 | 13 |
,Time-driven Dosing, Harlem | 8 | 10 | 3 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Bangkok, Thailand, Seroconverted Participant #1 | 40 | 749590 | 92960 | 1799950 | 119720 | 127330 | 178070 | 96180 | 36140 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 5 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #2 | 400 | 3667690 | 3938670 | 93040 | 93660 | 114520 | 178210 | 89970 | 35210 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 6 | Week 10 | Week 14 | Week 18 | Week 22 |
---|
Cape Town, South Africa, Seroconverted Participant #4 | 400 | 400 | 400 | 650 | 400 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Day 3 | Week 4 | Week 5 | Week 10 |
---|
Cape Town, South Africa, Seroconverted Participant #1 | 20 | 400 | 3460 | 5732050 | 416070 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #7 | 83010 | 136310 | 25020 | 29390 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 5 | Week 6 |
---|
Bangkok, Thailand, Seroconverted Participant #2 | 78450 | 710 | 1570 | 5070 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Day 3 | Week 4 | Week 6 |
---|
Harlem, United States, Seroconverted Participant #1 | 400 | 40900 | 83260 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #3 | 503950 | 10910 |
,Cape Town, South Africa, Seroconverted Participant #8 | 400 | 400 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 14 | Week 18 |
---|
Harlem, United States, Seroconverted Participant #2 | 1567040 | 73030 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm. (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Week 22 |
---|
Cape Town, South Africa, Seroconverted Participant #5 | 5887760 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 |
---|
Cape Town, South Africa, Seroconverted Participant #3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 |
---|
Cape Town, South Africa, Seroconverted Participant #4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cape Town, South Africa, Seroconverted Participant #5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cape Town, South Africa, Seroconverted Participant #7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 |
---|
Harlem, United States, Seroconverted Participant #2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Cape Town, South Africa, Seroconverted Participant #6 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 |
---|
Cape Town, South Africa, Seroconverted Participant #2 | 0 | 0 | 0 | 0 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 6 |
---|
Bangkok, Thailand, Seroconverted Participant #1 | 0 | 0 | 0 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 |
---|
Bangkok, Thailand, Seroconverted Participant #2 | 0 | 0 | 0 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 |
---|
Cape Town, South Africa, Seroconverted Participant #1 | 0 | 1 |
,Harlem, United States, Seroconverted Participant #1 | 0 | 1 |
[back to top]
A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study
Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels (NCT01327651)
Timeframe: From Enrollment to week 30 (end of self-administered dosing)
Intervention | viral load (Number) |
---|
| Enrollment | Week 4 | Week 5 | Week 6 | Week 10 | Week 14 | Week 18 | Week 22 | Week 26 | Week 30 |
---|
Cape Town, South Africa, Seroconverted Participant #8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
[back to top]
A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm
Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm. (NCT01327651)
Timeframe: From week 6 (randomization week) to week 30 (end of self-administered dosing)
Intervention | Participants (Count of Participants) |
---|
| Blood and lymphatic system disorders | Cardiac disorders | Ear and labyrinth disorders | Eye disorders | Gastrointestinal disorders | General disorders and administration site conditio | Hepatobiliary disorders | Immune system disorders | Infections and infestations | Injury, poisoning and procedural complications | Investigations | Metabolism and nutrition disorders | Musculoskeletal and connective tissue disorders | Neoplasms benign, malignant, and unspecified | Nervous system disorders | Pregnancy, puerperium and perinatal conditions | Psychiatric disorders | Renal and urinary disorders | Reproductive system and breast disorders | Respiratory, thoracic and mediastinal disorders | Skin and subcutaneous tissue disorders | Social circumstances | Vascular disorders |
---|
Daily Dosing, Bangkok | 0 | 1 | 0 | 1 | 9 | 1 | 0 | 0 | 0 | 10 | 23 | 0 | 2 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 |
,Daily Dosing, Cape Town | 0 | 0 | 0 | 0 | 18 | 4 | 0 | 0 | 1 | 3 | 10 | 2 | 1 | 0 | 17 | 0 | 3 | 10 | 1 | 2 | 4 | 0 | 0 |
,Daily Dosing, Harlem | 0 | 0 | 0 | 0 | 13 | 3 | 0 | 0 | 0 | 13 | 9 | 4 | 0 | 0 | 7 | 0 | 2 | 8 | 0 | 2 | 1 | 0 | 1 |
,Event-driven Dosing, Bangkok | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 1 | 10 | 10 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 |
,Event-driven Dosing, Cape Town | 0 | 0 | 0 | 0 | 24 | 6 | 0 | 1 | 2 | 7 | 12 | 6 | 0 | 0 | 21 | 0 | 1 | 10 | 1 | 2 | 3 | 0 | 0 |
,Event-driven Dosing, Harlem | 1 | 0 | 0 | 0 | 16 | 4 | 0 | 0 | 0 | 10 | 7 | 5 | 3 | 0 | 5 | 0 | 3 | 4 | 0 | 0 | 0 | 0 | 0 |
,Time-driven Dosing, Bangkok | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 7 | 12 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
,Time-driven Dosing, Cape Town | 2 | 0 | 0 | 0 | 17 | 1 | 0 | 0 | 0 | 4 | 13 | 5 | 0 | 0 | 17 | 0 | 1 | 5 | 0 | 1 | 5 | 0 | 0 |
,Time-driven Dosing, Harlem | 2 | 0 | 0 | 0 | 13 | 9 | 0 | 0 | 0 | 16 | 9 | 5 | 0 | 0 | 4 | 0 | 2 | 9 | 0 | 0 | 2 | 0 | 0 |
[back to top]
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24
HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus. (NCT01332227)
Timeframe: From Day 1 to Week 24
Intervention | Percentage of participants (Number) |
---|
Atazanavir/Ritonavir + Raltegravir | 80.6 |
Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 94.6 |
[back to top]
[back to top]
Number of Participants With Virologic Rebound at Weeks 24 and 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. (NCT01332227)
Timeframe: Day 1 to Weeks 28 and 48
Intervention | Participants (Number) |
---|
| Week 24: Virologic rebound | Week 48: Virologic rebound |
---|
Atazanavir/Ritonavir + Raltegravir | 7 | 9 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 1 | 1 |
[back to top]
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 48
Intervention | Participants (Number) |
---|
| Genotypable (GI)/phenotypable isolates (PI) | Emergent genotypic substitutions in GI pts (n=5,0) | Phenotypic resistance in PI pts (n=5,0) |
---|
Atazanavir/Ritonavir + Raltegravir | 5 | 5 | 1 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 0 | 0 | 0 |
[back to top]
Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24
Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients (NCT01332227)
Timeframe: Day 1 to Week 24
Intervention | Participants (Number) |
---|
| Genotypable (GI)/phenotypable isolates (PI) | Emergent genotypic substitutions in GI pts (n=4,0) | Phenotypic resistance in PI pts (n=4,0) |
---|
Atazanavir/Ritonavir + Raltegravir | 4 | 4 | 1 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 0 | 0 | 0 |
[back to top]
Mean Changes in Fasting Lipid Levels From Baseline to Week 48
LD=low-density lipoprotein; HDL=high-density lipoprotein. (NCT01332227)
Timeframe: From Baseline to Week 48
Intervention | mg/dL (Mean) |
---|
| Fasting total cholesterol | Fasting LDL cholesterol | Fasting HDL cholesterol | Fasting non-HDL cholesterol | Fasting triglycerides |
---|
Atazanavir/Ritonavir + Raltegravir | 11.7 | 7.7 | 2.7 | 9.0 | 14.7 |
,Atazanavir/Ritonavir + Tenofovir/Emtricitabine | -10.2 | -5.4 | -0.3 | -9.8 | -17.6 |
[back to top]
Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48
Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals. (NCT01332227)
Timeframe: From Day 1 to Week 48
Intervention | Percentage of participants (Number) |
---|
Atazanavir/Ritonavir + Raltegravir | 69.4 |
Atazanavir/Ritonavir + Tenofovir/Emtricitabine | 86.5 |
[back to top]
Drug Levels in Blood
rategravir concentration (NCT01335620)
Timeframe: Day 28
Intervention | ng/ml (Geometric Mean) |
---|
Truvada Plus Raltegravir | 1732 |
[back to top]
Cerebral Function; Changes in Global Cognitive Z-score
"Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.~Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion." (NCT01335620)
Timeframe: 6 months
Intervention | score on a scale (Mean) |
---|
Truvada Plus Raltegravir | 0.91 |
[back to top]
Number of Participants Non-adherent as Measured by 3-day Recall
Number of participants reporting a missed medication dose in the past 3 days. (NCT01338025)
Timeframe: 28 Weeks
Intervention | participants (Number) |
---|
Arm A, Non-suppressive HAART Regimen | 3 |
Arm B, 3TC or FTC Monotherapy | 1 |
[back to top]
Number of Participants With Immunologic Deterioration
"Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:~greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or~development of CDC class C events.~Results report number of participants with immunologic deterioration at week 28 calculated." (NCT01338025)
Timeframe: From entry to week 28
Intervention | participants (Number) |
---|
Arm A, Non-suppressive HAART Regimen | 0 |
Arm B, 3TC or FTC Monotherapy | 5 |
[back to top]
Change in CD4+ T Cell Count
Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28). (NCT01338025)
Timeframe: Entry to week 28
Intervention | CD4+ T cell count/mL (Median) |
---|
Arm A, Non-suppressive HAART Regimen | 27.5 |
Arm B, 3TC or FTC Monotherapy | 76 |
[back to top]
Change in HIV-1 RNA Levels
Change in HIV-1 RNA levels from Entry to Week 28 (NCT01338025)
Timeframe: 28 Weeks
Intervention | copies/mL (Median) |
---|
Arm A, Non-suppressive HAART Regimen | 3087 |
Arm B, 3TC or FTC Monotherapy | -2241 |
[back to top]
Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).
Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012). (NCT01345630)
Timeframe: Week 48
Intervention | Number of participants (Number) |
---|
| Confirmed PDTF | Evaluable PDTF |
---|
FTC/TDF+DRV/r | 13 | 3 |
,MVC+DRV/r | 40 | 17 |
[back to top]
Tropism Change Between Screening or Baseline and PDTF
For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF. (NCT01345630)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| R5 (Randomized Assay) | NON R5 (Randomized Assay) | NR (Randomized Assay) | R5 (Alternate Assay) | NON R5 (Alternate Assay) | NR (Alternate Assay) |
---|
FTC/TDF+DRV/r - Baseline | 2 | 0 | 1 | 3 | 0 | 0 |
,FTC/TDF+DRV/r - Failure | 1 | 0 | 2 | 2 | 1 | 0 |
,MVC+DRV/r - Baseline | 14 | 1 | 2 | 10 | 2 | 5 |
,MVC+DRV/r - Failure | 13 | 1 | 3 | 10 | 3 | 4 |
[back to top]
Severity of Abnormal Laboratory Values
Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant. (NCT01345630)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Alanine Aminotransferase (ALT) (n=396, 400) | Alkaline Phosphatase (n=396, 400) | Amylase (n=396, 400) | Aspartate Aminotransferase (AST) (n=396, 400) | Blood Urea Nitrogen (BUN) (n=396, 400) | Calcium (n=396, 400) | Creatine Kinase (n=396, 400) | Hemoglobin (n=396, 400) | LDL Cholesterol (n=396, 400) | Lipase (n=116, 122) | Lymphocytes (Abs) (n=396, 400) | Phosphate (n=396, 400) | Platelets (n=396, 400) | Potassium (n=396, 400) | Sodium (n=396, 400) | Total Bilirubin (n=396, 400) | Total Neutrophils (Abs) (n=396, 400) | Triglycerides (n=396, 400) | Uric Acid (n=396, 400) | White Blood Cell Count (n=396, 400) | Creatinine (n=396, 400) |
---|
FTC/TDF+DRV/r | 6 | 0 | 13 | 7 | 5 | 10 | 22 | 2 | 24 | 10 | 2 | 12 | 1 | 2 | 0 | 1 | 2 | 6 | 2 | 0 | 1 |
,MVC+DRV/r | 9 | 1 | 5 | 11 | 3 | 7 | 18 | 4 | 50 | 3 | 2 | 5 | 5 | 3 | 2 | 3 | 6 | 4 | 0 | 1 | 0 |
[back to top]
Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)
The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
Intervention | Percentage of lymphocytes (Mean) |
---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) |
---|
FTC/TDF+DRV/r | 55.8 | 43.0 | -12.6 |
,MVC+DRV/r | 57.0 | 46.0 | -10.9 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.
"The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure." (NCT01345630)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
MVC+DRV/r | 77.3 |
FTC/TDF+DRV/r | 86.8 |
[back to top]
Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)
The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
Intervention | Percentage of lymphocytes (Mean) |
---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) |
---|
FTC/TDF+DRV/r | 24.5 | 33.7 | 9.2 |
,MVC+DRV/r | 24.2 | 31.3 | 7.0 |
[back to top]
[back to top]
Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48
A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. (NCT01345630)
Timeframe: Week 48
Intervention | ratio (Least Squares Mean) |
---|
MVC+DRV/r | 0.017 |
FTC/TDF+DRV/r | -0.014 |
[back to top]
Frequency of Adverse Events (AE).
Number of participants with treatment-emergent non serious AEs (NCT01345630)
Timeframe: Week 96
Intervention | participants (Number) |
---|
MVC+DRV/r | 360 |
FTC/TDF+DRV/r | 365 |
[back to top]
Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.
For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism. (NCT01345630)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| Not eligible for analysis (failed tropism test) | Not eligible for analysis (non-R5 tropism) | Eligible for analysis (R5 virus using ESTA) | Results reported | Maximal percent inhibition <95% | IC50 FC ≥3.0 |
---|
FTC/TDF+DRV/r | 1 | 1 | 1 | 1 | 0 | 0 |
,MVC+DRV/r | 4 | 1 | 12 | 12 | 0 | 0 |
[back to top]
Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria
For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI's were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm. (NCT01345630)
Timeframe: Week 48
Intervention | participants (Number) |
---|
| NRTI - All (Baseline, n=15, 3) | NNRTI Delavirdine (Baseline, n=15, 3) | NNRTI Nevirapine (Baseline, n=15, 3) | NNRTI Efavirenz (Baseline, n=15, 3) | PRI - All (Baseline, n=15, 3) | NRTI - All (PDTF, n=15, 3) | NNRTI Delavirdine (PDTF, n=15, 3) | NNRTI Nevirapine (PDTF, n=15, 3) | NNRTI Efavirenz (PDTF, n=15, 3) | PRI - All (PDTF, n=15, 3) |
---|
FTC/TDF+DRV/r | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,MVC+DRV/r | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 |
[back to top]
Number of Participants With Abnormal Laboratory Values
Number of participants with laboratory abnormalities are reported (NCT01345630)
Timeframe: Week 96
Intervention | participants (Number) |
---|
| Normal Baseline | Abnormal Baseline |
---|
FTC/TDF+DRV/r | 205 | 101 |
,MVC+DRV/r | 210 | 111 |
[back to top]
Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48
The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
Intervention | Ratio (Mean) |
---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) |
---|
FTC/TDF+DRV/r | 0.48 | 0.87 | 0.39 |
,MVC+DRV/r | 0.47 | 0.75 | 0.28 |
[back to top]
Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)
The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
Intervention | cell/mm^3 (Mean) |
---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) |
---|
FTC/TDF+DRV/r | 914.5 | 751.1 | -157.9 |
,MVC+DRV/r | 954.4 | 900.0 | -49.9 |
[back to top]
Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)
The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared. (NCT01345630)
Timeframe: Baseline, Week 48
Intervention | cell/mm^3 (Mean) |
---|
| Baseline (n=396, 401) | Week 48 (n=394, 396) | Change from Baseline at Week 48 (n=394, 396) |
---|
FTC/TDF+DRV/r | 379.5 | 574.6 | 194.2 |
,MVC+DRV/r | 382.0 | 576.9 | 194.9 |
[back to top]
Number of Participants With Treatment-emergent Serious Adverse Events
Total number of participants with treatment-emergent serious adverse events are reported (NCT01345630)
Timeframe: Week 96
Intervention | participants (Number) |
---|
MVC+DRV/r | 41 |
FTC/TDF+DRV/r | 40 |
[back to top]
Number of Participants With Grade 3 or 4 AEs
Number of participants with grade 3 or 4 AEs are presented here. (NCT01345630)
Timeframe: Week 96
Intervention | participants (Number) |
---|
MVC+DRV/r | 65 |
FTC/TDF+DRV/r | 71 |
[back to top]
Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.
A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline. (NCT01345630)
Timeframe: Week 48
Intervention | gram (Least Squares Mean) |
---|
MVC+DRV/r | -181.6 |
FTC/TDF+DRV/r | -257.5 |
[back to top]
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD
Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48
Intervention | g/cm^2 (Least Squares Mean) |
---|
MVC+DRV/r | -0.014 |
FTC/TDF+DRV/r | -0.028 |
[back to top]
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD
Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48
Intervention | g/cm^2 (Least Squares Mean) |
---|
MVC+DRV/r | -0.021 |
FTC/TDF+DRV/r | -0.029 |
[back to top]
Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD
Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan. (NCT01345630)
Timeframe: Week 48
Intervention | g/cm^2 (Least Squares Mean) |
---|
MVC+DRV/r | -0.020 |
FTC/TDF+DRV/r | -0.025 |
[back to top]
Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)
Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study. (NCT01345630)
Timeframe: Week 48
Intervention | pg/mL (Mean) |
---|
MVC+DRV/r | 121.13 |
FTC/TDF+DRV/r | 223.52 |
[back to top]
Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin
Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study. (NCT01345630)
Timeframe: Week 48
Intervention | ng/mL (Mean) |
---|
MVC+DRV/r | 5.61 |
FTC/TDF+DRV/r | 6.77 |
[back to top]
The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).
The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA's Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method. (NCT01345630)
Timeframe: Week 48
Intervention | proportion of participants (Number) |
---|
MVC+DRV/r | 0.8047 |
FTC/TDF+DRV/r | 0.8797 |
[back to top]
Number of Participants Who Discontinued Due to AEs
Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants. (NCT01345630)
Timeframe: Week 96
Intervention | participants (Number) |
---|
MVC+DRV/r | 22 |
FTC/TDF+DRV/r | 23 |
[back to top]
Cumulative Incidence of Initial KS Partial or Complete Response by Week 96
KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From entry through 96 weeks
Intervention | cumulative events per 100 participants (Number) |
---|
Arm A: ART Alone Period (Step 1) | 39.89 |
Arm B: ART With Immediate ET | 64.08 |
[back to top]
Percentage of Participants With ARV Dose Modification
ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category. (NCT01352117)
Timeframe: From treatment dispensation to Week 96
Intervention | percentage of participants (Number) |
---|
| Temporarily held | Prematurely discontinued | Increased |
---|
Arm A: ART Alone or With Delayed ET | 7.4 | 26.6 | 1.1 |
,Arm B: ART With Immediate ET | 11.5 | 21.9 | 0 |
[back to top]
Percentage of Participants With HIV-1 RNA Suppression
HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
Intervention | percentage of participants (Number) |
---|
| Entry: HIV-1 RNA suppression | Week 12: HIV-1 RNA suppression | Week 24: HIV-1 RNA suppression | Week 32: HIV-1 RNA suppression | Week 48: HIV-1 RNA suppression | Week 72: HIV-1 RNA suppression | Week 96: HIV-1 RNA suppression |
---|
Arm B: ART With Immediate ET | 4.2 | 90.6 | 97.5 | 94.7 | 98.6 | 96.6 | 93.8 |
[back to top]
Percentage of Participants With Etoposide Dose Modification
Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category. (NCT01352117)
Timeframe: From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)
Intervention | percentage of participants (Number) |
---|
| Temporarily held | Resumed at a different dose | Deferred | Discontinued | Underdosed |
---|
Arm A: ART With Delayed ET (Step 2) | 0 | 15.6 | 37.5 | 6.3 | 0 |
,Arm B: ART With Immediate ET | 5.2 | 9.4 | 24.0 | 10.4 | 1.0 |
[back to top]
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
Intervention | cells/mm^3 (Median) |
---|
| Week 12: CD4 change | Week 24: CD4 change | Week 32: CD4 change | Week 48: CD4 change | Week 72: CD4 change | Week 96: CD4 change |
---|
Arm B: ART With Immediate ET | 67 | 121 | 119 | 121 | 125 | 206 |
[back to top]
Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
Intervention | cells/mm^3 (Median) |
---|
| Week 12: CD4 change | Week 24: CD4 change | Week 32: CD4 change | Week 48: CD4 change | Week 72: CD4 change | Week 96: CD4 change | Step 2 Week 12: CD4 change | Step 2 Week 24: CD4 change | Step 2 Week 32: CD4 change | Step 2 Week 48: CD4 change | Step 2 Week 72: CD4 change |
---|
Arm A: ART Alone or With Delayed ET | 40 | 57 | 90 | 125 | 143 | 149 | -13 | -15 | 28 | 2 | 51 |
[back to top]
Number of Participants With Grade 3 or Higher Adverse Events
Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. (NCT01352117)
Timeframe: From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.
Intervention | Participants (Count of Participants) |
---|
Arm A: ART Alone or With Delayed ET | 47 |
Arm B: ART With Immediate ET | 42 |
[back to top]
Cumulative Incidence of KS-IRIS
KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease. (NCT01352117)
Timeframe: From study entry to Week 12
Intervention | cumulative events per 100 participants (Number) |
---|
Arm A: ART Alone or With Delayed ET | 23.14 |
Arm B: ART With Immediate ET | 7.40 |
[back to top]
Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A
KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)
Intervention | cumulative events per 100 participants (Number) |
---|
Arm A: ART With Delayed ET Period (Step 2) | 62.57 |
[back to top]
Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A
KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)
Intervention | cumulative events per 100 participants (Number) |
---|
Arm A: ART With Delayed ET Period (Step 2) | 35.78 |
[back to top]
Percentage of Participants With HIV-1 RNA Suppression
HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET. (NCT01352117)
Timeframe: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
Intervention | percentage of participants (Number) |
---|
| Entry: HIV-1 RNA suppression | Week 12: HIV-1 RNA suppression | Week 24: HIV-1 RNA suppression | Week 32: HIV-1 RNA suppression | Week 48: HIV-1 RNA suppression | Week 72: HIV-1 RNA suppression | Week 96: HIV-1 RNA suppression | Step 2 entry: HIV-1 RNA suppression | Step 2 Week 12: HIV-1 RNA suppression | Step 2 Week 24: HIV-1 RNA suppression | Step 2 Week 32: HIV-1 RNA suppression | Step 2 Week 48: HIV-1 RNA suppression | Step 2 Week 72: HIV-1 RNA suppression |
---|
Arm A: ART Alone or With Delayed ET | 4.3 | 90.3 | 94.5 | 92.0 | 95.3 | 91.2 | 92.9 | 93.3 | 100.0 | 95.8 | 96.0 | 100.0 | 100.0 |
[back to top]
Cumulative Incidence of Initial KS Progressive Disease by Week 96
KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. (NCT01352117)
Timeframe: From entry through 96 weeks
Intervention | cumulative events per 100 participants (Number) |
---|
Arm A: ART Alone Period (Step 1) | 60.61 |
Arm B: ART With Immediate ET | 52.73 |
[back to top]
Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure
Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline. (NCT01352715)
Timeframe: From study entry through to week 96
Intervention | participants (Number) |
---|
| No new IAS mutations | 1-2 new IAS mutations | 3 new IAS mutations |
---|
Arm A: LPV/r Plus RAL | 29 | 9 | 1 |
,Arm B: LPV/r Plus Best Available NRTIs | 32 | 13 | 0 |
[back to top]
Percentage of Time Spent in Hospital
The percentage of total study time that participants were in hospital. (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)
Intervention | percentage of time spent in hospital (Number) |
---|
Arm A: LPV/r Plus RAL | 0.08 |
Arm B: LPV/r Plus Best Available NRTIs | 0.12 |
[back to top]
Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline
The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs. (NCT01352715)
Timeframe: From start of randomized treatment to off randomized treatment (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 62 |
Arm B: LPV/r Plus Best Available NRTIs | 81 |
[back to top]
Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death
Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 7 |
Arm B: LPV/r Plus Best Available NRTIs | 7 |
[back to top]
Number of Participants With a New AIDS-defining Events or Death
AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO) (NCT01352715)
Timeframe: From study entry throughout follow-up (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 15 |
Arm B: LPV/r Plus Best Available NRTIs | 17 |
[back to top]
Number of Participants Discontinuing Randomized Treatment for Toxicity
Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations. (NCT01352715)
Timeframe: From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)
Intervention | participants (Number) |
---|
Arm A: LPV/r Plus RAL | 3 |
Arm B: LPV/r Plus Best Available NRTIs | 3 |
[back to top]
Cumulative Probability of Virologic Failure by Week 48
The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used. (NCT01352715)
Timeframe: From study entry to week 48
Intervention | cumulative probability per 100 persons (Number) |
---|
Arm A: LPV/r Plus RAL | 10.3 |
Arm B: LPV/r Plus Best Available NRTIs | 12.4 |
[back to top]
Change in CD4+ Cell Count From Baseline to Week 48
Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry. (NCT01352715)
Timeframe: Study entry and week 48
Intervention | cells/mm^3 (Mean) |
---|
Arm A: LPV/r Plus RAL | 199 |
Arm B: LPV/r Plus Best Available NRTIs | 190 |
[back to top]
Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline
Fasting was for 8 hours and the metabolic panel was drawn locally. (NCT01352715)
Timeframe: Study entry and week 48
Intervention | mg/dL (Mean) |
---|
| total cholesterol change | high-density lipoprotein (HDL) cholesterol change | low-density lipoprotein (LDL) cholesterol change | triglycerides change | glucose change |
---|
Arm A: LPV/r Plus RAL | 31 | 4 | 17 | 80 | 2 |
,Arm B: LPV/r Plus Best Available NRTIs | 15 | 2 | 10 | 31 | 3 |
[back to top]
Number of Participants Who Died During the Study
Number of participants who died during the study (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | participants (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 0 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 0 |
[back to top]
Number of Participants Who Experienced Bone Fractures
Number of participants who experienced bone fractures during the study (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | participants (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 2 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 2 |
[back to top]
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)
The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48. (NCT01400412)
Timeframe: Week 0, week 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -1.51 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -2.40 |
[back to top]
Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 11.9 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 14.0 |
[back to top]
Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -9.1 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -11.2 |
[back to top]
Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -3.5 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -4.6 |
[back to top]
Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48
percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -20.7 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -17.0 |
[back to top]
Percent Change in Lumbar Spine Bone Mineral Density (BMD)
The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48. (NCT01400412)
Timeframe: Week 0, week 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -0.88 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -2.35 |
[back to top]
Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48
percentage change is define as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -52.1 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -48.6 |
[back to top]
Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48
percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100% (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | percentage change (Median) |
---|
MVC Arm: DRV/r + MVC + FTC + TDF Placebo | -59.5 |
TDF Arm: DRV/r + TDF + FTC + MVC Placebo | -60.9 |
[back to top]
CD8+ T-cell Change From Baseline to Week 48
CD8+ T-cell change from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | cell/mm^3 (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -6 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -109 |
[back to top]
Change in CD4 Count From Baseline to Week 24
Change in CD4 count from baseline (week 0) to week 24 (NCT01400412)
Timeframe: Week 0, week 24
Intervention | cells/mm^3 (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 165 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 127 |
[back to top]
Change in CD4 Count From Baseline to Week 48
Change in CD4 count from baseline (week 0) to week 48 (NCT01400412)
Timeframe: Week 0, week 48
Intervention | cells/mm^3 (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 234 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 188 |
[back to top]
Change in Level of IP-10 From Baseline to Week 48
Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | pg/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -198 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -170 |
[back to top]
Change in Levels of D-dimer From Baseline
Change in levels of D-dimer from baseline (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | ng/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -82 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -61 |
[back to top]
Change in Levels of IL-6 From Baseline to Week 48
Change in levels of Interleukin 6 (IL-6) from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | pg/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -0.21 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -0.12 |
[back to top]
Change in Levels of sCD14 From Baseline
Change in levels of soluble CD14 from baseline (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | ng/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -103 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -10 |
[back to top]
Cumulative Probability of Virologic Failure by Week 48
"Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.~Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group." (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | cumulative probability per 100 persons (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 6 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 5 |
[back to top]
Change in Levels of sCD163 From Baseline to Week 48
Change in levels of soluble CD163 from baseline to week 48 (NCT01400412)
Timeframe: At weeks 0 and 48
Intervention | ng/ml (Median) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | -250 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | -258 |
[back to top]
Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events
"Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.~See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)" (NCT01400412)
Timeframe: From study treatment initiation to week 48
Intervention | participants (Number) |
---|
MVC Arm (DRV/r + MVC + FTC + TDF Placebo) | 16 |
TDF Arm (DRV/r + TDF + FTC + MVC Placebo) | 22 |
[back to top]
Duration of Objective Response for ET+ART vs. PTX+ART
Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144
Intervention | weeks (Number) |
---|
ET+ART | 10.1 |
PTX+ART | 19.9 |
[back to top]
Duration of Objective Response for BV+ART vs. PTX+ART
Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented. (NCT01435018)
Timeframe: From study entry up to week 144
Intervention | weeks (Number) |
---|
ET+ART | 21.0 |
PTX+ART | 45.7 |
[back to top]
Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART
Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 19.7 |
PTX+ART | 49.8 |
[back to top]
Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART
Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 44.1 |
PTX+ART | 64.2 |
[back to top]
Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 72.4 |
PTX+ART | 54.6 |
[back to top]
Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48 (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 56.7 |
PTX+ART | 42.1 |
[back to top]
Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 57.6 |
PTX+ART | 33.9 |
[back to top]
Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 54.5 |
PTX+ART | 36.2 |
[back to top]
Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 77.5 |
PTX+ART | 54.6 |
[back to top]
Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48 (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 60.9 |
PTX+ART | 42.0 |
[back to top]
Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 69.8 |
PTX+ART | 41.2 |
[back to top]
Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 43.9 |
PTX+ART | 25.7 |
[back to top]
Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART
Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 7.8 |
PTX+ART | 0.0 |
[back to top]
Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART
Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 7.4 |
PTX+ART | 1.8 |
[back to top]
Cumulative Rate of Death for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 25.6 |
PTX+ART | 10.7 |
[back to top]
Cumulative Rate of Death for BV+ART vs PTX+ART
The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later. (NCT01435018)
Timeframe: From study entry to week 240
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 18.5 |
PTX+ART | 10.3 |
[back to top]
Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to date of death. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 25.6 |
PTX+ART | 10.7 |
[back to top]
Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to the death date. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 18.5 |
PTX+ART | 10.3 |
[back to top]
Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 59.5 |
PTX+ART | 26.0 |
[back to top]
Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 32.5 |
PTX+ART | 18.9 |
[back to top]
Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
ET+ART | 15.2 |
PTX+ART | 28.6 |
[back to top]
Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART
The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. (NCT01435018)
Timeframe: From study entry to week 48
Intervention | Cumulative events per 100 persons (Number) |
---|
BV+ART | 17.9 |
PTX+ART | 19.6 |
[back to top]
Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART
KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12
Intervention | Participants (Count of Participants) |
---|
BV+ART | 2 |
PTX+ART | 0 |
[back to top]
Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART
KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm^3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression. (NCT01435018)
Timeframe: From study entry to week 12
Intervention | Participants (Count of Participants) |
---|
ET+ART | 6 |
PTX+ART | 0 |
[back to top]
Number of Participants With Objective Response for BV+ART vs. PTX+ART
The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144
Intervention | Participants (Count of Participants) |
---|
BV+ART | 80 |
PTX+ART | 91 |
[back to top]
Number of Participants With Objective Response for ET+ART vs. PTX+ART
The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). (NCT01435018)
Timeframe: From study entry up to week 144
Intervention | Participants (Count of Participants) |
---|
ET+ART | 18 |
PTX+ART | 34 |
[back to top]
Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART
Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240
Intervention | weeks (Number) |
---|
BV+ART | 24.7 |
PTX+ART | 38.6 |
[back to top]
Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART
Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or the participant's off study week, whichever is later. The 25-th percentile and hazard ratio are presented. (NCT01435018)
Timeframe: From study entry to week 240
Intervention | weeks (Number) |
---|
ET+ART | 17.9 |
PTX+ART | 30.0 |
[back to top]
Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART
Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48
Intervention | cells/mm^3 (Median) |
---|
| Week 12 CD4 change | Week 24 CD4 change | Week 48 CD4 change |
---|
BV+ART | 21 | 43 | 112 |
,PTX+ART | 37 | 65 | 105 |
[back to top]
Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART
Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count. (NCT01435018)
Timeframe: Baseline, weeks 12, 24, 48
Intervention | cells/mm^3 (Median) |
---|
| Week 12 CD4 change | Week 24 CD4 change | Week 48 CD4 change |
---|
ET+ART | 37 | 106 | 69 |
,PTX+ART | 47 | 95 | 157 |
[back to top]
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 2
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 2 treatment arm. (NCT01435018)
Timeframe: From Step 2 study entry to Step 2 discontinuation, up to 144 weeks
Intervention | Participants (Count of Participants) |
---|
| With IERC-confirmed KS progression | With dose-limiting toxicity | Died | With AIDS-defining events | With virologic failure | With objective response |
---|
BV+ART | 1 | 0 | 1 | 1 | 2 | 7 |
,ET+ART | 1 | 0 | 0 | 0 | 1 | 0 |
,PTX+ART | 1 | 0 | 5 | 0 | 1 | 5 |
[back to top]
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 3
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 3 treatment arm. (NCT01435018)
Timeframe: From Step 3 study entry to Step 3 discontinuation, up to 144 weeks
Intervention | Participants (Count of Participants) |
---|
| With IERC-confirmed KS progression | With dose-limiting toxicity | Died | With AIDS-defining events | With virologic failure | With objective response |
---|
BV+ART | 6 | 0 | 3 | 5 | 2 | 18 |
,ET+ART | 2 | 0 | 0 | 0 | 2 | 5 |
,PTX+ART | 8 | 0 | 7 | 7 | 1 | 29 |
[back to top]
Number of Participants With IERC-Confirmed KS Disease Progression, Dose-Limiting Toxicity, Death, AIDS-Defining Events, Virologic Failure and Objective Response in Step 4
IERC-confirmed KS progression refers to KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Virologic failure is defined as two successive measurements of plasma HIV-1 RNA >=1000 copies/mL at week 12 to week 24 or RNA >=400 copies/mL at week 24 or later. Objective response refers to complete response or partial response as best overall KS response. Results are presented by Step 4 treatment arm. (NCT01435018)
Timeframe: From Step 4 study entry to Step 4 discontinuation, up to 96 weeks
Intervention | Participants (Count of Participants) |
---|
| With IERC-confirmed KS progression | With dose-limiting toxicity | Died | With AIDS-defining events | With virologic failure | With objective response |
---|
BV+ART | 2 | 0 | 3 | 0 | 1 | 3 |
,PTX+ART | 3 | 0 | 2 | 0 | 0 | 3 |
[back to top]
Number of Participants With Peripheral Neuropathy (PN)
Presence of PN is defined as having all of the following results: presence of symptomatic PN, abnormal perception of vibrations, and absent or hypoactive deep tendon reflexes. (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.
Intervention | Participants (Count of Participants) |
---|
| Screening | Week 3 | Week 6 | Week 9 | Week 12 | Week 15 | Week 18 | Week 21 |
---|
BV+ART | 7 | 1 | 1 | 3 | 3 | 2 | 6 | 5 |
,ET+ART | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,PTX+ART | 0 | 0 | 2 | 2 | 4 | 3 | 1 | 2 |
[back to top]
Number of Participants With Symptomatic Peripheral Neuropathy (SPN)
"SPN consists of three assessments: (1) pain, aching or burning in feet, legs, (2) pins and needles in feet, legs, and (3) numbness (lack of feeling) in feet, legs. SPN is graded on a severity scale from 0 (not present), 1 (mild) to 10 (severe). Presence of SPN is defined as having grade >=1 in at least one of the three assessments." (NCT01435018)
Timeframe: Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.
Intervention | Participants (Count of Participants) |
---|
| Screening | Week 3 | Week 6 | Week 9 | Week 12 | Week 15 | Week 18 | Week 21 |
---|
BV+ART | 76 | 62 | 46 | 40 | 36 | 26 | 25 | 30 |
,ET+ART | 24 | 0 | 0 | 14 | 0 | 0 | 0 | 4 |
,PTX+ART | 59 | 34 | 32 | 27 | 23 | 16 | 15 | 20 |
[back to top]
[back to top]
Self-reported Adherence to ART Therapy
ART adherence is based on participant's recall of the number of missed ART doses for the past month. Perfect adherence is defined as having zero missed ART doses. (NCT01435018)
Timeframe: At Weeks 6, 12, 18, 30 and 48
Intervention | Participants (Count of Participants) |
---|
| Week 6 Perfect Adherence | Week 12 Perfect Adherence | Week 18 Perfect adherence | Week 30 Perfect adherence | Week 48 Perfect adherence |
---|
BV+ART | 101 | 101 | 85 | 66 | 13 |
,ET+ART | 43 | 36 | 29 | 13 | 0 |
,PTX+ART | 106 | 103 | 97 | 85 | 20 |
[back to top]
Unprotected Sex Acts in Previous One Week - 52 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 52 weeks (NCT01450189)
Timeframe: 52 weeks
Intervention | unprotected sex acts/week (Mean) |
---|
Standard Counseling Arm | 0.8 |
Behavioral Intervention Arm Only | 0.2 |
Behavioral Intervention Plus ARV | 0 |
[back to top]
Number of Partners Reporting for HIV Testing
Number of partners per index reporting for HIV testing at any time during follow-up (NCT01450189)
Timeframe: 52 weeks
Intervention | partners per index participant (Mean) |
---|
Standard Counseling Arm | 0.4 |
Behavioral Intervention Arm Only | 0.4 |
Behavioral Intervention Plus ARV | 0.4 |
[back to top]
Proportion of Participants Completing Full Course of ARVs in Arm BIA
Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that (NCT01450189)
Timeframe: 1 year
Intervention | proportion of BIA participants (Number) |
---|
Behavioral Intervention Plus Antiretrovirals (BIA) | 0.917 |
[back to top]
Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms. (NCT01450189)
Timeframe: 1 year
Intervention | proportion of participants (Number) |
---|
Combined Behavioral Intervention Arms | 0.216 |
[back to top]
Proportion of Partners Reporting for HIV Testing
Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants (NCT01450189)
Timeframe: 52 weeks
Intervention | proportion of sex partners (Number) |
---|
Standard Counseling Arm | 0.1 |
Behavioral Intervention Arm Only | 0.1 |
Behavioral Intervention Plus ARV | 0.1 |
[back to top]
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
(NCT01450189)
Timeframe: 1 year
Intervention | proportion of participants screened (Number) |
---|
Overall | 0.622 |
[back to top]
Proportion of Persons Completing All Scheduled Visits in Each Study Arm
(NCT01450189)
Timeframe: 1 year
Intervention | Proportion of participants (Number) |
---|
Standard Counseling Arm | 0.44 |
Behavioral Intervention Arm | 0.44 |
Behavioral Intervention Plus Antiretrovirals (BIA) | 0.37 |
[back to top]
Proportion of Persons With AHI Successfully Recruited Into the Study
This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization. (NCT01450189)
Timeframe: 1 year
Intervention | Proportion of persons with AHI recruited (Number) |
---|
Overall | 0.69 |
[back to top]
Suppression of HIV RNA to <1000c/ml at 12 Weeks
Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks (NCT01450189)
Timeframe: 12 weeks
Intervention | Proportion of participants (Number) |
---|
Standard Counseling Arm | 0.5 |
Behavioral Intervention Arm Only | 0.25 |
Behavioral Intervention Plus ARV | 0.72 |
[back to top]
Prevalence of AHI Among Persons Screened
Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization. (NCT01450189)
Timeframe: 1 year
Intervention | proportion of participants (Number) |
---|
Overall | 0.0073 |
[back to top]
Time to HIV RNA Suppression <1000 c/ml
median time to viral load suppression (<1000 c/ml) (NCT01450189)
Timeframe: From date of randomization until viral load suppression, up to 52 weeks
Intervention | weeks (Median) |
---|
Standard Counseling Arm | 39 |
Behavioral Intervention Arm Only | 26 |
Behavioral Intervention Plus ARV | 16 |
[back to top]
Unprotected Sex Acts in Previous One Month - 12 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 12 weeks (NCT01450189)
Timeframe: 12 weeks
Intervention | unprotected sex acts/month (Mean) |
---|
Standard Counseling Arm | 0 |
Behavioral Intervention Arm Only | 0.8 |
Behavioral Intervention Plus ARV | 0 |
[back to top]
Unprotected Sex Acts in Previous One Month - 26 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 26 weeks (NCT01450189)
Timeframe: 26 weeks
Intervention | unprotected sex acts/month (Mean) |
---|
Standard Counseling Arm | 0.25 |
Behavioral Intervention Arm Only | 0.2 |
Behavioral Intervention Plus ARV | 0.4 |
[back to top]
Blood HIV RNA Concentration at Week 52
(NCT01450189)
Timeframe: 52 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 3248.5 |
Behavioral Intervention Arm Only | 6467.5 |
Behavioral Intervention Plus ARV | 10876 |
[back to top]
Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 52 weeks
Intervention | Proportion of participants (Number) |
---|
Standard Counseling Arm | 0.5 |
Behavioral Intervention Arm Only | 1.0 |
Behavioral Intervention Plus ARV | 0.3 |
[back to top]
Unprotected Sex Acts in Previous One Week - 26 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 26 weeks (NCT01450189)
Timeframe: 26 weeks
Intervention | unprotected sex acts/week (Mean) |
---|
Standard Counseling Arm | 0.25 |
Behavioral Intervention Arm Only | 0.1 |
Behavioral Intervention Plus ARV | 0.5 |
[back to top]
Genital HIV RNA Concentration - Week 12, Men
median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 12 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 25364 |
Behavioral Intervention Arm Only | 446 |
Behavioral Intervention Plus ARV | 0 |
[back to top]
Unprotected Sex Acts in Previous One Week - 12 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 12 weeks (NCT01450189)
Timeframe: 12 weeks
Intervention | unprotected sex acts/week (Mean) |
---|
Standard Counseling Arm | 0 |
Behavioral Intervention Arm Only | 0.5 |
Behavioral Intervention Plus ARV | 1.2 |
[back to top]
Unprotected Sex Acts in Previous One Month - 52 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 52 weeks (NCT01450189)
Timeframe: 52 weeks
Intervention | unprotected sex acts/month (Mean) |
---|
Standard Counseling Arm | 0.8 |
Behavioral Intervention Arm Only | 0.5 |
Behavioral Intervention Plus ARV | 0 |
[back to top]
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
At least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 52 weeks
Intervention | proportion of participants (Number) |
---|
Standard Counseling Arm | 0.14 |
Behavioral Intervention Arm Only | 0.42 |
Behavioral Intervention Plus ARV | 0.15 |
[back to top]
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis (NCT01450189)
Timeframe: 26 weeks
Intervention | proportion of participants (Number) |
---|
Standard Counseling Arm | 0.14 |
Behavioral Intervention Arm Only | 0.33 |
Behavioral Intervention Plus ARV | 0.12 |
[back to top]
Genital HIV RNA Concentration - Week 12, Women
median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 12 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 82.5 |
Behavioral Intervention Arm Only | 0 |
Behavioral Intervention Plus ARV | 38.5 |
[back to top]
Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded. (NCT01450189)
Timeframe: 26 weeks
Intervention | Proportion of participants (Number) |
---|
Standard Counseling Arm | 0.5 |
Behavioral Intervention Arm Only | 0.5 |
Behavioral Intervention Plus ARV | 0.25 |
[back to top]
Genital HIV RNA Concentration - Week 26, Men
median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 26 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 9456 |
Behavioral Intervention Arm Only | 292 |
Behavioral Intervention Plus ARV | 0 |
[back to top]
Genital HIV RNA Concentration - Week 26, Women
median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 26 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 11.5 |
Behavioral Intervention Arm Only | 0 |
Behavioral Intervention Plus ARV | 164 |
[back to top]
Genital HIV RNA Concentration - Week 52, Men
median HIV RNA concentration as measured in semen (NCT01450189)
Timeframe: 52 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 13088 |
Behavioral Intervention Arm Only | 66 |
Behavioral Intervention Plus ARV | 0 |
[back to top]
Genital HIV RNA Concentration - Week 52, Women
median HIV RNA concentration in cervical lavage fluid (NCT01450189)
Timeframe: 52 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 0 |
Behavioral Intervention Arm Only | 219 |
Behavioral Intervention Plus ARV | 2111 |
[back to top]
Blood HIV RNA Concentration at Week 26
(NCT01450189)
Timeframe: 26 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 8661 |
Behavioral Intervention Arm Only | 58504 |
Behavioral Intervention Plus ARV | 6788 |
[back to top]
Number of Adverse Events
Mean number of adverse events per group (NCT01450189)
Timeframe: one year
Intervention | number of events (Mean) |
---|
Standard Counseling Arm | 0.78 |
Behavioral Intervention Arm Only | 1.3 |
Behavioral Intervention Plus ARV | 1.3 |
[back to top]
Blood HIV RNA Concentration at Week 12
(NCT01450189)
Timeframe: 12 weeks
Intervention | copies/ml (Median) |
---|
Standard Counseling Arm | 19411 |
Behavioral Intervention Arm Only | 22734 |
Behavioral Intervention Plus ARV | 20 |
[back to top]
Occurrence of Grade 3 or Higher Adverse Events (AEs)
participants had Occurrence of Grade 3 or higher adverse events (AEs) (NCT01505114)
Timeframe: Through Week 48
Intervention | Participants (Count of Participants) |
---|
Arm 1 | 18 |
Arm 2 | 24 |
Arm 3 | 20 |
Arm 4 | 28 |
[back to top]
Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48
(NCT01605890)
Timeframe: at Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 3 |
[back to top]
Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24
(NCT01605890)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 5 |
[back to top]
Number of Virological Failure Participants With Resistance Mutations
Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported. (NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 1 |
[back to top]
Number of Participants With Treatment Switch or Discontinuation
Overall (regardless of the molecule) (NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 4 |
[back to top]
Number of Clinical and Biological Events
(NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | clinical and biological events (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 61 |
[back to top]
Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL
(NCT01605890)
Timeframe: between Week 0 and Week 48
Intervention | percentage of participants (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 96.4 |
[back to top]
Number of Participants With Clinical Progression
"Clinical progression is defined as the switch:~from category A to B, C or death.~from category B to C or death." (NCT01605890)
Timeframe: from Week 0 to Week 48
Intervention | Participants (Count of Participants) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 0 |
[back to top]
[back to top]
Percentage of Participants in Therapeutic Success
"The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:~Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,~CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,~Raltegravir permanent discontinuation,~Death from any cause,~New B or C events confirmed by an endpoint review committee" (NCT01605890)
Timeframe: at Week 48
Intervention | percentage of participants (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 40 |
[back to top]
[back to top]
Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence
(NCT01605890)
Timeframe: from Week 4 to Week 48
Intervention | percentage of participants (Number) |
---|
Raltegravir / Emtricitabine / Tenofovir Disoproxil Fumarate | 76 |
[back to top]
[back to top]
Change in log10(Pf Parasite Density) From Entry to Day 30
"Change is evaluated as log10(Pf parasite density) at day 30 minus log10(Pf parasite density) at entry.~Change is evaluated in four groups:~Randomized to nNRTI-based ART with continued Pf SCP at day 15~Randomized to nNRTI-based ART with clearance of Pf SCP at day 15~Randomized to LPV/r-based ART with continued Pf SCP at day 15~Randomized to LPV/r-based ART with clearance of Pf SCP at day 15" (NCT01632891)
Timeframe: Entry, Day 30
Intervention | log10(parasites/µL) (Median) |
---|
nNRTI-based ART, Not Cleared | -2.26 |
nNRTI-based ART, Cleared | -1.65 |
LPV/R-based ART, Not Cleared | -1.82 |
LPV/R-based ART, Cleared | -3.61 |
[back to top]
Number of Participants With Uncomplicated Clinical Malaria
Uncomplicated clinical malaria is defined as the presence of non-severe fever/symptoms and parasitemia without organ complication. (NCT01632891)
Timeframe: From study entry to day 30
Intervention | Participants (Count of Participants) |
---|
LPV/R-based ART | 2 |
nNRTI-based ART | 1 |
[back to top]
Time to First Pf SCP Clearance
Time to clearance is defined by time to first measurement with PCR < 10 parasites/µL, and is evaluated as the point estimate and 95% CI for the day when 50% of participants cleared parasite. (NCT01632891)
Timeframe: From study entry up to day 30
Intervention | Days (Median) |
---|
LPV/R-based ART | 12 |
nNRTI-based ART | 14 |
[back to top]
Number of Participants With Detectable Pf Gametocyte Density
Number of participants with detectable Pf gametocyte density as determined by PCR. Due to the large number of undetectable results, this outcome was measured as dichotomous. (NCT01632891)
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30
Intervention | Participants (Count of Participants) |
---|
| Entry | Day 3 | Day 6 | Day 9 | Day 12 | Day 15 | Day 20 | Day 25 | Day 30 |
---|
LPV/R-based ART | 11 | 10 | 9 | 11 | 6 | 10 | 11 | 12 | 11 |
,nNRTI-based ART | 12 | 15 | 12 | 13 | 11 | 14 | 14 | 16 | 13 |
[back to top]
Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance
"Pf SCP clearance defined by polymerase chain reaction (PCR) < 10 parasites/µL on three consecutive occasions within a 24-hour period.~If a participant had missing data on day 15, they were considered as not having clearance." (NCT01632891)
Timeframe: Day 15 (3 samples collected, separated by at least 5 hours and all three collected within 24-hours)
Intervention | Proportion of participants (Number) |
---|
| Proportion Cleared | Proportion Not Cleared |
---|
LPV/R-based ART | 0.23 | 0.77 |
,nNRTI-based ART | 0.27 | 0.73 |
[back to top]
Log10(Pf Parasite Density)
Pf parasite density was determined by PCR. If parasite density equals 0, the value is set to 0.01 before log10 transformation. The value 0.01 was chosen based on the smallest observed parasite density value of 0.017. (NCT01632891)
Timeframe: Entry, days 3, 6, 9, 12, 15, 20, 25, 30
Intervention | log10(parasites/µL) (Mean) |
---|
| Entry | Day 3 | Day 6 | Day 9 | Day 12 | Day 15 | Day 20 | Day 25 | Day 30 |
---|
LPV/R-based ART | 2.48 | 1.92 | 1.77 | 1.65 | 1.59 | 1.59 | 0.65 | 0.28 | 0.14 |
,nNRTI-based ART | 2.09 | 1.57 | 1.49 | 1.63 | 1.56 | 1.43 | 0.67 | 0.49 | 0.30 |
[back to top]
Change in log10(Pf Gametocyte Density) From Entry to Day 30
"Change in log10(Pf gametocyte density) as evaluated using a Hodges-Lehmann estimate from entry to day 30 is evaluated in two groups:~Randomized to nNRTI-based ART with continued Pf SCP at day 15~Randomized to LPV/r-based ART with continued Pf SCP at day 15~Analysis was not conducted in either group with clearance at day 15 due to the small sample size and high number of undetectable samples in both clearance groups at entry and day 30." (NCT01632891)
Timeframe: Entry, Day 30
Intervention | log10(gametocyte/µL) (Number) |
---|
nNRTI-based ART, Not Cleared | -0.46 |
LPV/R-based ART, Not Cleared | 0.17 |
[back to top]
Percent of Participants With Treatment Modification or Discontinuation by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 19.9 |
Experimental: Sub-cohort B1 | 6.8 |
Experimental: Sub-cohort B2 | 19.4 |
Experimental: Sub-cohort B3 | 12.5 |
Experimental: Cohort C | 14.3 |
Experimental: Cohort D | 11.8 |
[back to top]
Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 19.1 |
Standard of Care (SOC) | 13.6 |
[back to top]
Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 3.2 |
Experimental: Sub-cohort B1 | 2.7 |
Experimental: Sub-cohort B2 | 1.4 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 4.3 |
Experimental: Cohort D | 0 |
[back to top]
Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 2.8 |
Standard of Care (SOC) | 2.3 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks
"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 24 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Overall Study | 0.64 |
Experimental: Cohort A | 0.43 |
Experimental: Sub-cohort B1 | 0.89 |
Experimental: Sub-cohort B2 | 0.88 |
Experimental: Sub-cohort B3 | 1.00 |
Experimental: Cohort C | 0.90 |
Experimental: Cohort D | 0.74 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]
"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 24 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.68 |
Standard of Care (SOC) | 0.61 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks
"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 48 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Overall Study | 0.64 |
Experimental: Cohort A | 0.44 |
Experimental: Sub-cohort B1 | 0.88 |
Experimental: Sub-cohort B2 | 0.88 |
Experimental: Sub-cohort B3 | 1.00 |
Experimental: Cohort C | 0.90 |
Experimental: Cohort D | 0.74 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]
"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 48 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.66 |
Standard of Care (SOC) | 0.62 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks
"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided." (NCT01641367)
Timeframe: 72 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Overall Study | 0.64 |
Experimental: Cohort A | 0.44 |
Experimental: Sub-cohort B1 | 0.92 |
Experimental: Sub-cohort B2 | 0.87 |
Experimental: Sub-cohort B3 | 1.00 |
Experimental: Cohort C | 0.85 |
Experimental: Cohort D | 0.77 |
[back to top]
Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]
"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL." (NCT01641367)
Timeframe: 72 weeks after the date of entry
Intervention | proportion of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.69 |
Standard of Care (SOC) | 0.62 |
[back to top]
Change From Baseline in CD4+ T-cell Count
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
Intervention | cells/mm^3 (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Experimental: Cohort A | 39 | 65 | 87 |
,Experimental: Cohort C | 100 | 160 | 185 |
,Experimental: Cohort D | 90 | 135 | 165 |
,Experimental: Sub-cohort B1 | 109 | 157 | 182 |
,Experimental: Sub-cohort B2 | 116 | 158 | 197 |
,Experimental: Sub-cohort B3 | 142 | 86 | 238 |
[back to top]
Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
Intervention | cells/mm^3 (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 72 | 112 | 145 |
,Standard of Care (SOC) | 74 | 107 | 134 |
[back to top]
Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 15.3 | 2.2 | 13.7 |
,Standard of Care (SOC) | 18.7 | 19.6 | 7.1 |
[back to top]
Change From Baseline in Fasting Values of Triglycerides
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Experimental: Cohort A | 15.4 | 12.2 | 17.5 |
,Experimental: Cohort C | 15.4 | 9.9 | 11.8 |
,Experimental: Cohort D | 28.9 | 24.4 | 6.7 |
,Experimental: Sub-cohort B1 | -3.6 | -11.5 | -31.3 |
,Experimental: Sub-cohort B2 | 27.6 | 19.9 | 18.9 |
,Experimental: Sub-cohort B3 | 36.0 | 22.2 | 20.7 |
[back to top]
Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 10.1 | 15.1 | 17.4 |
,Standard of Care (SOC) | 14.4 | 14.1 | 18.7 |
[back to top]
Change From Baseline in Fasting Values of Total Cholesterol
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Experimental: Cohort A | 5.7 | 4.4 | 7.6 |
,Experimental: Cohort C | 16.5 | 20.0 | 22.1 |
,Experimental: Cohort D | 7.9 | 19.1 | 24.5 |
,Experimental: Sub-cohort B1 | 16.7 | 19.7 | 22.6 |
,Experimental: Sub-cohort B2 | 32.5 | 40.4 | 40.4 |
,Experimental: Sub-cohort B3 | 12.4 | 9.9 | 28.2 |
[back to top]
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 2.9 | 5.6 | 6.0 |
,Standard of Care (SOC) | 3.6 | 3.7 | 6.6 |
[back to top]
Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 0.4 |
Standard of Care (SOC) | 1.1 |
[back to top]
Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 2.3 | 11.3 | 44.6 | 168.9 |
,Standard of Care (SOC) | 2.3 | 20.3 | 45.3 | NA |
[back to top]
Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)] (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Experimental: Cohort A | 2.8 | 3.5 | 4.7 |
,Experimental: Cohort C | 1.0 | 2.3 | 5.8 |
,Experimental: Cohort D | -2.2 | 1.8 | 3.4 |
,Experimental: Sub-cohort B1 | 3.2 | 5.3 | 4.4 |
,Experimental: Sub-cohort B2 | 11.4 | 13.4 | 15.7 |
,Experimental: Sub-cohort B3 | 2.1 | 3.8 | 4.6 |
[back to top]
Change From Baseline in Fasting Values of Glucose
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Experimental: Cohort A | 1.9 | 2.1 | 3.0 |
,Experimental: Cohort C | 2.1 | 3.0 | -0.9 |
,Experimental: Cohort D | 3.2 | 4.2 | 7.8 |
,Experimental: Sub-cohort B1 | 8.8 | 9.3 | 6.8 |
,Experimental: Sub-cohort B2 | 6.1 | 6.2 | -5.2 |
,Experimental: Sub-cohort B3 | 6.6 | 1.7 | 4.3 |
[back to top]
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 3.1 | NA |
,Standard of Care (SOC) | 9.0 | NA |
[back to top]
Time From Study Entry/Randomization to Treatment Modification or Discontinuation.
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile |
---|
Experimental: Cohort A | 1.0 | 8.4 | 25.3 | 58.6 | NA |
,Experimental: Cohort C | 0.1 | 4.1 | 29.7 | NA | NA |
,Experimental: Cohort D | 2.4 | 5.1 | 47.6 | 98.9 | NA |
,Experimental: Sub-cohort B1 | 3.1 | 33.4 | 59.0 | NA | NA |
,Experimental: Sub-cohort B2 | 4.4 | 36.0 | 38.6 | 165.6 | NA |
,Experimental: Sub-cohort B3 | 4.4 | 4.4 | 4.4 | NA | NA |
[back to top]
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile |
---|
Experimental: Cohort A | 24 | 24 | 24 | 24 | 60 |
,Experimental: Cohort C | 24 | 48 | 120 | NA | NA |
,Experimental: Cohort D | 24 | 24 | 24 | NA | NA |
,Experimental: Sub-cohort B1 | 24 | 48 | NA | NA | NA |
,Experimental: Sub-cohort B2 | 24 | 72 | 144 | NA | NA |
,Experimental: Sub-cohort B3 | NA | NA | NA | NA | NA |
[back to top]
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 24 | 24 | 24 | 60 | NA |
,Standard of Care (SOC) | 24 | 24 | 24 | 24 | NA |
[back to top]
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A) (NCT01641367)
Timeframe: Baseline, week 24, 48 and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Experimental: Cohort A | 1.3 | 3.4 | 3.9 |
,Experimental: Cohort C | 12.2 | 15.3 | 13.6 |
,Experimental: Cohort D | 9.9 | 14.4 | 19.7 |
,Experimental: Sub-cohort B1 | 13.3 | 16.3 | 22.4 |
,Experimental: Sub-cohort B2 | 21.5 | 28.2 | 27.8 |
,Experimental: Sub-cohort B3 | -0.5 | 0.3 | 16.6 |
[back to top]
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 4.0 | 27.6 | 60.6 | NA |
,Standard of Care (SOC) | 4.0 | 42.3 | 77.9 | NA |
[back to top]
Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 1.0 | 5.1 | 23.6 | 84.0 |
,Standard of Care (SOC) | 2.4 | 22.3 | 38.9 | 111.1 |
[back to top]
Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity
Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile |
---|
Experimental: Cohort A | 2.1 | 106.1 | NA |
,Experimental: Cohort C | 0.1 | NA | NA |
,Experimental: Cohort D | NA | NA | NA |
,Experimental: Sub-cohort B1 | 15.0 | NA | NA |
,Experimental: Sub-cohort B2 | 6.4 | 134.0 | NA |
,Experimental: Sub-cohort B3 | NA | NA | NA |
[back to top]
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile |
---|
Experimental: Cohort A | 24 | 24 | 24 | 144 |
,Experimental: Cohort C | 48 | NA | NA | NA |
,Experimental: Cohort D | 24 | 24 | 24 | NA |
,Experimental: Sub-cohort B1 | 24 | NA | NA | NA |
,Experimental: Sub-cohort B2 | 24 | NA | NA | NA |
,Experimental: Sub-cohort B3 | NA | NA | NA | NA |
[back to top]
Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 24 | 24 | NA | NA |
,Standard of Care (SOC) | 24 | 24 | 48 | NA |
[back to top]
Time to First Dose Modification Due to Grade 3 or 4 Toxicity
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
Experimental: Cohort A | 45.7 | NA |
,Experimental: Cohort C | NA | NA |
,Experimental: Cohort D | NA | NA |
,Experimental: Sub-cohort B1 | 63.3 | NA |
,Experimental: Sub-cohort B2 | NA | NA |
,Experimental: Sub-cohort B3 | NA | NA |
[back to top]
Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]
Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 45.7 | NA |
,Standard of Care (SOC) | NA | NA |
[back to top]
Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 5.5 | 12.0 | 11.9 |
,Standard of Care (SOC) | 9.5 | 10.1 | 12.8 |
[back to top]
Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 10.6 |
Standard of Care (SOC) | 10.6 |
[back to top]
Percent of Participants With Death or Hospitalization by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 12.3 |
Experimental: Sub-cohort B1 | 8.1 |
Experimental: Sub-cohort B2 | 9.7 |
Experimental: Sub-cohort B3 | 12.5 |
Experimental: Cohort C | 5.7 |
Experimental: Cohort D | 5.9 |
[back to top]
Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 7.8 |
Standard of Care (SOC) | 12.1 |
[back to top]
Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 to Week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 16.6 |
Experimental: Sub-cohort B1 | 1.4 |
Experimental: Sub-cohort B2 | 1.4 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 1.5 |
Experimental: Cohort D | 15.4 |
[back to top]
Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. (NCT01641367)
Timeframe: From week 24 to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 24.9 |
Standard of Care (SOC) | 32.2 |
[back to top]
Percent of Participants With Confirmed Virologic Failure by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 to Week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 48.9 |
Experimental: Sub-cohort B1 | 8.2 |
Experimental: Sub-cohort B2 | 2.9 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 5.8 |
Experimental: Cohort D | 18.6 |
[back to top]
Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 1.2 |
Standard of Care (SOC) | 0 |
[back to top]
Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used. (NCT01641367)
Timeframe: From study entry to week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 1.0 |
Experimental: Sub-cohort B1 | 0 |
Experimental: Sub-cohort B2 | 0 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 0 |
Experimental: Cohort D | 0 |
[back to top]
Time From Study Entry/Randomization to the First of Death or Hospitalization.
Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile | 50th percentile |
---|
Experimental: Cohort A | 2.4 | 13.4 | 32.6 | 120.1 | 168.9 |
,Experimental: Cohort C | 2.0 | 7.7 | 77.9 | NA | NA |
,Experimental: Cohort D | 2.3 | 5.6 | 96.1 | NA | NA |
,Experimental: Sub-cohort B1 | 2.3 | 20.3 | 80.7 | NA | NA |
,Experimental: Sub-cohort B2 | 3.0 | 28.0 | 49.7 | NA | NA |
,Experimental: Sub-cohort B3 | 16.4 | 16.4 | 16.4 | NA | NA |
[back to top]
Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event
Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile | 25th percentile |
---|
Experimental: Cohort A | 4.0 | 27.6 | 57.9 | NA |
,Experimental: Cohort C | 3.3 | 36.0 | 77.9 | 142.4 |
,Experimental: Cohort D | 2.4 | 24.0 | 48.4 | 96.3 |
,Experimental: Sub-cohort B1 | 3.1 | 36.0 | 84.0 | NA |
,Experimental: Sub-cohort B2 | 16.3 | 50.3 | 120.0 | NA |
,Experimental: Sub-cohort B3 | NA | NA | NA | NA |
[back to top]
Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | NA | NA |
,Standard of Care (SOC) | 25.0 | NA |
[back to top]
Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)
Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile |
---|
Experimental: Cohort A | NA | NA |
,Experimental: Cohort C | NA | NA |
,Experimental: Cohort D | 13.0 | NA |
,Experimental: Sub-cohort B1 | NA | NA |
,Experimental: Sub-cohort B2 | 25.0 | NA |
,Experimental: Sub-cohort B3 | NA | NA |
[back to top]
Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]
Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen. (NCT01641367)
Timeframe: Baseline, week 24, 48, and 72
Intervention | mg/dL (Mean) |
---|
| Change from baseline at week 24 | Change from baseline at week 48 | Change from baseline at week 72 |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 3.7 | 3.6 | 3.6 |
,Standard of Care (SOC) | 3.7 | 5.1 | 1.5 |
[back to top]
Time From Study Entry/Randomization to Death [CPI+SOC v SOC]
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 11.3 | NA | NA |
,Standard of Care (SOC) | 15.9 | 82.1 | NA |
[back to top]
Time From Study Entry/Randomization to Death
Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | weeks (Number) |
---|
| 1st percentile | 5th percentile | 10th percentile |
---|
Experimental: Cohort A | 11.3 | 62.4 | NA |
,Experimental: Cohort C | 77.9 | NA | NA |
,Experimental: Cohort D | 2.4 | NA | NA |
,Experimental: Sub-cohort B1 | 3.1 | NA | NA |
,Experimental: Sub-cohort B2 | 44.6 | NA | NA |
,Experimental: Sub-cohort B3 | NA | NA | NA |
[back to top]
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | Participants (Count of Participants) |
---|
Experimental: Cohort A | 145 |
Experimental: Sub-cohort B1 | 6 |
Experimental: Sub-cohort B2 | 4 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 5 |
Experimental: Cohort D | 6 |
[back to top]
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | Participants (Count of Participants) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 66 |
Standard of Care (SOC) | 89 |
[back to top]
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | Participants (Count of Participants) |
---|
Experimental: Cohort A | 48 |
Experimental: Sub-cohort B1 | 1 |
Experimental: Sub-cohort B2 | 2 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 1 |
Experimental: Cohort D | 5 |
[back to top]
Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]
Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry. (NCT01641367)
Timeframe: From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks
Intervention | Participants (Count of Participants) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 20 |
Standard of Care (SOC) | 32 |
[back to top]
Number of Weeks of Follow-up
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up
Intervention | weeks (Median) |
---|
Experimental: Cohort A | 72 |
Experimental: Sub-cohort B1 | 96 |
Experimental: Sub-cohort B2 | 84 |
Experimental: Sub-cohort B3 | 96 |
Experimental: Cohort C | 72 |
Experimental: Cohort D | 96 |
[back to top]
Number of Weeks of Follow-up [CPI+SOC v SOC]
All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. (NCT01641367)
Timeframe: From study entry through Step 1/2 follow-up
Intervention | weeks (Median) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 72 |
Standard of Care (SOC) | 72 |
[back to top]
Percent of Participants Experiencing Death by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 3.9 |
Experimental: Sub-cohort B1 | 1.4 |
Experimental: Sub-cohort B2 | 1.4 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 0 |
Experimental: Cohort D | 2.9 |
[back to top]
Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 3.9 |
Standard of Care (SOC) | 1.5 |
[back to top]
Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 8.8 |
Experimental: Sub-cohort B1 | 5.4 |
Experimental: Sub-cohort B2 | 4.2 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 5.8 |
Experimental: Cohort D | 5.9 |
[back to top]
Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. (NCT01641367)
Timeframe: From study entry to Week 48
Intervention | percentage of participants (Number) |
---|
Cell Phone Intervention (CPI) + Standard of Care (SOC) | 8.2 |
Standard of Care (SOC) | 6.5 |
[back to top]
Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48
Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. (NCT01641367)
Timeframe: From study entry to week 48
Intervention | percentage of participants (Number) |
---|
Experimental: Cohort A | 0.7 |
Experimental: Sub-cohort B1 | 0 |
Experimental: Sub-cohort B2 | 1.4 |
Experimental: Sub-cohort B3 | 0 |
Experimental: Cohort C | 0 |
Experimental: Cohort D | 3.0 |
[back to top]
Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Giga cells per liter (Mean) |
---|
| T. neutrophils; Baseline; n=60, 60, 61, 62 | T. neutrophils; Week 2; n=57, 56, 59, 59 | T. neutrophils; Week 4; n=57, 57, 59, 57 | T. neutrophils; Week 8; n=58, 56, 56, 55 | T. neutrophils; Week 12; n=58, 53, 57, 51 | T. neutrophils; Week 16; n=57, 54, 57, 52 | T. neutrophils; Week 20; n=56, 54, 55, 49 | T. neutrophils; Week 24; n=56, 53, 56, 47 | T. neutrophils; Week 26; n=48, 50, 53, 45 | T. neutrophils; Week 28; n=50, 52, 52, 45 | T. neutrophils; Week 32; n=51, 53, 55, 45 | T. neutrophils; Week 36; n=52, 53, 55, 44 | T. neutrophils; Week 40; n=51, 53, 55, 45 | T. neutrophils; Week 48; n=51, 53, 54, 44 | T. neutrophils; Week 60; n=48, 47, 52, 44 | T. neutrophils; Week 72; n=47, 48, 52, 42 | T. neutrophils; Week 84; n=46, 48, 51, 42 | T. neutrophils; Week 96; n=46, 46, 52, 41 | Platelet count; Baseline; n=60, 60, 61, 62 | Platelet count; Week 2; n=57, 56, 59, 59 | Platelet count; Week 4; n=57, 57, 59, 57 | Platelet count; Week 8; n=58, 56, 56, 55 | Platelet count; Week 12; n=58, 53, 57, 51 | Platelet count; Week 16; n=57, 54, 57, 52 | Platelet count; Week 20; n=56, 54, 55, 49 | Platelet count; Week 24; n=56, 53, 56, 47 | Platelet count; Week 26; n=48, 50, 53, 45 | Platelet count; Week 28; n=50, 52, 52, 45 | Platelet count; Week 32; n=51, 52, 55, 45 | Platelet count; Week 36; n=52, 53, 55, 44 | Platelet count; Week 40; n=51, 53, 54, 45 | Platelet count; Week 48; n=51, 52, 53, 44 | Platelet count; Week 60; n=48, 47, 51, 44 | Platelet count; Week 72; n=47, 48, 52, 42 | Platelet count; Week 84; n=46, 48, 51, 42 | Platelet count; Week 96; n=46, 45, 51, 41 | WBC count; Baseline; n=60, 60, 61, 62 | WBC count; Week 2; n=57, 56, 59, 59 | WBC count; Week 4; n=57, 57, 59, 57 | WBC count; Week 8; n=58, 56, 56, 55 | WBC count; Week 12; n=58, 53, 57, 51 | WBC count; Week 16; n=57, 54, 57, 52 | WBC count; Week 20; n=56, 54, 55, 49 | WBC count; Week 24; n=56, 53, 56, 47 | WBC count; Week 26; n=48, 50, 53, 45 | WBC count; Week 28; n=50, 52, 52, 45 | WBC count; Week 32; n=51, 53, 55, 45 | WBC count; Week 36; n=52, 53, 55, 44 | WBC count; Week 40; n=51, 53, 55, 45 | WBC count; Week 48; n=51, 53, 54, 44 | WBC count; Week 60; n=48, 47, 52, 44 | WBC count; Week 72; n=47, 48, 52, 42 | WBC count; Week 84; n=46, 48, 51, 42 | WBC count; Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 2.441 | 3.207 | 2.848 | 2.746 | 2.979 | 2.858 | 3.187 | 3.142 | 2.886 | 2.916 | 3.174 | 2.914 | 3.187 | 3.134 | 3.269 | 3.361 | 3.259 | 3.297 | 200.1 | 216.2 | 216.0 | 209.8 | 213.7 | 211.4 | 214.9 | 220.9 | 214.4 | 215.4 | 212.6 | 209.8 | 217.7 | 220.3 | 230.5 | 225.9 | 216.5 | 214.0 | 4.70 | 5.45 | 5.02 | 5.02 | 5.27 | 5.13 | 5.50 | 5.34 | 5.08 | 5.14 | 5.48 | 5.17 | 5.51 | 5.53 | 5.75 | 5.84 | 5.78 | 5.75 |
,GSK1265744 10 mg | 2.643 | 2.723 | 2.685 | 2.899 | 2.812 | 3.078 | 2.958 | 3.151 | 2.885 | 3.183 | 2.797 | 3.162 | 3.155 | 3.138 | 3.164 | 3.197 | 3.245 | 3.466 | 212.5 | 225.0 | 225.2 | 224.5 | 227.2 | 230.0 | 231.3 | 226.1 | 224.9 | 223.3 | 220.5 | 220.0 | 224.9 | 225.6 | 232.5 | 234.0 | 224.8 | 237.1 | 5.06 | 5.32 | 5.24 | 5.44 | 5.41 | 5.56 | 5.46 | 5.57 | 5.30 | 5.71 | 5.30 | 5.64 | 5.63 | 5.51 | 5.73 | 5.80 | 5.91 | 6.14 |
,GSK1265744 30 mg | 2.891 | 2.776 | 2.771 | 2.802 | 2.933 | 2.716 | 2.904 | 2.996 | 2.958 | 3.005 | 3.036 | 2.916 | 3.065 | 3.132 | 3.333 | 3.131 | 3.385 | 3.540 | 202.3 | 222.0 | 222.4 | 228.4 | 216.4 | 212.4 | 215.5 | 219.7 | 215.5 | 217.0 | 214.0 | 212.1 | 210.1 | 221.2 | 219.8 | 224.4 | 218.8 | 221.8 | 5.19 | 5.30 | 5.17 | 5.30 | 5.50 | 5.20 | 5.41 | 5.53 | 5.50 | 5.53 | 5.63 | 5.48 | 5.61 | 5.72 | 5.93 | 5.71 | 6.11 | 6.15 |
,GSK1265744 60 mg | 2.487 | 2.598 | 2.649 | 2.738 | 2.822 | 2.665 | 2.989 | 2.884 | 2.830 | 2.989 | 3.167 | 3.010 | 3.050 | 3.004 | 3.200 | 3.163 | 3.512 | 3.494 | 190.0 | 204.8 | 204.6 | 211.5 | 209.2 | 209.5 | 205.4 | 210.9 | 199.4 | 209.8 | 207.8 | 204.2 | 199.3 | 209.9 | 212.2 | 212.2 | 210.1 | 210.6 | 4.72 | 5.02 | 5.02 | 5.04 | 5.34 | 4.97 | 5.39 | 5.28 | 5.29 | 5.38 | 5.57 | 5.56 | 5.45 | 5.41 | 5.63 | 5.73 | 6.05 | 6.01 |
[back to top]
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 47, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=36, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=31, 39, 45, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 45, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=31, 37, 44, 0 | Week 312; n=31, 33, 43, 0 | Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 4.424 | 1.883 | 1.706 | 1.695 | 1.643 | 1.619 | 1.623 | 1.615 | 1.595 | 1.591 | 1.609 | 1.604 | 1.612 | 1.686 | 1.648 | 1.625 | 1.645 | 1.681 | 1.634 | 1.638 | 1.646 | 1.682 | 1.634 | 1.665 | 1.613 | 1.689 | 1.628 | 1.591 | 1.591 | 1.596 | 1.591 | 1.591 | 1.591 | 1.591 | 1.601 | 1.597 | 1.591 |
,GSK1265744 30 mg | 4.270 | 1.984 | 1.731 | 1.666 | 1.618 | 1.602 | 1.596 | 1.597 | 1.602 | 1.607 | 1.620 | 1.610 | 1.618 | 1.654 | 1.598 | 1.697 | 1.643 | 1.603 | 1.609 | 1.591 | 1.631 | 1.698 | 1.603 | 1.642 | 1.591 | 1.591 | 1.595 | 1.592 | 1.591 | 1.601 | 1.599 | 1.591 | 1.591 | 1.592 | 1.591 | 1.600 | 1.591 |
,GSK1265744 60 mg | 4.428 | 1.939 | 1.725 | 1.666 | 1.641 | 1.616 | 1.599 | 1.603 | 1.594 | 1.591 | 1.618 | 1.606 | 1.608 | 1.598 | 1.594 | 1.591 | 1.592 | 1.596 | 1.591 | 1.618 | 1.591 | 1.630 | 1.619 | 1.603 | 1.600 | 1.699 | 1.634 | 1.634 | 1.625 | 1.591 | 1.593 | 1.617 | 1.618 | 1.591 | 1.625 | 1.591 | 1.591 |
[back to top]
Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 4.290 | 2.415 | 2.201 | 1.950 | 1.758 | 1.697 | 1.649 | 1.610 | 1.610 | 1.600 | 1.614 | 1.607 | 1.607 | 1.596 | 1.657 | 1.592 | 1.591 | 1.598 |
[back to top]
Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Grams per liter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=57, 57, 59, 57 | Week 8; n=58, 56, 56, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 55, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=50, 52, 52, 45 | Week 32; n=51, 53, 55, 45 | Week 36; n=52, 53, 55, 44 | Week 40; n=51, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 52, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 51, 42 | Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 145.4 | 146.4 | 146.6 | 148.1 | 149.2 | 147.6 | 147.2 | 148.5 | 148.2 | 145.9 | 145.9 | 145.0 | 145.1 | 145.4 | 147.6 | 147.7 | 147.0 | 147.0 |
,GSK1265744 10 mg | 141.9 | 142.0 | 141.9 | 144.9 | 144.3 | 143.5 | 144.3 | 144.8 | 144.4 | 143.7 | 144.6 | 142.3 | 142.2 | 142.9 | 144.5 | 143.9 | 145.6 | 144.9 |
,GSK1265744 30 mg | 143.2 | 142.8 | 143.5 | 147.7 | 147.4 | 146.5 | 146.9 | 147.8 | 145.8 | 146.8 | 146.1 | 145.9 | 145.2 | 145.7 | 148.3 | 148.1 | 147.7 | 147.1 |
,GSK1265744 60 mg | 146.6 | 145.9 | 147.3 | 148.6 | 149.1 | 148.7 | 149.8 | 150.4 | 149.8 | 149.3 | 150.5 | 149.8 | 149.2 | 146.5 | 149.8 | 149.6 | 150.3 | 150.8 |
[back to top]
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 |
---|
GSK1265744 10 mg | 131.0 | 96.0 | 129.3 | 125.0 | 132.4 | 137.0 | 127.9 | 127.0 | 130.8 |
[back to top]
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 |
---|
GSK1265744 60 mg | 128.3 | 122.4 | 143.0 | 123.9 | 120.7 | 122.3 | 116.6 |
[back to top]
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 26; n=0, 1, 0, 0 | Week 40; n=0, 1, 0, 0 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 |
---|
GSK1265744 30 mg | 135.2 | 106.0 | 132.5 | 124.0 | 139.4 | 132.8 | 147.0 | 180.0 | 139.2 | 137.7 |
[back to top]
Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine; Baseline; n=60, 60, 61, 62 | Creatinine; Week 2; n=58, 56, 58, 58 | Creatinine; Week 4; n=58, 57, 59, 57 | Creatinine; Week 8; n=58, 55, 57, 54 | Creatinine; Week 12; n=58, 53, 57, 51 | Creatinine; Week 16; n=57, 54, 57, 52 | Creatinine; Week 20; n=56, 54, 55, 49 | Creatinine; Week 24; n=56, 53, 56, 47 | Creatinine; Week 26; n=48, 50, 53, 45 | Creatinine; Week 28; n=51, 52, 52, 45 | Creatinine; Week 32; n=52, 53, 55, 45 | Creatinine; Week 36; n=52, 52, 55, 45 | Creatinine; Week 40; n=52, 53, 55, 44 | Creatinine; Week 48; n=51, 53, 54, 44 | Creatinine; Week 60; n=48, 47, 53, 44 | Creatinine; Week 72; n=47, 47, 52, 42 | Creatinine; Week 84; n=46, 48, 52, 42 | Creatinine; Week 96; n=45, 48, 52, 40 | T. Bilirubin; Baseline; n=60, 60, 61, 62 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | T. Bilirubin; Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 83.1 | 83.8 | 83.1 | 82.4 | 81.1 | 79.6 | 79.5 | 80.0 | 78.6 | 78.5 | 78.1 | 78.4 | 79.2 | 79.0 | 77.9 | 77.7 | 79.7 | 81.0 | 9.7 | 6.8 | 6.4 | 6.3 | 7.0 | 7.0 | 6.8 | 6.6 | 6.8 | 6.4 | 6.6 | 6.5 | 6.3 | 6.6 | 7.0 | 6.5 | 6.6 | 6.8 |
,GSK1265744 10 mg | 80.4 | 83.8 | 82.9 | 82.9 | 83.8 | 83.4 | 83.2 | 83.2 | 83.4 | 83.0 | 83.8 | 83.5 | 83.3 | 83.4 | 83.9 | 84.5 | 85.0 | 82.0 | 9.2 | 9.2 | 9.4 | 9.3 | 9.5 | 9.6 | 9.0 | 9.6 | 10.6 | 10.3 | 9.8 | 10.3 | 10.8 | 10.0 | 11.2 | 10.8 | 11.7 | 10.3 |
,GSK1265744 30 mg | 80.5 | 83.3 | 83.0 | 82.2 | 82.7 | 82.3 | 82.0 | 83.3 | 82.6 | 83.8 | 82.6 | 84.6 | 83.2 | 83.1 | 83.0 | 86.1 | 84.8 | 86.4 | 9.4 | 9.1 | 9.3 | 9.0 | 8.9 | 8.5 | 9.0 | 9.8 | 9.9 | 10.2 | 9.8 | 10.1 | 11.2 | 9.6 | 9.8 | 10.0 | 9.9 | 9.9 |
,GSK1265744 60 mg | 79.9 | 84.6 | 84.2 | 83.5 | 84.1 | 82.4 | 86.1 | 85.2 | 87.0 | 85.6 | 85.7 | 86.7 | 85.4 | 85.0 | 85.2 | 87.3 | 87.3 | 88.5 | 10.5 | 10.0 | 9.8 | 10.1 | 10.2 | 10.4 | 10.4 | 10.0 | 12.0 | 11.4 | 11.7 | 12.2 | 12.3 | 10.4 | 11.6 | 11.4 | 12.0 | 12.5 |
[back to top]
Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=58, 56, 57, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=49, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 456.5 | 487.0 | 509.9 | 531.4 | 564.3 | 594.4 | 607.7 | 599.5 | 625.7 | 635.7 | 663.8 | 651.5 | 687.9 | 732.6 | 733.9 | 722.5 | 744.7 | 747.8 |
,GSK1265744 10 mg | 445.5 | 544.0 | 580.5 | 576.6 | 588.4 | 608.3 | 607.3 | 614.6 | 632.8 | 652.2 | 638.1 | 638.7 | 650.2 | 677.3 | 668.1 | 683.2 | 718.3 | 726.2 |
,GSK1265744 30 mg | 444.9 | 525.1 | 522.0 | 555.2 | 599.0 | 595.8 | 607.4 | 626.5 | 629.5 | 635.9 | 650.8 | 658.6 | 658.5 | 687.2 | 720.9 | 651.3 | 736.9 | 722.9 |
,GSK1265744 60 mg | 459.0 | 549.3 | 545.8 | 544.3 | 596.6 | 599.7 | 636.6 | 658.0 | 645.8 | 653.3 | 665.2 | 720.3 | 667.6 | 713.8 | 719.8 | 710.9 | 735.0 | 743.1 |
[back to top]
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product. (NCT01641809)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 80 |
GSK1265744 30 mg | 80 |
GSK1265744 60 mg | 87 |
Efavirenz 600 mg | 71 |
[back to top]
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 2 |
GSK1265744 30 mg | 4 |
GSK1265744 60 mg | 2 |
Efavirenz 600 mg | 2 |
[back to top]
Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 0 |
GSK1265744 30 mg | 2 |
GSK1265744 60 mg | 5 |
Efavirenz 600 mg | 13 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Percentage of participants (Number) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | Week 26 | Week 28 | Week 32 | Week 36 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 | Week 108 | Week 120 | Week 132 | Week 144 | Week 156 | Week 168 | Week 180 | Week 192 | Week 204 | Week 216 | Week 228 | Week 240 | Week 252 | Week 264 | Week 276 | Week 288 | Week 300 | Week 312 |
---|
Efavirenz 600 mg | 0 | 13 | 24 | 48 | 61 | 74 | 74 | 66 | 69 | 69 | 71 | 68 | 71 | 68 | 68 | 68 | 63 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 10 mg | 0 | 48 | 80 | 90 | 88 | 90 | 87 | 78 | 85 | 83 | 85 | 83 | 80 | 78 | 72 | 72 | 68 | 68 | 65 | 62 | 58 | 58 | 57 | 58 | 57 | 55 | 55 | 53 | 50 | 52 | 53 | 52 | 50 | 52 | 52 |
,GSK1265744 30 mg | 0 | 50 | 78 | 83 | 75 | 83 | 85 | 75 | 78 | 80 | 82 | 82 | 80 | 73 | 73 | 75 | 75 | 72 | 73 | 70 | 67 | 63 | 65 | 67 | 65 | 62 | 63 | 63 | 62 | 62 | 62 | 62 | 62 | 60 | 52 |
,GSK1265744 60 mg | 0 | 51 | 70 | 87 | 82 | 87 | 87 | 85 | 85 | 87 | 85 | 85 | 87 | 85 | 85 | 85 | 84 | 80 | 80 | 80 | 77 | 80 | 75 | 75 | 74 | 75 | 77 | 75 | 74 | 75 | 75 | 70 | 74 | 70 | 70 |
[back to top]
Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events
AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Percentage of participants (Number) |
---|
GSK1265744 10 mg | 7 |
GSK1265744 30 mg | 7 |
GSK1265744 60 mg | 7 |
Efavirenz 600 mg | 15 |
[back to top]
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
GSK1265744 10 mg | 25 |
GSK1265744 30 mg | 19 |
GSK1265744 60 mg | 15 |
Efavirenz 600 mg | 10 |
[back to top]
Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Intervention | Micrograms per milliliter (Geometric Mean) |
---|
GSK1265744 10 mg | 2.77 |
GSK1265744 30 mg | 7.49 |
GSK1265744 60 mg | 13.12 |
[back to top]
Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2
Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2
Intervention | Micrograms per milliliter (Geometric Mean) |
---|
GSK1265744 10 mg | 1.45 |
GSK1265744 30 mg | 4.34 |
GSK1265744 60 mg | 5.83 |
[back to top]
Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2
Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data (NCT01641809)
Timeframe: pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2
Intervention | Hours*micrograms per milliliter (Geometric Mean) |
---|
GSK1265744 10 mg | 45.69 |
GSK1265744 30 mg | 133.74 |
GSK1265744 60 mg | 227.58 |
[back to top]
Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96
Intervention | Milliliters per minute (Mean) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 60; n=0, 0, 0, 1 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 125.6 | 99.0 | 127.0 | 101.0 | 132.3 | 122.0 | 135.1 | 131.0 | 144.0 | 134.8 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Percentage of participants (Number) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 47, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=36, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=31, 39, 45, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 45, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=31, 37, 44, 0 | Week 312; n=31, 33, 43, 0 | Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 0 | 51 | 83 | 92 | 95 | 95 | 91 | 93 | 98 | 100 | 96 | 98 | 96 | 92 | 94 | 91 | 91 | 89 | 95 | 95 | 95 | 92 | 95 | 94 | 97 | 94 | 97 | 100 | 100 | 97 | 100 | 100 | 100 | 100 | 97 | 100 | 100 |
,GSK1265744 30 mg | 0 | 54 | 82 | 89 | 88 | 94 | 98 | 98 | 94 | 94 | 94 | 96 | 96 | 92 | 96 | 92 | 94 | 98 | 96 | 100 | 96 | 93 | 95 | 95 | 100 | 100 | 97 | 100 | 100 | 97 | 97 | 100 | 100 | 100 | 100 | 97 | 100 |
,GSK1265744 60 mg | 0 | 53 | 73 | 93 | 91 | 93 | 98 | 95 | 98 | 100 | 96 | 95 | 95 | 98 | 98 | 100 | 100 | 98 | 100 | 98 | 100 | 98 | 98 | 98 | 98 | 96 | 98 | 98 | 98 | 100 | 98 | 98 | 96 | 100 | 95 | 100 | 100 |
[back to top]
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 | Week 180; n=1, 0, 0, 0 |
---|
GSK1265744 10 mg | -3.0 | -1.4 | 5.5 | 2.2 | 8.0 | -2.7 | -2.6 | 2.2 | 1.0 |
[back to top]
Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | International Units per Liter (Mean) |
---|
| ALT; Baseline; n=60, 60, 61, 62 | ALT; Week 2; n=58, 56, 58, 58 | ALT; Week 4; n=58, 57, 59, 57 | ALT; Week 8; n=58, 55, 57, 54 | ALT; Week 12; n=58, 53, 57, 51 | ALT; Week 16; n=57, 54, 57, 52 | ALT; Week 20; n=56, 54, 55, 49 | ALT; Week 24; n=56, 53, 56, 47 | ALT; Week 26; n=48, 50, 53, 45 | ALT; Week 28; n=51, 52, 52, 45 | ALT; Week 32; n=52, 53, 55, 45 | ALT; Week 36; n=52, 52, 55, 45 | ALT; Week 40; n=52, 53, 55, 44 | ALT; Week 48; n=51, 53, 54, 44 | ALT; Week 60; n=48, 47, 53, 44 | ALT; Week 72; n=47, 47, 52, 42 | ALT; Week 84; n=46, 48, 52, 42 | ALT; Week 96; n=45, 48, 52, 40 | AST; Baseline; n=60, 60, 61, 62 | AST; Week 2; n=58, 56, 58, 58 | AST; Week 4; n=58, 57, 59, 57 | AST; Week 8; n=58, 55, 57, 54 | AST; Week 12; n=58, 53, 57, 51 | AST; Week 16; n=57, 54, 57, 52 | AST; Week 20; n=56, 54, 55, 49 | AST; Week 24; n=56, 53, 56, 47 | AST; Week 26; n=48, 50, 53, 45 | AST; Week 28; n=51, 52, 52, 45 | AST; Week 32; n=52, 53, 55, 45 | AST; Week 36; n=52, 52, 55, 45 | AST; Week 40; n=52, 53, 55, 44 | AST; Week 48; n=51, 53, 54, 44 | AST; Week 60; n=48, 47, 53, 44 | AST; Week 72; n=47, 47, 52, 42 | AST; Week 84; n=46, 48, 52, 42 | AST; Week 96; n=45, 48, 52, 40 | CK; Baseline; n=60, 60, 61, 62 | CK; Week 2; n=58, 56, 58, 58 | CK; Week 4; n=58, 57, 59, 57 | CK; Week 8; n=58, 55, 57, 54 | CK; Week 12; n=58, 53, 57, 51 | CK; Week 16; n=57, 54, 57, 52 | CK; Week 20; n=56, 54, 55, 49 | CK; Week 24; n=56, 53, 56, 47 | CK; Week 26; n=48, 50, 53, 45 | CK; Week 28; n=51, 52, 52, 45 | CK; Week 32; n=52, 53, 55, 45 | CK; Week 36; n=52, 52, 55, 45 | CK; Week 40; n=52, 53, 55, 44 | CK; Week 48; n=51, 53, 54, 44 | CK; Week 60; n=48, 47, 53, 44 | CK; Week 72; n=47, 47, 52, 42 | CK; Week 84; n=46, 48, 52, 42 | CK; Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 30.5 | 30.0 | 31.4 | 25.0 | 25.7 | 30.4 | 27.0 | 25.7 | 28.3 | 24.2 | 23.1 | 23.5 | 23.4 | 22.6 | 24.9 | 22.7 | 27.1 | 24.3 | 31.5 | 32.8 | 29.0 | 24.4 | 24.4 | 36.7 | 28.7 | 26.1 | 25.8 | 23.7 | 25.4 | 26.3 | 23.0 | 23.7 | 24.9 | 22.9 | 29.9 | 27.7 | 349.8 | 512.1 | 236.2 | 152.9 | 161.2 | 646.5 | 528.2 | 247.4 | 163.5 | 154.7 | 254.7 | 303.1 | 150.2 | 146.3 | 168.0 | 120.5 | 258.6 | 281.1 |
,GSK1265744 10 mg | 23.9 | 24.0 | 23.1 | 25.4 | 25.0 | 26.0 | 22.3 | 20.9 | 24.2 | 20.4 | 19.5 | 23.4 | 22.7 | 18.4 | 21.4 | 19.9 | 20.1 | 22.0 | 25.0 | 25.6 | 24.0 | 28.7 | 26.3 | 24.2 | 26.0 | 23.3 | 28.4 | 22.6 | 21.9 | 29.2 | 24.7 | 21.4 | 23.4 | 21.8 | 22.3 | 23.6 | 197.3 | 237.9 | 196.7 | 413.3 | 316.1 | 195.1 | 342.7 | 226.0 | 344.1 | 213.4 | 205.6 | 528.4 | 259.5 | 203.5 | 315.7 | 182.5 | 204.3 | 542.7 |
,GSK1265744 30 mg | 28.1 | 26.3 | 25.6 | 29.3 | 31.4 | 28.5 | 24.9 | 27.5 | 26.6 | 26.5 | 26.9 | 24.7 | 24.6 | 24.8 | 25.9 | 30.7 | 29.9 | 48.7 | 27.5 | 26.6 | 25.0 | 29.5 | 29.0 | 29.2 | 24.2 | 27.2 | 26.9 | 26.7 | 26.5 | 25.4 | 24.5 | 24.3 | 25.3 | 31.0 | 29.2 | 47.7 | 295.9 | 276.1 | 221.8 | 427.2 | 314.7 | 427.3 | 202.1 | 306.3 | 267.7 | 276.8 | 248.8 | 242.9 | 225.4 | 219.3 | 215.5 | 354.0 | 329.2 | 272.8 |
,GSK1265744 60 mg | 28.5 | 27.2 | 30.3 | 35.9 | 26.6 | 26.9 | 30.3 | 28.6 | 23.5 | 24.8 | 23.2 | 24.2 | 25.8 | 24.8 | 28.1 | 26.3 | 25.3 | 25.5 | 28.1 | 26.8 | 28.3 | 32.8 | 25.5 | 26.5 | 31.7 | 28.6 | 24.5 | 25.5 | 25.6 | 26.4 | 26.5 | 24.2 | 30.4 | 26.4 | 25.2 | 25.9 | 181.2 | 184.8 | 180.5 | 451.7 | 211.8 | 213.3 | 485.3 | 243.0 | 242.5 | 290.4 | 311.3 | 255.2 | 292.6 | 219.8 | 399.6 | 247.7 | 195.0 | 199.7 |
[back to top]
Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | International Units per Liter (Mean) |
---|
| ALT; Week 2; n=58, 56, 58, 58 | ALT; Week 4; n=58, 57, 59, 57 | ALT; Week 8; n=58, 55, 57, 54 | ALT; Week 12; n=58, 53, 57, 51 | ALT; Week 16; n=57, 54, 57, 52 | ALT; Week 20; n=56, 54, 55, 49 | ALT; Week 24; n=56, 53, 56, 47 | ALT; Week 26; n=48, 50, 53, 45 | ALT; Week 28; n=51, 52, 52, 45 | ALT; Week 32; n=52, 53, 55, 45 | ALT; Week 36; n=52, 52, 55, 45 | ALT; Week 40; n=52, 53, 55, 44 | ALT; Week 48; n=51, 53, 54, 44 | ALT; Week 60; n=48, 47, 53, 44 | ALT; Week 72; n=47, 47, 52, 42 | ALT; Week 84; n=46, 48, 52, 42 | ALT; Week 96; n=45, 48, 52, 40 | AST; Week 2; n=58, 56, 58, 58 | AST; Week 4; n=58, 57, 59, 57 | AST; Week 8; n=58, 55, 57, 54 | AST; Week 12; n=58, 53, 57, 50 | AST; Week 16; n=57, 54, 57, 52 | AST; Week 20; n=56, 54, 55, 49 | AST; Week 24; n=56, 53, 56, 47 | AST; Week 26; n=48, 50, 53, 45 | AST; Week 28; n=51, 52, 52, 45 | AST; Week 32; n=52, 53, 55, 45 | AST; Week 36; n=52, 52, 55, 45 | AST; Week 40; n=52, 53, 55, 44 | AST; Week 48; n=51, 53, 54, 44 | AST; Week 60; n=48, 47, 53, 44 | AST; Week 72; n=47, 47, 52, 42 | AST; Week 84; n=46, 48, 52, 42 | AST; Week 96; n=45, 48, 52, 40 | CK; Week 2; n=58, 56, 58, 58 | CK; Week 4; n=58, 57, 59, 57 | CK; Week 8; n=58, 55, 57, 54 | CK; Week 12; n=58, 53, 57, 51 | CK; Week 16; n=57, 54, 57, 52 | CK; Week 20; n=56, 54, 55, 49 | CK; Week 24; n=56, 53, 56, 47 | CK; Week 26; n=48, 50, 53, 45 | CK; Week 28; n=51, 52, 52, 45 | CK; Week 32; n=52, 53, 55, 45 | CK; Week 36; n=52, 52, 55, 45 | CK; Week 40; n=52, 53, 55, 44 | CK; Week 48; n=51, 53, 54, 44 | CK; Week 60; n=48, 47, 53, 44 | CK; Week 72; n=47, 47, 52, 42 | CK; Week 84; n=46, 48, 52, 42 | CK; Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | -1.3 | 0.1 | -6.3 | -6.3 | -1.6 | -4.8 | -6.0 | -3.7 | -8.1 | -8.6 | -8.2 | -8.0 | -8.6 | -6.3 | -8.5 | -4.0 | -7.6 | 0.9 | -2.9 | -7.3 | -7.9 | 4.4 | -3.6 | -2.1 | -2.6 | -5.1 | -2.8 | -1.9 | -5.1 | -4.4 | -3.2 | -4.6 | 2.3 | -0.3 | 159.8 | -120.3 | -212.8 | -220.1 | 269.7 | 135.3 | 103.9 | 21.2 | 4.1 | 110.3 | 158.7 | 3.8 | 2.8 | 24.5 | -14.3 | 123.9 | 143.9 |
[back to top]
Change From Baseline in ALT, AST and CK Over Time by Visit
Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | International Units per Liter (Mean) |
---|
| ALT; Week 2; n=58, 56, 58, 58 | ALT; Week 4; n=58, 57, 59, 57 | ALT; Week 8; n=58, 55, 57, 54 | ALT; Week 12; n=58, 53, 57, 51 | ALT; Week 16; n=57, 54, 57, 52 | ALT; Week 20; n=56, 54, 55, 49 | ALT; Week 24; n=56, 53, 56, 47 | ALT; Week 26; n=48, 50, 53, 45 | ALT; Week 28; n=51, 52, 52, 45 | ALT; Week 32; n=52, 53, 55, 45 | ALT; Week 36; n=52, 52, 55, 45 | ALT; Week 40; n=52, 53, 55, 44 | ALT; Week 48; n=51, 53, 54, 44 | ALT; Week 60; n=48, 47, 53, 44 | ALT; Week 72; n=47, 47, 52, 42 | ALT; Week 84; n=46, 48, 52, 42 | ALT; Week 96; n=45, 48, 52, 40 | ALT; Week 108; n=43, 46, 48, 0 | ALT; Week 120; n=40, 45, 48, 0 | ALT; Week 132; n=40, 46, 49, 0 | ALT; Week 144; n=37, 45, 47, 0 | ALT; Week 156; n=37, 42, 49, 0 | ALT; Week 168; n=35, 43, 47, 0 | ALT; Week 180; n=36, 41, 47, 0 | ALT; Week 192; n=36, 39, 47, 0 | ALT; Week 204; n=34, 39, 47, 0 | ALT; Week 216; n=33, 39, 46, 0 | ALT; Week 228; n=32, 39, 47, 0 | ALT; Week 240; n=30, 39, 46, 0 | ALT; Week 252; n=31, 38, 46, 0 | ALT; Week 264; n=32, 38, 47, 0 | ALT; Week 276; n=31, 38, 45, 0 | ALT; Week 288; n=31, 38, 45, 0 | ALT; Week 300; n=30, 37, 44, 0 | ALT; Week 312; n=31, 34, 43, 0 | ALT; Week 324; n=3, 4, 3, 0 | AST; Week 2; n=58, 56, 58, 58 | AST; Week 4; n=58, 57, 59, 57 | AST; Week 8; n=58, 55, 57, 54 | AST; Week 12; n=58, 53, 57, 50 | AST; Week 16; n=57, 54, 57, 52 | AST; Week 20; n=56, 54, 55, 49 | AST; Week 24; n=56, 53, 56, 47 | AST; Week 26; n=48, 50, 53, 45 | AST; Week 28; n=51, 52, 52, 45 | AST; Week 32; n=52, 53, 55, 45 | AST; Week 36; n=52, 52, 55, 45 | AST; Week 40; n=52, 53, 55, 44 | AST; Week 48; n=51, 53, 54, 44 | AST; Week 60; n=48, 47, 53, 44 | AST; Week 72; n=47, 47, 52, 42 | AST; Week 84; n=46, 48, 52, 42 | AST; Week 96; n=45, 48, 52, 40 | AST; Week 108; n=43, 46, 48, 0 | AST; Week 120; n=40, 45, 48, 0 | AST; Week 132; n=40, 46, 49, 0 | AST; Week 144; n=37, 45, 47, 0 | AST; Week 156; n=37, 42, 49, 0 | AST; Week 168; n=35, 43, 47, 0 | AST; Week 180; n=36, 41, 47, 0 | AST; Week 192; n=36, 39, 47, 0 | AST; Week 204; n=34, 39, 47, 0 | AST; Week 216; n=33, 39, 46, 0 | AST; Week 228; n=32, 39, 47, 0 | AST; Week 240; n=30, 39, 46, 0 | AST; Week 252; n=31, 38, 46, 0 | AST; Week 264; n=32, 38, 47, 0 | AST; Week 276; n=31, 38, 45, 0 | AST; Week 288; n=31, 38, 45, 0 | AST; Week 300; n=30, 37, 44, 0 | AST; Week 312; n=31, 34, 43, 0 | AST; Week 324; n=3, 4, 3, 0 | CK; Week 2; n=58, 56, 58, 58 | CK; Week 4; n=58, 57, 59, 57 | CK; Week 8; n=58, 55, 57, 54 | CK; Week 12; n=58, 53, 57, 51 | CK; Week 16; n=57, 54, 57, 52 | CK; Week 20; n=56, 54, 55, 49 | CK; Week 24; n=56, 53, 56, 47 | CK; Week 26; n=48, 50, 53, 45 | CK; Week 28; n=51, 52, 52, 45 | CK; Week 32; n=52, 53, 55, 45 | CK; Week 36; n=52, 52, 55, 45 | CK; Week 40; n=52, 53, 55, 44 | CK; Week 48; n=51, 53, 54, 44 | CK; Week 60; n=48, 47, 53, 44 | CK; Week 72; n=47, 47, 52, 42 | CK; Week 84; n=46, 48, 52, 42 | CK; Week 96; n=45, 48, 52, 40 | CK; Week 108; n=43, 46, 48, 0 | CK; Week 120; n=40, 45, 48, 0 | CK; Week 132; n=40, 46, 49, 0 | CK; Week 144; n=37, 45, 47, 0 | CK; Week 156; n=37, 42, 49, 0 | CK; Week 168; n=35, 43, 47, 0 | CK; Week 180; n=36, 41, 47, 0 | CK; Week 192; n=36, 39, 47, 0 | CK; Week 204; n=34, 39, 47, 0 | CK; Week 216; n=33, 39, 46, 0 | CK; Week 228; n=32, 39, 47, 0 | CK; Week 240; n=30, 39, 46, 0 | CK; Week 252; n=31, 38, 46, 0 | CK; Week 264; n=32, 38, 47, 0 | CK; Week 276; n=31, 38, 45, 0 | CK; Week 288; n=31, 38, 45, 0 | CK; Week 300; n=30, 37, 44, 0 | CK; Week 312; n=31, 34, 43, 0 | CK; Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 0.1 | -0.7 | 2.2 | 1.2 | 2.1 | -0.7 | -2.1 | 1.1 | -2.3 | -3.1 | 0.8 | 0.1 | -4.1 | -1.0 | -2.8 | -2.4 | -0.4 | 0.5 | 4.4 | 4.3 | 0.1 | -0.5 | 2.3 | 1.7 | 4.9 | 1.9 | 1.7 | 36.8 | 5.3 | 2.0 | 3.3 | 3.3 | 6.6 | 4.8 | 5.5 | 17.7 | 0.7 | -1.0 | 4.2 | 1.3 | -0.7 | 1.3 | -1.4 | 3.3 | -2.0 | -2.7 | 4.6 | 0.1 | -3.3 | -0.9 | -2.7 | -2.2 | -0.8 | -1.0 | 0.1 | -0.2 | -3.4 | -3.0 | -0.8 | -1.9 | -1.5 | -1.7 | -2.7 | 13.5 | -1.0 | -2.2 | -1.6 | -1.5 | -1.4 | -2.0 | 11.7 | 2.7 | 40.0 | -2.3 | 216.9 | 120.6 | -2.0 | 144.2 | 27.5 | 133.7 | 9.8 | 3.1 | 325.9 | 57.1 | -1.3 | 115.4 | -19.8 | -0.7 | 335.4 | 64.2 | 11.5 | 30.6 | 10.6 | -5.3 | 27.7 | 22.4 | 5.2 | 79.1 | 43.2 | 64.0 | 1.2 | 24.6 | 1.9 | 39.9 | 21.6 | 25.3 | 727.5 | -1.3 |
,GSK1265744 30 mg | -2.1 | -2.6 | 0.5 | 2.7 | 0.1 | -3.6 | -1.2 | -2.6 | -2.3 | -1.7 | -4.2 | -4.1 | -3.8 | -2.6 | 2.7 | 1.9 | 20.6 | -2.7 | -2.6 | -3.0 | -3.4 | -1.8 | -1.1 | -2.8 | -3.3 | -1.7 | -3.0 | -1.1 | -0.1 | 2.8 | 0.7 | 2.9 | 1.2 | -1.4 | 7.6 | 1.3 | -1.3 | -2.8 | 1.5 | 1.6 | 1.9 | -3.1 | -0.3 | -0.9 | -0.2 | -1.0 | -2.1 | -2.9 | -3.2 | -2.0 | 3.7 | 2.0 | 20.5 | -4.0 | -2.5 | -3.9 | -4.3 | -3.2 | -3.4 | -4.2 | -5.3 | -4.8 | -4.9 | -5.9 | -5.3 | -2.1 | -4.3 | -3.3 | -3.6 | -5.3 | -2.3 | -5.3 | -32.2 | -82.0 | 115.8 | 39.8 | 156.3 | -68.9 | 32.4 | -16.3 | 74.1 | -25.1 | -33.6 | -48.6 | -54.7 | -80.1 | 53.8 | 33.6 | -22.8 | -88.5 | -48.9 | -41.3 | -72.4 | -87.9 | -60.7 | -16.4 | -98.5 | -101.8 | -74.4 | -129.0 | -108.1 | -110.1 | -31.3 | -126.5 | -98.5 | -100.7 | -141.3 | -195.0 |
,GSK1265744 60 mg | -1.5 | 1.7 | 8.0 | -0.6 | -0.3 | 3.0 | 1.4 | -1.7 | -2.9 | -4.0 | -3.0 | -1.4 | -2.4 | 0.5 | -0.9 | -2.0 | -1.7 | -0.7 | -3.7 | -3.8 | -1.8 | -2.2 | -3.6 | -1.2 | 1.3 | -3.4 | -2.7 | 0.5 | -0.7 | -1.6 | 2.0 | 1.1 | 1.9 | -1.8 | 0.0 | 1.0 | -1.6 | 0.1 | 5.3 | -1.7 | -0.6 | 4.6 | 1.5 | -1.7 | -1.9 | -1.4 | -0.6 | -0.5 | -3.0 | 3.0 | -0.5 | -1.8 | -1.0 | 0.6 | -2.4 | 0.7 | -3.9 | -4.1 | -3.8 | -2.9 | 0.1 | -4.5 | -4.3 | -2.8 | -3.4 | -3.9 | -2.9 | -1.4 | -2.2 | -4.1 | -0.3 | -6.7 | 0.4 | -2.9 | 266.7 | 27.1 | 28.6 | 298.9 | 55.9 | 54.4 | 96.8 | 122.1 | 66.1 | 103.5 | 28.6 | 206.2 | 67.6 | 14.9 | 19.6 | 100.3 | 61.4 | 649.6 | 68.7 | 73.3 | 74.4 | 62.8 | 98.6 | 48.3 | 41.9 | 40.4 | 92.0 | 62.5 | 38.9 | 146.4 | 43.4 | 56.0 | 209.4 | 102.7 |
[back to top]
Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=58, 56, 57, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=49, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 24.8 | 46.0 | 65.6 | 103.4 | 135.5 | 149.0 | 143.4 | 166.4 | 178.2 | 197.4 | 185.2 | 221.5 | 262.5 | 263.8 | 257.1 | 279.4 | 281.7 |
[back to top]
Change From Baseline in CD4+ Cell Count Over Time by Visit
CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=58, 56, 57, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=49, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=46, 46, 52, 41 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 46, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=35, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=32, 39, 47, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 46, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=30, 37, 44, 0 | Week 312; n=30, 34, 43, 0 | Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 92.6 | 136.4 | 129.9 | 140.5 | 159.3 | 165.2 | 172.5 | 186.4 | 205.0 | 191.4 | 192.0 | 203.6 | 235.1 | 217.7 | 232.0 | 261.5 | 269.4 | 296.2 | 266.1 | 297.1 | 330.7 | 334.5 | 338.1 | 338.0 | 300.8 | 369.5 | 397.0 | 331.8 | 356.5 | 400.3 | 344.4 | 398.3 | 411.0 | 437.7 | 335.0 | 402.0 |
,GSK1265744 30 mg | 79.5 | 76.9 | 117.8 | 140.8 | 142.2 | 153.8 | 180.9 | 177.7 | 188.1 | 205.2 | 213.0 | 212.8 | 241.6 | 269.4 | 201.4 | 287.0 | 267.5 | 304.3 | 279.3 | 305.2 | 308.9 | 319.2 | 332.4 | 348.6 | 351.0 | 332.9 | 373.4 | 366.5 | 395.9 | 343.7 | 365.0 | 350.3 | 383.5 | 404.4 | 433.0 | 276.0 |
,GSK1265744 60 mg | 91.7 | 88.2 | 90.5 | 145.2 | 148.3 | 182.6 | 204.0 | 194.7 | 193.3 | 209.9 | 265.0 | 212.3 | 259.0 | 266.1 | 254.0 | 278.1 | 286.2 | 288.4 | 307.2 | 313.2 | 322.4 | 320.4 | 361.3 | 384.2 | 342.3 | 340.0 | 357.8 | 383.7 | 408.4 | 383.1 | 391.8 | 362.2 | 337.1 | 353.5 | 407.0 | 272.0 |
[back to top]
Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine; Week 2; n=58, 56, 58, 58 | Creatinine; Week 4; n=58, 57, 59, 57 | Creatinine; Week 8; n=58, 55, 57, 54 | Creatinine; Week 12; n=58, 53, 57, 51 | Creatinine; Week 16; n=57, 54, 57, 52 | Creatinine; Week 20; n=56, 54, 55, 49 | Creatinine; Week 24; n=56, 53, 56, 47 | Creatinine; Week 26; n=48, 50, 53, 45 | Creatinine; Week 28; n=51, 52, 52, 45 | Creatinine; Week 32; n=52, 53, 55, 45 | Creatinine; Week 36; n=52, 52, 55, 45 | Creatinine; Week 40; n=52, 53, 55, 44 | Creatinine; Week 48; n=51, 53, 54, 44 | Creatinine; Week 60; n=48, 47, 53, 44 | Creatinine; Week 72; n=47, 47, 52, 42 | Creatinine; Week 84; n=46, 48, 52, 42 | Creatinine; Week 96; n=45, 48, 52, 40 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | T. Bilirubin; Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 0.65 | -0.32 | -0.92 | -1.42 | -2.92 | -3.26 | -2.03 | -2.67 | -3.42 | -3.50 | -3.26 | -2.83 | -2.73 | -3.87 | -4.48 | -2.48 | -2.28 | -3.0 | -3.4 | -3.4 | -2.4 | -2.4 | -2.6 | -2.9 | -2.7 | -2.8 | -2.6 | -2.7 | -2.9 | -2.6 | -2.2 | -2.7 | -2.6 | -2.5 |
[back to top]
Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit
Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine; Week 2; n=58, 56, 58, 58 | Creatinine; Week 4; n=58, 57, 59, 57 | Creatinine; Week 8; n=58, 55, 57, 54 | Creatinine; Week 12; n=58, 53, 57, 51 | Creatinine; Week 16; n=57, 54, 57, 52 | Creatinine; Week 20; n=56, 54, 55, 49 | Creatinine; Week 24; n=56, 53, 56, 47 | Creatinine; Week 26; n=48, 50, 53, 45 | Creatinine; Week 28; n=51, 52, 52, 45 | Creatinine; Week 32; n=52, 53, 55, 45 | Creatinine; Week 36; n=52, 52, 55, 45 | Creatinine; Week 40; n=52, 53, 55, 44 | Creatinine; Week 48; n=51, 53, 54, 44 | Creatinine; Week 60; n=48, 47, 53, 44 | Creatinine; Week 72; n=47, 47, 52, 42 | Creatinine; Week 84; n=46, 48, 52, 42 | Creatinine; Week 96; n=45, 48, 52, 40 | Creatinine; Week 108; n=43, 46, 48, 0 | Creatinine; Week 120; n=40, 45, 48, 0 | Creatinine; Week 132; n=40, 46, 49, 0 | Creatinine; Week 144; n=37, 45, 47, 0 | Creatinine; Week 156; n=37, 42, 49, 0 | Creatinine; Week 168; n=35, 43, 47, 0 | Creatinine; Week 180; n=36, 41, 47, 0 | Creatinine; Week 192; n=36, 39, 47, 0 | Creatinine; Week 204; n=34, 39, 47, 0 | Creatinine; Week 216; n=33, 39, 46, 0 | Creatinine; Week 228; n=32, 39, 47, 0 | Creatinine; Week 240; n=30, 39, 46, 0 | Creatinine; Week 252; n=31, 38, 46, 0 | Creatinine; Week 264; n=32, 38, 47, 0 | Creatinine; Week 276; n=31, 38, 45, 0 | Creatinine; Week 288; n=31, 38, 45, 0 | Creatinine; Week 300; n=30, 37, 44, 0 | Creatinine; Week 312; n=31, 34, 43, 0 | Creatinine; Week 324; n=3, 4, 3, 0 | T. Bilirubin; Week 2; n=58, 56, 58, 58 | T. Bilirubin; Week 4; n=58, 57, 59, 57 | T. Bilirubin; Week 8; n=58, 55, 57, 54 | T. Bilirubin; Week 12; n=58, 53, 57, 51 | T. Bilirubin; Week 16; n=57, 54, 57, 52 | T. Bilirubin; Week 20; n=56, 54, 55, 49 | T. Bilirubin; Week 24; n=56, 53, 56, 47 | T. Bilirubin; Week 26; n=48, 50, 53, 45 | T. Bilirubin; Week 28; n=51, 52, 52, 45 | T. Bilirubin; Week 32; n=52, 53, 55, 45 | T. Bilirubin; Week 36; n=52, 52, 55, 45 | T. Bilirubin; Week 40; n=52, 53, 55, 44 | T. Bilirubin; Week 48; n=51, 53, 54, 44 | T. Bilirubin; Week 60; n=48, 47, 53, 44 | T. Bilirubin; Week 72; n=47, 47, 52, 42 | T. Bilirubin; Week 84; n=46, 48, 52, 42 | T. Bilirubin; Week 96; n=45, 48, 52, 40 | T. Bilirubin; Week 108; n=43, 46, 48, 0 | T. Bilirubin; Week 120; n=40, 45, 48, 0 | T. Bilirubin; Week 132; n=40, 46, 49, 0 | T. Bilirubin; Week 144; n=37, 45, 47, 0 | T. Bilirubin; Week 156; n=37, 42, 49, 0 | T. Bilirubin; Week 168; n=35, 43, 47, 0 | T. Bilirubin; Week 180; n=36, 41, 47, 0 | T. Bilirubin; Week 192; n=36, 39, 47, 0 | T. Bilirubin; Week 204; n=34, 39, 47, 0 | T. Bilirubin; Week 216; n=33, 39, 46, 0 | T. Bilirubin; Week 228; n=32, 39, 47, 0 | T. Bilirubin; Week 240; n=30, 39, 46, 0 | T. Bilirubin; Week 252; n=31, 38, 46, 0 | T. Bilirubin; Week 264; n=32, 38, 47, 0 | T. Bilirubin; Week 276; n=31, 38, 45, 0 | T. Bilirubin; Week 288; n=31, 38, 45, 0 | T. Bilirubin; Week 300; n=30, 37, 44, 0 | T. Bilirubin; Week 312; n=31, 34, 43, 0 | T. Bilirubin; Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | 3.36 | 2.24 | 2.38 | 3.39 | 2.91 | 2.54 | 2.52 | 2.74 | 2.22 | 3.36 | 3.11 | 2.83 | 2.75 | 3.28 | 3.89 | 4.58 | 1.90 | 5.87 | 4.41 | 3.76 | 5.99 | 5.28 | 6.57 | 5.89 | 6.90 | 6.21 | 8.34 | 7.16 | 8.48 | 6.96 | 5.97 | 7.89 | 8.81 | 10.49 | 7.98 | 15.90 | 0.0 | 0.1 | 0.0 | 0.4 | 0.4 | -0.1 | 0.5 | 1.1 | 1.1 | 0.7 | 1.2 | 1.6 | 0.9 | 1.9 | 1.5 | 2.3 | 1.0 | 0.7 | 0.9 | 1.0 | 0.7 | 1.6 | 1.1 | 1.1 | 0.7 | 1.1 | 0.5 | 1.6 | 1.2 | 1.4 | 0.4 | 0.7 | 0.5 | 1.1 | 1.4 | 5.3 |
,GSK1265744 30 mg | 2.58 | 2.50 | 2.06 | 1.59 | 1.10 | 0.85 | 2.44 | 1.80 | 2.80 | 1.69 | 3.41 | 2.36 | 2.18 | 2.30 | 4.71 | 3.80 | 5.34 | 5.18 | 4.15 | 4.02 | 5.80 | 6.36 | 5.62 | 5.08 | 7.91 | 6.46 | 9.31 | 7.19 | 7.33 | 7.52 | 7.10 | 5.84 | 7.84 | 9.16 | 7.86 | 9.75 | -0.3 | -0.3 | -0.5 | -0.9 | -1.2 | -0.7 | 0.2 | 0.5 | 0.7 | 0.2 | 0.6 | 1.7 | 0.1 | 0.0 | 0.1 | 0.1 | 0.0 | 1.4 | 1.1 | 2.0 | 1.1 | 1.0 | 0.8 | 0.0 | 0.3 | 0.7 | 0.8 | 0.5 | 0.9 | 2.0 | 2.9 | 2.8 | 1.9 | 1.7 | 1.1 | 5.5 |
,GSK1265744 60 mg | 4.15 | 4.08 | 3.44 | 3.79 | 2.09 | 5.29 | 4.45 | 6.03 | 5.01 | 5.00 | 6.00 | 4.76 | 4.47 | 4.46 | 6.59 | 6.53 | 7.76 | 7.26 | 6.78 | 4.99 | 5.07 | 5.16 | 6.82 | 5.91 | 5.90 | 5.16 | 7.42 | 6.61 | 7.08 | 7.64 | 6.99 | 6.19 | 6.20 | 8.19 | 7.10 | 5.03 | -0.4 | -0.8 | -0.6 | -0.5 | -0.2 | -0.4 | -0.7 | 1.0 | 0.5 | 0.9 | 1.4 | 1.5 | -0.3 | 0.9 | 0.6 | 1.2 | 1.7 | 0.8 | 1.3 | 1.1 | 0.4 | 1.0 | 1.4 | 1.0 | 0.9 | 0.6 | 0.3 | -0.3 | -0.1 | 0.2 | -0.1 | 0.9 | 0.0 | 0.9 | 0.8 | 0.7 |
[back to top]
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 26; n=0, 1, 0, 0 | Week 40; n=0, 1, 0, 0 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 | Week 204; n=0, 1, 0, 0 | Week 252; n=0, 1, 0, 0 |
---|
GSK1265744 30 mg | -10.0 | -3.7 | -1.0 | 0.2 | -6.4 | -7.0 | -95.0 | -1.1 | -2.4 | -23.0 | 0.0 |
[back to top]
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 96; n=45, 48, 52, 40 | Week 264; n=0, 0, 1, 0 |
---|
GSK1265744 60 mg | -4.9 | 7.0 | -2.7 | -5.8 | -4.5 | -9.0 | -143.0 |
[back to top]
Change From Baseline in Estimated Creatinine Clearance Over Time by Visit
Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264
Intervention | Milliliters per minute (Mean) |
---|
| Week 2; n=1, 1, 0, 3 | Week 4; n=58, 57, 59, 57 | Week 8; n=2, 1, 1, 1 | Week 16; n=55, 53, 56, 49 | Week 20; n=2, 0, 0, 1 | Week 24; n=52, 53, 55, 46 | Week 48; n=51, 50, 54, 44 | Week 60; n=0, 0, 0, 1 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | -0.7 | -0.1 | 0.0 | 3.4 | 4.0 | 4.8 | 0.4 | 16.0 | 5.1 |
[back to top]
Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Grams per liter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=57, 57, 59, 57 | Week 8; n=58, 56, 56, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 55, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=50, 52, 52, 45 | Week 32; n=51, 53, 55, 45 | Week 36; n=52, 53, 55, 44 | Week 40; n=51, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 52, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 51, 42 | Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 0.7 | 0.7 | 2.0 | 2.8 | 1.1 | 0.8 | 1.9 | 2.2 | 0.1 | 0.6 | -0.8 | -0.2 | 0.0 | 2.3 | 2.4 | 1.7 | 1.9 |
[back to top]
Change From Baseline in Hemoglobin Level Over Time by Visit
Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Grams per liter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=57, 57, 59, 57 | Week 8; n=58, 56, 56, 55 | Week 12; n=58, 53, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 55, 49 | Week 24; n=56, 53, 56, 47 | Week 26; n=48, 50, 53, 45 | Week 28; n=50, 52, 52, 45 | Week 32; n=51, 53, 55, 45 | Week 36; n=52, 53, 55, 44 | Week 40; n=51, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 47, 52, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 51, 42 | Week 96; n=46, 46, 52, 41 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 46, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=35, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=32, 39, 44, 0 | Week 228; n=31, 39, 47, 0 | Week 240; n=32, 39, 47, 0 | Week 252; n=31, 36, 45, 0 | Week 264; n=32, 38, 46, 0 | Week 276; n=31, 38, 46, 0 | Week 288; n=30, 38, 44, 0 | Week 300; n=30, 37, 43, 0 | Week 312; n=31, 33, 42, 0 | Week 324; n=3, 4, 2, 0 |
---|
GSK1265744 10 mg | 0.1 | -0.2 | 2.7 | 2.0 | 1.1 | 2.1 | 2.6 | 1.8 | 1.7 | 1.6 | 0.3 | 0.5 | 1.2 | 2.6 | 1.8 | 3.3 | 2.7 | 4.0 | 4.2 | 3.5 | 4.0 | 4.0 | 6.3 | 5.5 | 3.3 | 4.5 | 4.7 | 5.1 | 6.2 | 6.2 | 6.3 | 6.6 | 7.3 | 4.6 | 7.0 | 4.3 |
,GSK1265744 30 mg | 0.0 | 0.5 | 4.8 | 3.9 | 3.5 | 3.8 | 4.8 | 3.4 | 4.0 | 3.1 | 2.9 | 2.2 | 2.7 | 4.7 | 4.5 | 4.0 | 3.3 | 3.4 | 4.7 | 3.0 | 2.6 | 5.1 | 6.0 | 4.0 | 3.5 | 4.7 | 4.1 | 4.8 | 5.8 | 6.4 | 6.0 | 5.5 | 6.8 | 5.1 | 6.1 | 10.0 |
,GSK1265744 60 mg | -0.7 | 0.6 | 2.0 | 2.6 | 2.3 | 3.1 | 3.6 | 2.5 | 1.5 | 3.5 | 2.7 | 2.1 | -0.5 | 2.2 | 2.4 | 3.0 | 3.6 | 3.0 | 2.1 | 2.5 | 2.3 | 2.7 | 4.8 | 2.7 | 3.0 | 3.2 | 3.4 | 3.1 | 2.1 | 5.8 | 5.5 | 5.4 | 6.9 | 5.5 | 8.0 | 20.5 |
[back to top]
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | -1.875 | -2.092 | -2.344 | -2.533 | -2.602 | -2.666 | -2.694 | -2.733 | -2.714 | -2.672 | -2.679 | -2.679 | -2.676 | -2.615 | -2.738 | -2.739 | -2.731 |
[back to top]
Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit
Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Log10 copies per milliliter (Mean) |
---|
| Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 | Week 108; n=43, 46, 49, 0 | Week 120; n=41, 46, 49, 0 | Week 132; n=40, 46, 49, 0 | Week 144; n=37, 45, 47, 0 | Week 156; n=37, 42, 49, 0 | Week 168; n=35, 43, 47, 0 | Week 180; n=36, 41, 47, 0 | Week 192; n=36, 40, 47, 0 | Week 204; n=34, 39, 47, 0 | Week 216; n=33, 39, 47, 0 | Week 228; n=32, 39, 47, 0 | Week 240; n=31, 39, 45, 0 | Week 252; n=31, 38, 47, 0 | Week 264; n=32, 38, 47, 0 | Week 276; n=31, 38, 45, 0 | Week 288; n=30, 38, 45, 0 | Week 300; n=31, 37, 44, 0 | Week 312; n=31, 33, 43, 0 | Week 324; n=3, 4, 3, 0 |
---|
GSK1265744 10 mg | -2.534 | -2.731 | -2.733 | -2.793 | -2.823 | -2.823 | -2.831 | -2.788 | -2.784 | -2.763 | -2.768 | -2.760 | -2.682 | -2.729 | -2.745 | -2.722 | -2.670 | -2.723 | -2.712 | -2.705 | -2.690 | -2.737 | -2.680 | -2.747 | -2.671 | -2.750 | -2.787 | -2.770 | -2.798 | -2.787 | -2.780 | -2.786 | -2.768 | -2.776 | -2.780 | -2.488 |
,GSK1265744 30 mg | -2.306 | -2.550 | -2.611 | -2.634 | -2.659 | -2.665 | -2.659 | -2.662 | -2.663 | -2.636 | -2.646 | -2.638 | -2.602 | -2.613 | -2.514 | -2.568 | -2.608 | -2.632 | -2.650 | -2.610 | -2.555 | -2.645 | -2.592 | -2.628 | -2.641 | -2.632 | -2.636 | -2.636 | -2.627 | -2.601 | -2.659 | -2.659 | -2.659 | -2.664 | -2.569 | -2.215 |
,GSK1265744 60 mg | -2.504 | -2.718 | -2.741 | -2.790 | -2.815 | -2.834 | -2.830 | -2.792 | -2.791 | -2.781 | -2.792 | -2.790 | -2.799 | -2.787 | -2.783 | -2.782 | -2.778 | -2.743 | -2.717 | -2.743 | -2.703 | -2.716 | -2.700 | -2.767 | -2.667 | -2.718 | -2.718 | -2.726 | -2.736 | -2.758 | -2.734 | -2.764 | -2.775 | -2.730 | -2.789 | -2.438 |
[back to top]
Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Giga cells per liter (Mean) |
---|
| T. neutrophils; Week 2; n=57, 56, 59, 59 | T. neutrophils; Week 4; n=57, 57, 59, 57 | T. neutrophils; Week 8; n=58, 56, 56, 55 | T. neutrophils; Week 12; n=58, 53, 57, 51 | T. neutrophils; Week 16; n=57, 54, 57, 52 | T. neutrophils; Week 20; n=56, 54, 55, 49 | T. neutrophils; Week 24; n=56, 53, 56, 47 | T. neutrophils; Week 26; n=48, 50, 53, 45 | T. neutrophils; Week 28; n=50, 52, 52, 45 | T. neutrophils; Week 32; n=51, 53, 55, 45 | T. neutrophils; Week 36; n=52, 53, 55, 44 | T. neutrophils; Week 40; n=51, 53, 55, 45 | T. neutrophils; Week 48; n=51, 53, 54, 44 | T. neutrophils; Week 60; n=48, 47, 52, 44 | T. neutrophils; Week 72; n=47, 48, 52, 42 | T. neutrophils; Week 84; n=46, 48, 51, 42 | T. neutrophils; Week 96; n=46, 46, 52, 41 | T. neutrophils; Week 108; n=43, 46, 49, 0 | T. neutrophils; Week 120; n=41, 46, 49, 0 | T. neutrophils; Week 132; n=40, 46, 49, 0 | T. neutrophils; Week 144; n=37, 45, 46, 0 | T. neutrophils; Week 156; n=37, 42, 49, 0 | T. neutrophils; Week 168; n=35, 43, 47, 0 | T. neutrophils; Week 180; n=36, 41, 47, 0 | T. neutrophils; Week 192; n=35, 40, 47, 0 | T. neutrophils; Week 204; n=34, 39, 47, 0 | T. neutrophils; Week 216; n=32, 39, 43, 0 | T. neutrophils; Week 228; n=30, 39, 47, 0 | T. neutrophils; Week 240; n=32, 39, 47, 0 | T. neutrophils; Week 252; n=31, 36, 45, 0 | T. neutrophils; Week 264; n=32, 38, 46, 0 | T. neutrophils; Week 276; n=31, 38, 45, 0 | T. neutrophils; Week 288; n=30, 38, 44, 0 | T. neutrophils; Week 300; n=30, 37, 43, 0 | T. neutrophils; Week 312; n=31, 33, 41, 0 | T. neutrophils; Week 324; n=3, 4, 2, 0 | Platelet count; Week 2; n=57, 56, 59, 59 | Platelet count; Week 4; n=57, 57, 59, 57 | Platelet count; Week 8; n=58, 56, 56, 55 | Platelet count; Week 12; n=58, 53, 57, 51 | Platelet count; Week 16; n=57, 54, 57, 52 | Platelet count; Week 20; n=56, 54, 55, 49 | Platelet count; Week 24; n=56, 53, 56, 47 | Platelet count; Week 26; n=48, 50, 53, 45 | Platelet count; Week 28; n=50, 52, 52, 45 | Platelet count; Week 32; n=51, 52, 55, 45 | Platelet count; Week 36; n=52, 53, 55, 44 | Platelet count; Week 40; n=51, 53, 54, 45 | Platelet count; Week 48; n=51, 52, 53, 44 | Platelet count; Week 60; n=48, 47, 51, 44 | Platelet count; Week 72; n=47, 48, 52, 42 | Platelet count; Week 84; n=46, 48, 51, 42 | Platelet count; Week 96; n=46, 45, 51, 41 | Platelet count; Week 108; n=43, 46, 49, 0 | Platelet count; Week 120; n=41, 46, 49, 0 | Platelet count; Week 132; n=40, 46, 48, 0 | Platelet count; Week 144; n=37, 45, 44, 0 | Platelet count; Week 156; n=37, 42, 47, 0 | Platelet count; Week 168; n=35, 43, 46, 0 | Platelet count; Week 180; n=36, 41, 46, 0 | Platelet count; Week 192; n=35, 40, 46, 0 | Platelet count; Week 204; n=34, 39, 45, 0 | Platelet count; Week 216; n=32, 39, 44, 0 | Platelet count; Week 228; n=31, 39, 46, 0 | Platelet count; Week 240; n=32, 39, 47, 0 | Platelet count; Week 252; n=31, 36, 44, 0 | Platelet count; Week 264; n=32, 38, 45, 0 | Platelet count; Week 276; n=31, 38, 45, 0 | Platelet count; Week 288; n=30, 38, 43, 0 | Platelet count; Week 300; n=30, 37, 40, 0 | Platelet count; Week 312; n=31, 33, 41, 0 | Platelet count; Week 324; n=3, 4, 2, 0 | WBC count; Week 2; n=57, 56, 59, 59 | WBC count; Week 4; n=57, 57, 59, 57 | WBC count; Week 8; n=58, 56, 56, 55 | WBC; Week 12; n=58, 53, 57, 51 | WBC count; Week 16; n=57, 54, 57, 52 | WBC count; Week 20; n=56, 54, 55, 49 | WBC count; Week 24; n=56, 53, 56, 47 | WBC count; Week 26; n=48, 50, 53, 45 | WBC count; Week 28; n=50, 52, 52, 45 | WBC count; Week 32; n=51, 53, 55, 45 | WBC count; Week 36; n=52, 53, 55, 44 | WBC count; Week 40; n=51, 53, 55, 45 | WBC count; Week 48; n=51, 53, 54, 44 | WBC count; Week 60; n=48, 47, 52, 44 | WBC count; Week 72; n=47, 48, 52, 42 | WBC count; Week 84; n=46, 48, 51, 42 | WBC count; Week 96; n=46, 46, 52, 41 | WBC count; Week 108; n=43, 46, 49, 0 | WBC count; Week 120; n=41, 46, 49, 0 | WBC count; Week 132; n=40, 46, 49, 0 | WBC count; Week 144; n=37, 45, 46, 0 | WBC count; Week 156; n=37, 42, 49, 0 | WBC count; Week 168; n=35, 43, 47, 0 | WBC count; Week 180; n=36, 41, 47, 0 | WBC count; Week 192; n=35, 40, 47, 0 | WBC count; Week 204; n=34, 39, 47, 0 | WBC count; Week 216; n=32, 39, 43, 0 | WBC count; Week 228; n=31, 39, 47, 0 | WBC count; Week 240; n=32, 39, 47, 0 | WBC count; Week 252; n=31, 36, 45, 0 | WBC count; Week 264; n=32, 38, 46, 0 | WBC count; Week 276; n=31, 38, 45, 0 | WBC count; Week 288; n=30, 38, 44, 0 | WBC count; Week 300; n=30, 37, 43, 0 | WBC count; Week 312; n=31, 33, 41, 0 | WBC count; Week 324; n=3, 4, 2, 0 |
---|
GSK1265744 10 mg | 0.042 | 0.038 | 0.251 | 0.138 | 0.388 | 0.270 | 0.462 | 0.120 | 0.496 | 0.071 | 0.420 | 0.430 | 0.386 | 0.374 | 0.383 | 0.410 | 0.631 | 0.623 | 0.372 | 0.777 | 0.672 | 0.762 | 0.588 | 0.769 | 0.490 | 0.618 | 0.543 | 0.780 | 0.508 | 0.268 | 0.475 | 0.400 | 0.456 | 0.139 | 0.243 | 0.860 | 11.0 | 9.9 | 10.3 | 13.7 | 16.5 | 17.2 | 12.0 | 8.3 | 6.6 | 7.7 | 5.2 | 11.1 | 12.5 | 20.9 | 23.7 | 13.6 | 25.9 | 24.5 | 23.8 | 16.8 | 27.1 | 26.6 | 34.9 | 28.4 | 34.7 | 33.9 | 28.1 | 28.7 | 27.2 | 15.9 | 27.9 | 48.4 | 44.1 | 28.5 | 27.3 | 31.7 | 0.19 | 0.16 | 0.37 | 0.32 | 0.45 | 0.36 | 0.47 | 0.19 | 0.67 | 0.25 | 0.56 | 0.57 | 0.43 | 0.60 | 0.63 | 0.71 | 0.95 | 0.89 | 0.59 | 0.92 | 0.91 | 1.05 | 0.97 | 1.07 | 0.61 | 0.98 | 0.88 | 0.98 | 0.79 | 0.66 | 0.62 | 0.92 | 0.92 | 0.58 | 0.57 | 1.97 |
,GSK1265744 30 mg | -0.084 | -0.083 | -0.066 | 0.040 | -0.156 | 0.032 | 0.109 | 0.052 | 0.213 | 0.149 | 0.029 | 0.178 | 0.245 | 0.458 | 0.274 | 0.528 | 0.698 | 0.570 | 0.650 | 0.405 | 0.468 | 0.418 | 0.534 | 0.405 | 0.594 | 0.648 | 0.588 | 0.789 | 0.813 | 0.761 | 0.761 | 0.627 | 0.673 | 0.455 | 0.417 | 0.315 | 16.6 | 20.1 | 25.9 | 14.6 | 11.3 | 14.5 | 18.4 | 11.2 | 15.8 | 11.6 | 10.8 | 8.9 | 20.0 | 18.7 | 22.8 | 17.2 | 20.8 | 24.6 | 26.9 | 21.0 | 23.2 | 30.6 | 36.4 | 27.6 | 24.6 | 26.4 | 25.2 | 27.1 | 26.2 | 15.4 | 23.2 | 34.5 | 35.5 | 26.8 | 30.9 | 8.3 | 0.13 | 0.02 | 0.15 | 0.28 | 0.02 | 0.23 | 0.34 | 0.26 | 0.42 | 0.45 | 0.30 | 0.42 | 0.53 | 0.76 | 0.56 | 0.96 | 1.01 | 0.90 | 1.01 | 0.71 | 0.82 | 0.75 | 0.97 | 0.69 | 0.89 | 0.95 | 1.01 | 1.13 | 1.15 | 1.10 | 1.21 | 1.04 | 1.13 | 0.77 | 0.70 | 0.53 |
,GSK1265744 60 mg | 0.104 | 0.155 | 0.341 | 0.359 | 0.203 | 0.525 | 0.406 | 0.375 | 0.502 | 0.692 | 0.535 | 0.575 | 0.534 | 0.711 | 0.666 | 1.006 | 0.997 | 1.006 | 0.769 | 0.671 | 0.831 | 1.095 | 1.011 | 0.840 | 0.722 | 0.821 | 0.914 | 0.819 | 1.083 | 0.812 | 1.176 | 1.106 | 0.913 | 0.699 | 0.564 | 0.960 | 14.3 | 14.1 | 18.4 | 17.7 | 17.9 | 13.7 | 19.3 | 10.3 | 17.8 | 15.4 | 11.8 | 7.8 | 17.6 | 26.6 | 22.7 | 21.1 | 21.7 | 33.1 | 20.4 | 32.2 | 33.5 | 41.2 | 40.0 | 45.4 | 27.9 | 37.6 | 33.5 | 29.1 | 27.4 | 30.8 | 32.8 | 45.8 | 46.7 | 45.4 | 35.3 | 2.0 | 0.31 | 0.30 | 0.48 | 0.73 | 0.36 | 0.77 | 0.64 | 0.66 | 0.69 | 0.93 | 0.92 | 0.81 | 0.78 | 1.04 | 1.09 | 1.43 | 1.38 | 1.35 | 1.16 | 1.02 | 1.22 | 1.64 | 1.58 | 1.33 | 1.11 | 1.24 | 1.37 | 1.31 | 1.53 | 1.17 | 1.66 | 1.57 | 1.32 | 1.02 | 0.95 | -0.05 |
[back to top]
Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit
Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value. (NCT01641809)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Giga cells per liter (Mean) |
---|
| T. neutrophils; Week 2; n=57, 56, 59, 59 | T. neutrophils; Week 4; n=57, 57, 59, 57 | T. neutrophils; Week 8; n=58, 56, 56, 55 | T. neutrophils; Week 12; n=58, 53, 57, 51 | T. neutrophils; Week 16; n=57, 54, 57, 52 | T. neutrophils; Week 20; n=56, 54, 55, 49 | T. neutrophils; Week 24; n=56, 53, 56, 47 | T. neutrophils; Week 26; n=48, 50, 53, 45 | T. neutrophils; Week 28; n=50, 52, 52, 45 | T. neutrophils; Week 32; n=51, 53, 55, 45 | T. neutrophils; Week 36; n=52, 53, 55, 44 | T. neutrophils; Week 40; n=51, 53, 55, 45 | T. neutrophils; Week 48; n=51, 53, 54, 44 | T. neutrophils; Week 60; n=48, 47, 52, 44 | T. neutrophils; Week 72; n=47, 48, 52, 42 | T. neutrophils; Week 84; n=46, 48, 51, 42 | T. neutrophils; Week 96; n=46, 46, 52, 41 | Platelet count; Week 2; n=57, 56, 59, 59 | Platelet count; Week 4; n=57, 57, 59, 57 | Platelet count; Week 8; n=58, 56, 56, 55 | Platelet count; Week 12; n=58, 53, 57, 51 | Platelet count; Week 16; n=57, 54, 57, 52 | Platelet count; Week 20; n=56, 54, 55, 49 | Platelet count; Week 24; n=56, 53, 56, 47 | Platelet count; Week 26; n=48, 50, 53, 45 | Platelet count; Week 28; n=50, 52, 52, 45 | Platelet count; Week 32; n=51, 52, 55, 45 | Platelet count; Week 36; n=52, 53, 55, 44 | Platelet count; Week 40; n=51, 53, 54, 45 | Platelet count; Week 48; n=51, 52, 53, 44 | Platelet count; Week 60; n=48, 47, 51, 44 | Platelet count; Week 72; n=47, 48, 52, 42 | Platelet count; Week 84; n=46, 48, 51, 42 | Platelet count; Week 96; n=46, 45, 51, 41 | WBC count; Week 2; n=57, 56, 59, 59 | WBC count; Week 4; n=57, 57, 59, 57 | WBC count; Week 8; n=58, 56, 56, 55 | WBC; Week 12; n=58, 53, 57, 51 | WBC count; Week 16; n=57, 54, 57, 52 | WBC count; Week 20; n=56, 54, 55, 49 | WBC count; Week 24; n=56, 53, 56, 47 | WBC count; Week 26; n=48, 50, 53, 45 | WBC count; Week 28; n=50, 52, 52, 45 | WBC count; Week 32; n=51, 53, 55, 45 | WBC count; Week 36; n=52, 53, 55, 44 | WBC count; Week 40; n=51, 53, 55, 45 | WBC count; Week 48; n=51, 53, 54, 44 | WBC count; Week 60; n=48, 47, 52, 44 | WBC count; Week 72; n=47, 48, 52, 42 | WBC count; Week 84; n=46, 48, 51, 42 | WBC count; Week 96; n=46, 46, 52, 41 |
---|
Efavirenz 600 mg | 0.716 | 0.375 | 0.273 | 0.525 | 0.367 | 0.740 | 0.637 | 0.449 | 0.446 | 0.717 | 0.414 | 0.730 | 0.665 | 0.800 | 0.892 | 0.790 | 0.831 | 17.1 | 15.6 | 10.3 | 11.2 | 9.3 | 17.1 | 23.9 | 17.5 | 17.2 | 13.8 | 12.3 | 18.9 | 20.6 | 30.8 | 28.3 | 18.9 | 17.5 | 0.69 | 0.29 | 0.27 | 0.54 | 0.36 | 0.78 | 0.55 | 0.35 | 0.39 | 0.71 | 0.36 | 0.75 | 0.73 | 0.95 | 1.02 | 0.95 | 0.92 |
[back to top]
Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Participants (Count of Participants) |
---|
| Baseline; n=57, 55, 56, 52 | Week 4; n=54, 52, 53, 50 | Week 8; n=53, 50, 56, 48 | Week 12; n=55, 48, 53, 48 | Week 16; n=53, 51, 53, 44 | Week 20; n=51, 49, 55, 44 | Week 24; n=51, 46, 51, 43 | Week 28; n=49, 48, 53, 41 | Week 32; n=47, 48, 55, 41 | Week 36; n=46, 48, 50, 41 | Week 40; n=38, 35, 45, 39 | Week 48; n=33, 37, 45, 35 | Week 60; n=38, 38, 40, 37 | Week 72; n=35, 37, 44, 32 | Week 84; n=36, 39, 42, 33 |
---|
Efavirenz 600 mg | 48 | 44 | 47 | 43 | 42 | 41 | 39 | 35 | 37 | 36 | 34 | 33 | 35 | 27 | 29 |
[back to top]
Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Participants (Count of Participants) |
---|
| Baseline; n=57, 55, 56, 52 | Week 4; n=54, 52, 53, 50 | Week 8; n=53, 50, 56, 48 | Week 12; n=55, 48, 53, 48 | Week 16; n=53, 51, 53, 44 | Week 20; n=51, 49, 55, 44 | Week 24; n=51, 46, 51, 43 | Week 28; n=49, 48, 53, 41 | Week 32; n=47, 48, 55, 41 | Week 36; n=46, 48, 50, 41 | Week 40; n=38, 35, 45, 39 | Week 48; n=33, 37, 45, 35 | Week 60; n=38, 38, 40, 37 | Week 72; n=35, 37, 44, 32 | Week 84; n=36, 39, 42, 33 | Week 96; n=31, 36, 33, 0 | Week 108; n=23, 23, 29, 0 | Week 120; n=30, 38, 41, 0 | Week 132; n=29, 32, 40, 0 | Week 144; n=33, 34, 43, 0 | Week 156; n=31, 28, 39, 0 | Week 168; n=29, 33, 41, 0 | Week 180; n=26, 29, 39, 0 | Week 192; n=30, 30, 39, 0 | Week 204; n=29, 32, 38, 0 | Week 216; n=29, 30, 37, 0 | Week 228; n=27, 34, 40, 0 | Week 240; n=28, 26, 41, 0 | Week 252; n=23, 26, 33, 0 | Week 264; n=15, 18, 24, 0 | Week 276; n=14, 14, 21, 0 | Week 288; n=12, 14, 18, 0 | Week 300; n=12, 13, 20, 0 |
---|
GSK1265744 60 mg | 55 | 52 | 53 | 46 | 50 | 51 | 48 | 48 | 52 | 48 | 41 | 41 | 37 | 41 | 39 | 30 | 27 | 39 | 35 | 41 | 35 | 35 | 34 | 35 | 33 | 31 | 35 | 35 | 29 | 21 | 18 | 17 | 18 |
[back to top]
Number of Participants With Adherence to Study Treatment
Number of participants with >=90% adherence to study treatment based on pill count is summarized. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312
Intervention | Participants (Count of Participants) |
---|
| Baseline; n=57, 55, 56, 52 | Week 4; n=54, 52, 53, 50 | Week 8; n=53, 50, 56, 48 | Week 12; n=55, 48, 53, 48 | Week 16; n=53, 51, 53, 44 | Week 20; n=51, 49, 55, 44 | Week 24; n=51, 46, 51, 43 | Week 28; n=49, 48, 53, 41 | Week 32; n=47, 48, 55, 41 | Week 36; n=46, 48, 50, 41 | Week 40; n=38, 35, 45, 39 | Week 48; n=33, 37, 45, 35 | Week 60; n=38, 38, 40, 37 | Week 72; n=35, 37, 44, 32 | Week 84; n=36, 39, 42, 33 | Week 96; n=31, 36, 33, 0 | Week 108; n=23, 23, 29, 0 | Week 120; n=30, 38, 41, 0 | Week 132; n=29, 32, 40, 0 | Week 144; n=33, 34, 43, 0 | Week 156; n=31, 28, 39, 0 | Week 168; n=29, 33, 41, 0 | Week 180; n=26, 29, 39, 0 | Week 192; n=30, 30, 39, 0 | Week 204; n=29, 32, 38, 0 | Week 216; n=29, 30, 37, 0 | Week 228; n=27, 34, 40, 0 | Week 240; n=28, 26, 41, 0 | Week 252; n=23, 26, 33, 0 | Week 264; n=15, 18, 24, 0 | Week 276; n=14, 14, 21, 0 | Week 288; n=12, 14, 18, 0 | Week 300; n=12, 13, 20, 0 | Week 312; n=1, 1, 0, 0 |
---|
GSK1265744 10 mg | 53 | 46 | 49 | 44 | 44 | 45 | 47 | 45 | 46 | 40 | 33 | 32 | 37 | 32 | 34 | 25 | 21 | 28 | 28 | 32 | 30 | 29 | 24 | 28 | 27 | 29 | 25 | 28 | 18 | 12 | 13 | 12 | 11 | 1 |
,GSK1265744 30 mg | 51 | 49 | 45 | 40 | 45 | 40 | 41 | 46 | 42 | 43 | 30 | 33 | 35 | 35 | 36 | 32 | 20 | 36 | 30 | 29 | 25 | 24 | 24 | 27 | 26 | 27 | 28 | 22 | 21 | 16 | 13 | 10 | 7 | 1 |
[back to top]
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
Efavirenz 600 mg | 35 | 2 |
,GSK1265744 10 mg | 40 | 5 |
,GSK1265744 30 mg | 50 | 5 |
,GSK1265744 60 mg | 50 | 5 |
[back to top]
Number of Participants With AEs and SAEs Over Time
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
Efavirenz 600 mg | 60 | 4 |
,GSK1265744 10 mg | 57 | 13 |
,GSK1265744 30 mg | 57 | 12 |
,GSK1265744 60 mg | 60 | 11 |
[back to top]
Number of Participants With AEs and SAEs-Induction Phase
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
Efavirenz 600 mg | 59 | 2 |
,GSK1265744 10 mg | 54 | 2 |
,GSK1265744 30 mg | 54 | 0 |
,GSK1265744 60 mg | 55 | 2 |
[back to top]
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| ALT; Grade 1 | ALT; Grade 2 | ALT; Grade 3 | ALT; Grade 4 | Albumin; Grade 1 | Albumin; Grade 2 | Albumin; Grade 3 | Albumin; Grade 4 | ALP; Grade 1 | ALP; Grade 2 | ALP; Grade 3 | ALP; Grade 4 | AST; Grade 1 | AST; Grade 2 | AST; Grade 3 | AST; Grade 4 | CO2/bicarbonate; Grade 1 | CO2/bicarbonate; Grade 2 | CO2/bicarbonate; Grade 3 | CO2/bicarbonate; Grade 4 | Cholesterol; Grade 1 | Cholesterol; Grade 2 | Cholesterol; Grade 3 | Cholesterol; Grade 4 | CK; Grade 1 | CK; Grade 2 | CK; Grade 3 | CK; Grade 4 | Creatinine; Grade 1 | Creatinine; Grade 2 | Creatinine; Grade 3 | Creatinine; Grade 4 | Glucose; Grade 1 | Glucose; Grade 2 | Glucose; Grade 3 | Glucose; Grade 4 | LDL cholesterol; Grade 1 | LDL cholesterol; Grade 2 | LDL cholesterol; Grade 3 | LDL cholesterol; Grade 4 | Lipase; Grade 1 | Lipase; Grade 2 | Lipase; Grade 3 | Lipase; Grade 4 | Inorganic phosphorus; Grade 1 | Inorganic phosphorus; Grade 2 | Inorganic phosphorus; Grade 3 | Inorganic phosphorus; Grade 4 | Potassium; Grade 1 | Potassium; Grade 2 | Potassium; Grade 3 | Potassium; Grade 4 | Sodium; Grade 1 | Sodium; Grade 2 | Sodium; Grade 3 | Sodium; Grade 4 | Total bilirubin; Grade 1 | Total bilirubin; Grade 2 | Total bilirubin; Grade 3 | Total bilirubin; Grade 4 | Triglycerides; Grade 1 | Triglycerides; Grade 2 | Triglycerides; Grade 3 | Triglycerides; Grade 4 |
---|
Efavirenz 600 mg | 8 | 4 | 0 | 1 | 0 | 0 | 0 | 0 | 5 | 0 | 0 | 0 | 7 | 2 | 3 | 2 | 8 | 1 | 0 | 0 | 9 | 10 | 6 | 0 | 5 | 0 | 4 | 5 | 1 | 1 | 0 | 0 | 12 | 6 | 0 | 1 | 8 | 7 | 4 | 0 | 10 | 7 | 1 | 0 | 8 | 9 | 2 | 0 | 4 | 1 | 0 | 0 | 11 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
,GSK1265744 10 mg | 9 | 6 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 7 | 6 | 2 | 2 | 6 | 1 | 0 | 0 | 17 | 7 | 3 | 0 | 9 | 2 | 3 | 7 | 1 | 1 | 0 | 0 | 19 | 14 | 0 | 0 | 14 | 7 | 4 | 0 | 11 | 9 | 5 | 2 | 5 | 11 | 2 | 0 | 14 | 0 | 0 | 0 | 14 | 2 | 0 | 0 | 7 | 2 | 0 | 0 | 0 | 1 | 1 | 0 |
,GSK1265744 30 mg | 12 | 6 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 13 | 8 | 0 | 1 | 14 | 0 | 0 | 0 | 17 | 12 | 0 | 0 | 10 | 4 | 2 | 6 | 1 | 0 | 0 | 0 | 18 | 10 | 0 | 0 | 17 | 11 | 2 | 0 | 9 | 8 | 2 | 0 | 3 | 11 | 1 | 0 | 7 | 0 | 0 | 0 | 12 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 4 | 0 | 0 |
,GSK1265744 60 mg | 19 | 5 | 0 | 2 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 15 | 5 | 4 | 0 | 9 | 0 | 0 | 0 | 19 | 15 | 3 | 0 | 12 | 4 | 4 | 5 | 2 | 0 | 0 | 0 | 21 | 11 | 2 | 0 | 13 | 14 | 7 | 0 | 9 | 11 | 6 | 2 | 10 | 6 | 5 | 0 | 8 | 0 | 0 | 0 | 16 | 0 | 0 | 0 | 8 | 4 | 0 | 0 | 0 | 3 | 3 | 1 |
[back to top]
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Participants (Count of Participants) |
---|
| ALT; Grade 1 | ALT; Grade 2 | ALT; Grade 3 | ALT; Grade 4 | Albumin; Grade 1 | Albumin; Grade 2 | Albumin; Grade 3 | Albumin; Grade 4 | ALP; Grade 1 | ALP; Grade 2 | ALP; Grade 3 | ALP; Grade 4 | AST; Grade 1 | AST; Grade 2 | AST; Grade 3 | AST; Grade 4 | CO2/bicarbonate; Grade 1 | CO2/bicarbonate; Grade 2 | CO2/bicarbonate; Grade 3 | CO2/bicarbonate; Grade 4 | Cholesterol; Grade 1 | Cholesterol; Grade 2 | Cholesterol; Grade 3 | Cholesterol; Grade 4 | CK; Grade 1 | CK; Grade 2 | CK; Grade 3 | CK; Grade 4 | Creatinine; Grade 1 | Creatinine; Grade 2 | Creatinine; Grade 3 | Creatinine; Grade 4 | Glucose; Grade 1 | Glucose; Grade 2 | Glucose; Grade 3 | Glucose; Grade 4 | LDL cholesterol; Grade 1 | LDL cholesterol; Grade 2 | LDL cholesterol; Grade 3 | LDL cholesterol; Grade 4 | Lipase; Grade 1 | Lipase; Grade 2 | Lipase; Grade 3 | Lipase; Grade 4 | Inorganic phosphorus; Grade 1 | Inorganic phosphorus; Grade 2 | Inorganic phosphorus; Grade 3 | Inorganic phosphorus; Grade 4 | Potassium; Grade 1 | Potassium; Grade 2 | Potassium; Grade 3 | Potassium; Grade 4 | Sodium; Grade 1 | Sodium; Grade 2 | Sodium; Grade 3 | Sodium; Grade 4 | Total bilirubin; Grade 1 | Total bilirubin; Grade 2 | Total bilirubin; Grade 3 | Total bilirubin; Grade 4 | Triglycerides; Grade 1 | Triglycerides; Grade 2 | Triglycerides; Grade 3 | Triglycerides; Grade 4 |
---|
Efavirenz 600 mg | 6 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 5 | 2 | 3 | 2 | 8 | 1 | 0 | 0 | 9 | 10 | 4 | 0 | 5 | 0 | 3 | 5 | 1 | 0 | 0 | 0 | 11 | 5 | 0 | 0 | 8 | 6 | 4 | 0 | 9 | 7 | 0 | 0 | 7 | 9 | 2 | 0 | 4 | 1 | 0 | 0 | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
,GSK1265744 10 mg | 9 | 6 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 5 | 5 | 2 | 2 | 6 | 1 | 0 | 0 | 17 | 6 | 3 | 0 | 8 | 2 | 3 | 6 | 1 | 1 | 0 | 0 | 17 | 14 | 0 | 0 | 14 | 6 | 4 | 0 | 9 | 9 | 5 | 2 | 5 | 10 | 2 | 0 | 12 | 0 | 0 | 0 | 14 | 2 | 0 | 0 | 7 | 2 | 0 | 0 | 0 | 1 | 1 | 0 |
,GSK1265744 30 mg | 12 | 6 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 13 | 8 | 0 | 1 | 14 | 0 | 0 | 0 | 17 | 12 | 0 | 0 | 9 | 4 | 2 | 6 | 1 | 0 | 0 | 0 | 17 | 10 | 0 | 0 | 16 | 11 | 2 | 0 | 9 | 8 | 1 | 0 | 3 | 11 | 1 | 0 | 7 | 0 | 0 | 0 | 12 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 4 | 0 | 0 |
,GSK1265744 60 mg | 17 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 13 | 5 | 2 | 0 | 9 | 0 | 0 | 0 | 19 | 15 | 3 | 0 | 11 | 4 | 4 | 5 | 2 | 0 | 0 | 0 | 20 | 11 | 2 | 0 | 13 | 14 | 7 | 0 | 8 | 11 | 6 | 2 | 9 | 5 | 5 | 0 | 8 | 0 | 0 | 0 | 16 | 0 | 0 | 0 | 8 | 4 | 0 | 0 | 0 | 3 | 3 | 1 |
[back to top]
Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase
Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| ALT; Grade 1 | ALT; Grade 2 | ALT; Grade 3 | ALT; Grade 4 | Albumin; Grade 1 | Albumin; Grade 2 | Albumin; Grade 3 | Albumin; Grade 4 | ALP; Grade 1 | ALP; Grade 2 | ALP; Grade 3 | ALP; Grade 4 | AST; Grade 1 | AST; Grade 2 | AST; Grade 3 | AST; Grade 4 | CO2/bicarbonate; Grade 1 | CO2/bicarbonate; Grade 2 | CO2/bicarbonate; Grade 3 | CO2/bicarbonate; Grade 4 | Chloride; Grade 1 | Chloride; Grade 2 | Chloride; Grade 3 | Chloride; Grade 4 | Cholesterol; Grade 1 | Cholesterol; Grade 2 | Cholesterol; Grade 3 | Cholesterol; Grade 4 | CK; Grade 1 | CK; Grade 2 | CK; Grade 3 | CK; Grade 4 | Creatinine; Grade 1 | Creatinine; Grade 2 | Creatinine; Grade 3 | Creatinine; Grade 4 | Glucose; Grade 1 | Glucose; Grade 2 | Glucose; Grade 3 | Glucose; Grade 4 | HDL cholesterol; Grade 1 | HDL cholesterol; Grade 2 | HDL cholesterol; Grade 3 | HDL cholesterol; Grade 4 | LDL cholesterol; Grade 1 | LDL cholesterol; Grade 2 | LDL cholesterol; Grade 3 | LDL cholesterol; Grade 4 | Lipase; Grade 1 | Lipase; Grade 2 | Lipase; Grade 3 | Lipase; Grade 4 | Inorganic phosphorus; Grade 1 | Inorganic phosphorus; Grade 2 | Inorganic phosphorus; Grade 3 | Inorganic phosphorus; Grade 4 | Potassium; Grade 1 | Potassium; Grade 2 | Potassium; Grade 3 | Potassium; Grade 4 | Sodium; Grade 1 | Sodium; Grade 2 | Sodium; Grade 3 | Sodium; Grade 4 | Total bilirubin; Grade 1 | Total bilirubin; Grade 2 | Total bilirubin; Grade 3 | Total bilirubin; Grade 4 | Triglycerides; Grade 1 | Triglycerides; Grade 2 | Triglycerides; Grade 3 | Triglycerides; Grade 4 | Urea/BUN; Grade 1 | Urea/BUN; Grade 2 | Urea/BUN; Grade 3 | Urea/BUN; Grade 4 |
---|
Efavirenz 600 mg | 8 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 6 | 1 | 2 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 9 | 6 | 0 | 4 | 1 | 2 | 4 | 1 | 1 | 0 | 0 | 6 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 8 | 2 | 0 | 6 | 5 | 1 | 0 | 6 | 8 | 2 | 0 | 2 | 1 | 0 | 0 | 8 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
,GSK1265744 10 mg | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 3 | 0 | 0 | 7 | 2 | 3 | 2 | 0 | 1 | 0 | 0 | 10 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 4 | 0 | 0 | 9 | 6 | 2 | 0 | 5 | 6 | 1 | 0 | 7 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 30 mg | 4 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 8 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 2 | 0 | 0 | 5 | 2 | 1 | 4 | 0 | 0 | 0 | 0 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 1 | 0 | 0 | 3 | 1 | 1 | 0 | 2 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 60 mg | 13 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 7 | 1 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 3 | 2 | 0 | 6 | 3 | 1 | 2 | 0 | 0 | 0 | 0 | 13 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 8 | 5 | 3 | 0 | 5 | 7 | 4 | 1 | 7 | 2 | 2 | 0 | 2 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 |
[back to top]
Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time
Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| APTT; Grade 1 | APTT; Grade 2 | APTT; Grade 3 | APTT; Grade 4 | Hemoglobin; Grade 1 | Hemoglobin; Grade 2 | Hemoglobin; Grade 3 | Hemoglobin; Grade 4 | INR; Grade 1 | INR; Grade 2 | INR; Grade 3 | INR; Grade 4 | Platelet count; Grade 1 | Platelet count; Grade 2 | Platelet count; Grade 3 | Platelet count; Grade 4 | PT; Grade 1 | PT; Grade 2 | PT; Grade 3 | PT; Grade 4 | Total neutrophils; Grade 1 | Total neutrophils; Grade 2 | Total neutrophils; Grade 3 | Total neutrophils; Grade 4 | WBC count; Grade 1 | WBC count; Grade 2 | WBC count; Grade 3 | WBC count; Grade 4 |
---|
Efavirenz 600 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 2 | 3 | 1 | 1 | 3 | 0 | 0 | 0 |
,GSK1265744 10 mg | 5 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 7 | 5 | 1 | 1 | 2 | 1 | 0 | 0 |
,GSK1265744 30 mg | 5 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 9 | 2 | 0 | 1 | 5 | 1 | 0 | 0 |
,GSK1265744 60 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 10 | 3 | 1 | 3 | 2 | 1 | 1 | 0 |
[back to top]
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase
Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Up to Week 24
Intervention | Participants (Count of Participants) |
---|
| APTT; Grade 1 | APTT; Grade 2 | APTT; Grade 3 | APTT; Grade 4 | Basophils; Grade 1 | Basophils; Grade 2 | Basophils; Grade 3 | Basophils; Grade 4 | Eosinophils; Grade 1 | Eosinophils; Grade 2 | Eosinophils; Grade 3 | Eosinophils; Grade 4 | Hematocrit; Grade 1 | Hematocrit; Grade 2 | Hematocrit; Grade 3 | Hematocrit; Grade 4 | Hemoglobin; Grade 1 | Hemoglobin; Grade 2 | Hemoglobin; Grade 3 | Hemoglobin; Grade 4 | INR; Grade 1 | INR; Grade 2 | INR; Grade 3 | INR; Grade 4 | Lymphocytes; Grade 1 | Lymphocytes; Grade 2 | Lymphocytes; Grade 3 | Lymphocytes; Grade 4 | MCV; Grade 1 | MCV; Grade 2 | MCV; Grade 3 | MCV; Grade 4 | Monocytes; Grade 1 | Monocytes; Grade 2 | Monocytes; Grade 3 | Monocytes; Grade 4 | Platelet count; Grade 1 | Platelet count; Grade 2 | Platelet count; Grade 3 | Platelet count; Grade 4 | PT; Grade 1 | PT; Grade 2 | PT; Grade 3 | PT; Grade 4 | RBC; Grade 1 | RBC; Grade 2 | RBC; Grade 3 | RBC; Grade 4 | Total neutrophils; Grade 1 | Total neutrophils; Grade 2 | Total neutrophils; Grade 3 | Total neutrophils; Grade 4 | WBC count; Grade 1 | WBC count; Grade 2 | WBC count; Grade 3 | WBC count; Grade 4 |
---|
Efavirenz 600 mg | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 1 | 0 | 0 | 0 |
,GSK1265744 10 mg | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
,GSK1265744 30 mg | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 6 | 2 | 0 | 0 | 2 | 1 | 0 | 0 |
,GSK1265744 60 mg | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 3 | 0 | 1 | 2 | 0 | 0 | 0 |
[back to top]
Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase
Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. (NCT01641809)
Timeframe: Week 24 to Week 96
Intervention | Participants (Count of Participants) |
---|
| APTT; Grade 1 | APTT; Grade 2 | APTT; Grade 3 | APTT; Grade 4 | Hemoglobin; Grade 1 | Hemoglobin; Grade 2 | Hemoglobin; Grade 3 | Hemoglobin; Grade 4 | INR; Grade 1 | INR; Grade 2 | INR; Grade 3 | INR; Grade 4 | Platelet count; Grade 1 | Platelet count; Grade 2 | Platelet count; Grade 3 | Platelet count; Grade 4 | PT; Grade 1 | PT; Grade 2 | PT; Grade 3 | PT; Grade 4 | Total neutrophils; Grade 1 | Total neutrophils; Grade 2 | Total neutrophils; Grade 3 | Total neutrophils; Grade 4 | WBC count; Grade 1 | WBC count; Grade 2 | WBC count; Grade 3 | WBC count; Grade 4 |
---|
Efavirenz 600 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 2 | 3 | 1 | 1 | 3 | 0 | 0 | 0 |
,GSK1265744 10 mg | 5 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 4 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 7 | 5 | 1 | 1 | 2 | 1 | 0 | 0 |
,GSK1265744 30 mg | 5 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 1 | 9 | 2 | 0 | 1 | 5 | 1 | 0 | 0 |
,GSK1265744 60 mg | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 4 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 10 | 3 | 1 | 3 | 2 | 1 | 1 | 0 |
[back to top]
Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease
HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| CDC Class A to CDC Class C | CDC Class B to CDC Class C | CDC Class C to new CDC Class C | CDC Class A, B or C to Death |
---|
Efavirenz 600 mg | 0 | 0 | 0 | 0 |
,GSK1265744 10 mg | 1 | 0 | 0 | 0 |
,GSK1265744 30 mg | 1 | 0 | 0 | 1 |
,GSK1265744 60 mg | 0 | 0 | 0 | 1 |
[back to top]
Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance
Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| Any INI mutation | Any mutation to other classes |
---|
Efavirenz 600 mg | 0 | 0 |
,GSK1265744 10 mg | 3 | 4 |
,GSK1265744 30 mg | 0 | 0 |
,GSK1265744 60 mg | 1 | 1 |
[back to top]
Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures. (NCT01641809)
Timeframe: Up to Week 324
Intervention | Participants (Count of Participants) |
---|
| INI, GSK1265744; Resistant; n=5, 1, 2, 2 | INI, GSK1265744; Sensitive; n=5, 1, 2, 2 | INI, RAL; Resistant; n=5, 1, 2, 2 | INI, RAL; Sensitive; n=5, 1, 2, 2 | NNRTI, DLV; Resistant; n=6, 2, 2, 5 | NNRTI, DLV; Sensitive; n=6, 2, 2, 5 | NNRTI, EFV; Resistant; n=6, 2, 2, 5 | NNRTI, EFV; Sensitive; n=6, 2, 2, 5 | NNRTI, ETR; Resistant; n=6, 2, 2, 5 | NNRTI, ETR; Partially sensitive; n=6, 2, 2, 5 | NNRTI, ETR; Sensitive; n=6, 2, 2, 5 | NNRTI, NVP; Resistant; n=6, 2, 2, 5 | NNRTI, NVP; Sensitive; n=6, 2, 2, 5 | NNRTI, RPV; Resistant; n=6, 2, 2, 5 | NNRTI, RPV; Sensitive; n=6, 2, 2, 5 | NRTI, 3TC; Resistant; n=6, 2, 2, 5 | NRTI, 3TC; Sensitive; n=6, 2, 2, 5 | NRTI, ABC; Resistant; n=6, 2, 2, 5 | NRTI, ABC; Partially sensitive; n=6, 2, 2, 5 | NRTI, ABC; Sensitive; n=6, 2, 2, 5 | NRTI, FTC; Resistant; n=6, 2, 2, 5 | NRTI, FTC; Sensitive; n=6, 2, 2, 5 | NRTI, TDF; Resistant; n=6, 2, 2, 5 | NRTI, TDF; Partially sensitive; n=6, 2, 2, 5 | NRTI, TDF; Sensitive; n=6, 2, 2, 5 | NRTI, ZDV; Resistant; n=6, 2, 2, 5 | NRTI, ZDV; Sensitive; n=6, 2, 2, 5 | NRTI, d4T; Resistant; n=6, 2, 2, 5 | NRTI, d4T; Sensitive; n=6, 2, 2, 5 | NRTI, ddI; Resistant; n=6, 2, 2, 5 | NRTI, ddI; Partially sensitive; n=6, 2, 2, 5 | NRTI, ddI; Sensitive; n=6, 2, 2, 5 | PI, ATV/r; Resistant; n=6, 2, 2, 5 | PI, ATV/r; Sensitive; n=6, 2, 2, 5 | PI, DRV/r; Resistant; n=6, 2, 2, 5 | PI, DRV/r; Partially sensitive; n=6, 2, 2, 5 | PI, DRV/r; Sensitive; n=6, 2, 2, 5 | PI, FPV/r; Resistant; n=6, 2, 2, 5 | PI, FPV/r; Partially sensitive; n=6, 2, 2, 5 | PI, FPV/r; Sensitive; n=6, 2, 2, 5 | PI, IDV/r; Resistant; n=6, 2, 2, 5 | PI, IDV/r; Sensitive; n=6, 2, 2, 5 | PI, LPV/r; Resistant; n=6, 2, 2, 5 | PI, LPV/r; Partially sensitive; n=6, 2, 2, 5 | PI, LPV/r; Sensitive; n=6, 2, 2, 5 | PI, NFV; Resistant; n=6, 2, 2, 5 | PI, NFV; Sensitive; n=6, 2, 2, 5 | PI, RTV; Resistant; n=6, 2, 2, 5 | PI, RTV; Sensitive; n=6, 2, 2, 5 | PI, SQV/r; Resistant; n=6, 2, 2, 5 | PI, SQV/r; Partially sensitive; n=6, 2, 2, 5 | PI, SQV/r; Sensitive; n=6, 2, 2, 5 | PI, TPV/r; Resistant; n=6, 2, 2, 5 | PI, TPV/r; Partially sensitive; n=6, 2, 2, 5 | PI, TPV/r; Sensitive; n=6, 2, 2, 5 |
---|
Efavirenz 600 mg | 0 | 2 | 0 | 2 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 5 |
,GSK1265744 10 mg | 2 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 0 | 3 | 3 | 3 | 3 | 3 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 1 | 5 | 2 | 4 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 0 | 6 | 0 | 6 | 0 | 6 | 0 | 0 | 6 | 0 | 0 | 6 |
,GSK1265744 30 mg | 0 | 1 | 0 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 |
,GSK1265744 60 mg | 1 | 1 | 1 | 1 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 2 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Week 16 and Week 24
Intervention | Percentage of participants (Number) |
---|
| Week 16 | Week 24 |
---|
Efavirenz 600 mg | 74 | 74 |
,GSK1265744 10 mg | 90 | 87 |
,GSK1265744 30 mg | 83 | 85 |
,GSK1265744 60 mg | 87 | 87 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study. (NCT01641809)
Timeframe: Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Percentage of participants (Number) |
---|
| Week 24 | Week 26 | Week 28 | Week 32 | Week 36 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
---|
Efavirenz 600 mg | 96 | 87 | 91 | 91 | 94 | 89 | 94 | 89 | 89 | 89 | 83 |
,GSK1265744 10 mg | 96 | 90 | 98 | 96 | 98 | 96 | 92 | 90 | 83 | 83 | 79 |
,GSK1265744 30 mg | 94 | 85 | 89 | 91 | 92 | 92 | 91 | 83 | 83 | 85 | 85 |
,GSK1265744 60 mg | 96 | 95 | 95 | 96 | 95 | 95 | 96 | 95 | 95 | 95 | 93 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm
Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Percentage of participants (Number) |
---|
| Baseline | Week 2 | Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | Week 26 | Week 28 | Week 32 | Week 36 | Week 40 | Week 48 | Week 60 | Week 72 | Week 84 | Week 96 |
---|
Efavirenz 600 mg | 0 | 68 | 68 | 79 | 73 | 81 | 79 | 71 | 73 | 73 | 73 | 73 | 73 | 71 | 68 | 68 | 65 |
,GSK1265744 10 mg | 0 | 87 | 93 | 93 | 90 | 93 | 93 | 80 | 85 | 87 | 87 | 87 | 83 | 80 | 77 | 77 | 75 |
,GSK1265744 30 mg | 0 | 80 | 93 | 92 | 85 | 87 | 87 | 80 | 83 | 85 | 85 | 85 | 85 | 77 | 75 | 77 | 77 |
,GSK1265744 60 mg | 0 | 84 | 93 | 92 | 89 | 93 | 92 | 87 | 85 | 89 | 90 | 90 | 89 | 87 | 85 | 85 | 85 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96
Intervention | Percentage of participants (Number) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 0 | 71 | 74 | 91 | 92 | 96 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 98 | 100 | 100 | 100 |
,GSK1265744 10 mg | 0 | 91 | 97 | 95 | 97 | 98 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 98 | 96 | 98 | 100 | 96 |
,GSK1265744 30 mg | 0 | 86 | 98 | 98 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 98 | 100 | 96 | 98 | 100 |
,GSK1265744 60 mg | 0 | 86 | 97 | 98 | 98 | 100 | 100 | 100 | 100 | 100 | 98 | 100 | 100 | 100 | 100 | 100 | 100 | 100 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase. (NCT01641809)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324
Intervention | Percentage of participants (Number) |
---|
| Baseline; n=60, 60, 61, 62 | Week 2; n=57, 56, 59, 59 | Week 4; n=58, 57, 59, 57 | Week 8; n=59, 56, 57, 55 | Week 12; n=58, 52, 57, 51 | Week 16; n=57, 54, 57, 52 | Week 20; n=56, 54, 56, 47 | Week 24; n=56, 53, 56, 48 | Week 26; n=48, 50, 53, 44 | Week 28; n=51, 52, 52, 45 | Week 32; n=52, 53, 55, 45 | Week 36; n=52, 53, 55, 45 | Week 40; n=52, 53, 55, 45 | Week 48; n=51, 53, 54, 44 | Week 60; n=48, 48, 53, 44 | Week 72; n=47, 48, 52, 42 | Week 84; n=46, 48, 52, 42 | Week 96; n=45, 48, 52, 40 |
---|
Efavirenz 600 mg | 0 | 14 | 26 | 55 | 76 | 87 | 91 | 96 | 93 | 96 | 96 | 98 | 93 | 98 | 95 | 100 | 100 | 98 |
[back to top]
Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma
Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | log10 ng/mL (Mean) |
---|
| Mid-Period FTC Concentration | End Period FTC Concentration |
---|
Product 1 | 2.34 | 2.25 |
,Product 2 | -0.35 | -0.37 |
,Product 3 | -0.37 | -0.33 |
[back to top]
Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period
Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | Participants (Count of Participants) |
---|
| Less Than 80% | At or Greater than 80% |
---|
Product 1 | 12 | 173 |
,Product 2 | 31 | 153 |
,Product 3 | 13 | 170 |
[back to top]
Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | participants (Number) |
---|
| Disliked Very Much/A Little | Liked Very Much/A Little |
---|
Product 1 | 16 | 163 |
,Product 2 | 47 | 134 |
,Product 3 | 38 | 145 |
[back to top]
Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | participants (Number) |
---|
| Very Unlikely/Unlikely | Very Likely/Likely |
---|
Product 1 | 24 | 159 |
,Product 2 | 52 | 132 |
,Product 3 | 31 | 145 |
[back to top]
Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?
To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | participants (Number) |
---|
| Very Difficult/Difficult | Very Easy/Easy |
---|
Product 1 | 14 | 169 |
,Product 2 | 24 | 160 |
,Product 3 | 18 | 165 |
[back to top]
Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge
Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | log10 ng/mg (Mean) |
---|
| Initiate Period FTC Concentration | Mid-Period FTC Concentration | End Period FTC Concentration |
---|
Product 1 | -1.75 | 0.31 | 0.14 |
,Product 2 | -1.76 | -1.76 | -1.80 |
,Product 3 | -1.57 | -1.67 | -1.69 |
[back to top]
Safety: Grade 2 or Higher Adverse Events
Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold). (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | participants (Number) |
---|
Product 1 | 64 |
Product 2 | 61 |
Product 3 | 56 |
[back to top]
Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue
Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | log10 ng/mg (Mean) |
---|
Product 1 | 1.52 |
Product 2 | 2.06 |
Product 3 | 1.54 |
[back to top]
Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue
Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | log10 ng/mg (Mean) |
---|
Product 1 | -0.35 |
Product 2 | -1.26 |
Product 3 | -1.26 |
[back to top]
Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue
Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | log10 ng/mg (Mean) |
---|
Product 1 | 0.18 |
Product 2 | 0.84 |
Product 3 | 0.02 |
[back to top]
Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma
Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | log10 ng/mL (Mean) |
---|
| Mid-Period TFV Concentration | End Period TFV Concentration |
---|
Product 1 | 1.85 | 1.77 |
,Product 2 | 0.42 | 0.37 |
,Product 3 | -0.01 | -0.02 |
[back to top]
Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge
Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups. (NCT01687218)
Timeframe: 27 weeks (three 8-week product use periods with 1-week washout periods between them)
Intervention | log10 ng/mg (Mean) |
---|
| Initiate Period TFV Concentration | Mid-Period TFV Concentration | End Period TFV Concentration |
---|
Product 1 | -1.53 | 0.71 | 0.66 |
,Product 2 | -1.65 | 0.97 | 1.00 |
,Product 3 | -1.29 | -0.03 | 0.01 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 0.5 |
TDF/FTC/EFV | 0.5 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48
Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 93.9 |
TDF/FTC/EFV | 96.2 |
[back to top]
Percentage of Participant With Treatment Adherence Based on Tablet Count
In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively). (NCT01709084)
Timeframe: Up to 48 Weeks
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 97.2 |
TDF/FTC/EFV | 97.6 |
[back to top]
Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations
To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups. (NCT01709084)
Timeframe: Up to Week 48
Intervention | Participants (Number) |
---|
TDF/FTC/RPV | 0 |
TDF/FTC/EFV | 0 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.
Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 1.5 |
TDF/FTC/EFV | 1.0 |
[back to top]
Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48
Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method. (NCT01709084)
Timeframe: Week 48
Intervention | Percentage of Participants (Number) |
---|
TDF/FTC/RPV | 93.9 |
TDF/FTC/EFV | 96.2 |
[back to top]
Total Body Bone Mineral Density: Percent Change From Baseline to Week 48
"The percent change in total body BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
PCC Behavioral Intervention Group | 1.29 |
[back to top]
Number of Participants Using Text Messaging Reminders
This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders. (NCT01769456)
Timeframe: Baseline through Week 48
Intervention | Participants (Count of Participants) |
---|
| Signed up for text message reminders | Discontinued reminders while on study agent | Discontinued reminders while still on study |
---|
PCC Behavioral Intervention Group | 22 | 2 | 1 |
[back to top]
Number of Participants With Decrease in Bone Mineral Density
"The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Decrease in absolute BMD >=1% baseline to Wk48 | Decrease in absolute BMD >=5% baseline to Wk48 | Decrease in absolute BMD >10% baseline to Wk48 |
---|
PCC Behavioral Intervention Group | 16 | 2 | 0 |
[back to top]
Acceptability of PrEP Regimen and Study Visits
"This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions." (NCT01769456)
Timeframe: Week 12
Intervention | Participants (Count of Participants) |
---|
| Size of the pill71989854 | Taste of the pill71989854 | Color of the pill71989854 | Taking the pill every day71989854 | Taking part in the study71989854 | HIV test at every visit71989854 | Risk Reduction Counseling at every visit71989854 | Questions about sexual behavior at every visit71989854 | Physician exam by a doctor71989854 | Health clinic for study visits71989854 |
---|
| Did not like it at all | Liked | Did not like | Liked a lot |
---|
PCC Behavioral Intervention Group | 14 |
PCC Behavioral Intervention Group | 36 |
PCC Behavioral Intervention Group | 6 |
PCC Behavioral Intervention Group | 27 |
PCC Behavioral Intervention Group | 22 |
PCC Behavioral Intervention Group | 3 |
PCC Behavioral Intervention Group | 2 |
PCC Behavioral Intervention Group | 8 |
PCC Behavioral Intervention Group | 42 |
PCC Behavioral Intervention Group | 9 |
PCC Behavioral Intervention Group | 1 |
PCC Behavioral Intervention Group | 17 |
PCC Behavioral Intervention Group | 34 |
PCC Behavioral Intervention Group | 7 |
PCC Behavioral Intervention Group | 0 |
PCC Behavioral Intervention Group | 26 |
PCC Behavioral Intervention Group | 35 |
PCC Behavioral Intervention Group | 4 |
PCC Behavioral Intervention Group | 25 |
PCC Behavioral Intervention Group | 32 |
PCC Behavioral Intervention Group | 30 |
PCC Behavioral Intervention Group | 10 |
PCC Behavioral Intervention Group | 15 |
PCC Behavioral Intervention Group | 41 |
[back to top]
Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48
"The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
PCC Behavioral Intervention Group | 1.27 |
[back to top]
Rating of the Reasons for Missing Medications on a 4-point Likert Scale.
"This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.~Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:" (NCT01769456)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Were away from home71989854 | Were too busy with other things71989854 | Simply forgot71989854 | Had too many study pills to take71989854 | Wanted to avoid side effects71989854 | Did not want others to notice you taking meds71989854 | Had a change in daily routine71989854 |
---|
| Rarely | Sometimes | Often | Never |
---|
PCC Behavioral Intervention Group | 12 |
PCC Behavioral Intervention Group | 15 |
PCC Behavioral Intervention Group | 10 |
PCC Behavioral Intervention Group | 7 |
PCC Behavioral Intervention Group | 8 |
PCC Behavioral Intervention Group | 21 |
PCC Behavioral Intervention Group | 37 |
PCC Behavioral Intervention Group | 2 |
PCC Behavioral Intervention Group | 36 |
PCC Behavioral Intervention Group | 3 |
PCC Behavioral Intervention Group | 0 |
PCC Behavioral Intervention Group | 1 |
PCC Behavioral Intervention Group | 27 |
PCC Behavioral Intervention Group | 5 |
PCC Behavioral Intervention Group | 4 |
[back to top]
Estimation of Medication Adherence by Dried Blood Spot (DBS) Results
"This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.~The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch).~The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)" (NCT01769456)
Timeframe: Week 4, Week 12, Week 24, Week 36, Week 48
Intervention | Participants (Count of Participants) |
---|
| DBS RBC TFV-DP (fmol/punch), Week 471989854 | DBS RBC TFV-DP (fmol/punch), Week 871989854 | DBS RBC TFV-DP (fmol/punch), Week 1271989854 | DBS RBC TFV-DP (fmol/punch), Week 2471989854 | DBS RBC TFV-DP (fmol/punch), Week 3671989854 | DBS RBC TFV-DP (fmol/punch), Week 4871989854 |
---|
| 2 days | 4 days | Daily | Below level of quantification | <2 days |
---|
PCC Behavioral Intervention Group | 24 |
PCC Behavioral Intervention Group | 13 |
PCC Behavioral Intervention Group | 14 |
PCC Behavioral Intervention Group | 21 |
PCC Behavioral Intervention Group | 12 |
PCC Behavioral Intervention Group | 3 |
PCC Behavioral Intervention Group | 17 |
PCC Behavioral Intervention Group | 7 |
PCC Behavioral Intervention Group | 22 |
PCC Behavioral Intervention Group | 11 |
PCC Behavioral Intervention Group | 15 |
PCC Behavioral Intervention Group | 18 |
PCC Behavioral Intervention Group | 5 |
PCC Behavioral Intervention Group | 6 |
PCC Behavioral Intervention Group | 19 |
PCC Behavioral Intervention Group | 8 |
PCC Behavioral Intervention Group | 2 |
PCC Behavioral Intervention Group | 4 |
[back to top]
Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners
"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:~Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Week 48
Intervention | male sexual partners (Mean) |
---|
PCC Behavioral Intervention Group | 1.64 |
[back to top]
Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex
"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:~Of these males [male partners], how many did you have unprotected oral or anal sex with since the last time you took this survey? An event is defined as an answer of greater than 0.~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
PCC Behavioral Intervention Group | 25 |
[back to top]
Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48
"The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
PCC Behavioral Intervention Group | 1.16 |
[back to top]
Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48
"The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM." (NCT01769456)
Timeframe: Baseline, Week 48
Intervention | percent change (Mean) |
---|
PCC Behavioral Intervention Group | 2.59 |
[back to top]
Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study
"This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.~Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48)." (NCT01769456)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
PCC Behavioral Intervention Group | 0 |
[back to top]
Total Body Bone Mineral Density at Baseline and at Week 48
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total body." (NCT01772823)
Timeframe: Baseline, Week 48
Intervention | g/cm2 (Mean) |
---|
| Total body BMD at baseline | Total body BMD Week 48 |
---|
All Study Participants | 1.20 | 1.18 |
[back to top]
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure
"This outcome addresses the objective: Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily)." (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Intervention | Participants (Count of Participants) |
---|
| Week 471977136 | Week 871977136 | Week 1271977136 | Week 2471977136 | Week 3671977136 | Week 4871977136 |
---|
| Below level of quantification | <2 days | 2 days | 4 days | Daily |
---|
All Study Participants | 13 |
All Study Participants | 35 |
All Study Participants | 58 |
All Study Participants | 59 |
All Study Participants | 8 |
All Study Participants | 7 |
All Study Participants | 30 |
All Study Participants | 69 |
All Study Participants | 12 |
All Study Participants | 32 |
All Study Participants | 26 |
All Study Participants | 55 |
All Study Participants | 34 |
All Study Participants | 36 |
All Study Participants | 14 |
All Study Participants | 42 |
All Study Participants | 27 |
All Study Participants | 23 |
All Study Participants | 28 |
All Study Participants | 37 |
All Study Participants | 24 |
All Study Participants | 18 |
All Study Participants | 15 |
[back to top]
Number of Participants With Unprotected Sex Acts
"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to male partners in the past month/since the last survey:~Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month? (Baseline), or Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? (Week 48) An event is defined as an answer of greater than 0." (NCT01772823)
Timeframe: Baseline and 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Had unprotected oral/anal w/male (BL) | Had unprotected oral/anal w/ male (Wk48) |
---|
All Study Participants | 143 | 103 |
[back to top]
Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48
"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48." (NCT01772823)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Decrease in absolute BMD >=1% | Decrease in absolute BMD >=5% | Decrease in absolute BMD >10% |
---|
All Study Participants | 97 | 16 | 1 |
[back to top]
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
"This outcome addresses the objective: Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations." (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Intervention | fmol/punch (Mean) |
---|
| DBS RBC TFV-DP at Week 4 | DBS RBC TFV-DP at Week 8 | DBS RBC TFV-DP at Week 12 | DBS RBC TFV-DP at Week 24 | DBS RBC TFV-DP at Week 36 | DBS RBC TFV-DP at Week 48 |
---|
All Study Participants | 584.56 | 783.18 | 793.37 | 657.66 | 671.72 | 528.24 |
[back to top]
Lumbar Spine Bone Mineral Density at Baseline and at Week 48
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for lumbar spine." (NCT01772823)
Timeframe: Baseline, Week 48
Intervention | g/cm2 (Mean) |
---|
| Lumbar spine BMD at baseline | Lumbar spine BMD Week 48 |
---|
All Study Participants | 1.09 | 1.08 |
[back to top]
Femoral Neck Bone Mineral Density at Baseline and at Week 48
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for femoral neck." (NCT01772823)
Timeframe: Baseline, Week 48
Intervention | g/cm2 (Mean) |
---|
| Femoral neck BMD at baseline | Femoral neck Week 48 |
---|
All Study Participants | 1.04 | 1.03 |
[back to top]
Number of Participants With Serum Creatinine Event of Grade 1 or Higher
"This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM~Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal." (NCT01772823)
Timeframe: 48 Weeks
Intervention | Participants (Count of Participants) |
---|
All Study Participants | 1 |
[back to top]
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)
"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)" (NCT01772823)
Timeframe: 48 weeks
Intervention | copies/ml (Mean) |
---|
On Prep | 1.22 |
Off Prep | 1.14 |
[back to top]
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)
PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations. (NCT01772823)
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Intervention | pmol/punch (Mean) |
---|
| DBS RBC FTC-TP at Week 4 | DBS RBC FTC-TP at Week 8 | DBS RBC FTC-TP at Week 12 | DBS RBC FTC-TP at Week 24 | DBS RBC FTC-TP at Week 36 | DBS RBC FTC-TP at Week 48 |
---|
All Study Participants | 0.20 | 0.19 | 0.18 | 0.16 | 0.17 | 0.15 |
[back to top]
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)
"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's age at enrollment." (NCT01772823)
Timeframe: 48 weeks
Intervention | years (Mean) |
---|
On Prep | 20.28 |
Off Prep | 19.93 |
[back to top]
Number of Sex Partners
"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:~During the past month, how many male partners have you had sexual contact with (oral or anal)? (Baseline), or Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)? (Week 48)~And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:~Of those you had unprotected sex with, how many did you know were HIV positive?" (NCT01772823)
Timeframe: Baseline and 48 weeks
Intervention | sexual partners (Mean) |
---|
| Male sexual partners last month (baseline) | Male sexual partners since last survey (Wk 48) | Number HIV+ male partners last month (baseline) | Number HIV+ male partners since last survey(Wk48) |
---|
All Study Participants | 5.41 | 2.46 | 1.65 | 0.15 |
[back to top]
Total Hip Bone Mineral Density at Baseline and at Week 48
"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total hip." (NCT01772823)
Timeframe: Baseline, Week 48
Intervention | g/cm2 (Mean) |
---|
| Total hip BMD at baseline | Total hip BMD Week 48 |
---|
All Study Participants | 1.10 | 1.08 |
[back to top]
Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders
Number of subjects who discontinued receiving text message reminders while they were still on the study agent (NCT01772823)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
All Study Participants | 3 |
[back to top]
Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders
Total number of subjects who signed up for text message reminders (NCT01772823)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
All Study Participants | 76 |
[back to top]
Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)
Grading uses the Division of AIDS (DAIDS) 2004 (clarification 2009) Severity of Adverse Events Table, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening. (NCT01777997)
Timeframe: From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation
Intervention | participants (Number) |
---|
FTC/RPV/TDF | 18 |
[back to top]
Change in CD4+ T-cell Count
Change equals each specific week CD4+ T-cell count, respectively, minus the baseline CD4+ T-cell count (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ART
Intervention | cells/mm^3 (Median) |
---|
| Week 12 on ART | Week 24 on ART | Week 36 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | -15 | -5 | 25 | 19 |
[back to top]
Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)
Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Intervention | % of CD4+ T-cells (Median) |
---|
| Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.1 | -0.1 | -0.2 | -0.2 |
[back to top]
Change in Levels of Interleukin (IL)-6
Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Intervention | log10(pg/mL) (Median) |
---|
| Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.05 | 0.01 | 0.02 | 0 |
[back to top]
Change in Quality of Life (QoL) Index
"QoL index was obtained by averaging the five responses on the Euro-Quality of Life questionnaire (EQ-5D), where a response of 0 indicates no problems/no discomfort, 1 indicates some problems/moderate discomfort and 2 indicates unable to perform activities/extreme discomfort. Change equals each specific week index, respectively, minus the baseline index (mean of the two averages obtained prior to the start of ART)" (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART
Intervention | units on a scale (Median) |
---|
| Week 4 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0 | -0.1 | 0 |
[back to top]
Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay
At a specific week, the proportion of participants with HIV-1 RNA by iSCA less than assay limit of detection (0.6 copies/mL) (NCT01777997)
Timeframe: At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ART
Intervention | proportion of participants (Number) |
---|
| Pre-ART | Week 0 on ART | Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 36 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.19 | 0.19 | 0.61 | 0.90 | 0.93 | 0.92 | 0.96 |
[back to top]
Change in Levels of D-dimer
Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART
Intervention | log10(ng/mL) (Median) |
---|
| Week 4 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | 0.01 | 0.01 | 0.02 |
[back to top]
Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART
Mean change from baseline (pre-ART [study entry] and week 0 on ART [study week 12]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART
Intervention | % of CD8+ T-cells (Mean) |
---|
FTC/RPV/TDF | -4.01 |
[back to top]
Change in Levels of CD8+ T-cell Activation
Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART) (NCT01777997)
Timeframe: From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART
Intervention | % of CD8+ T-cells (Median) |
---|
| Week 4 on ART | Week 12 on ART | Week 24 on ART | Week 48 on ART |
---|
FTC/RPV/TDF | -0.7 | -1.6 | -2.2 | -4.7 |
[back to top]
Cohort H PrEP Engagement by Study Visit
Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days). (NCT01781806)
Timeframe: Baseline to 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 12 | Week 24 | Week 36 | Week 48 |
---|
Cohort H (PrEP) | 246 | 247 | 224 | 212 | 194 |
[back to top]
Number of HIV Seroconversions by Cohort.
(NCT01781806)
Timeframe: Baseline to 48 weeks
Intervention | Participants (Count of Participants) |
---|
Cohort H (PrEP) | 1 |
Cohort LM (PEP) | 0 |
[back to top]
Number of Participants With a Grade 2 or Higher Adverse Event by Cohort
Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort. (NCT01781806)
Timeframe: Baseline to 48 weeks
Intervention | Participants (Count of Participants) |
---|
Cohort H (PrEP) | 230 |
Cohort LM (PEP) | 0 |
[back to top]
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10
Intervention | Nanogram*hour/milliliter (Geometric Mean) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 1151.062 | 2720.237 |
,Part A-Group 10: BMS-955176 (120 mg) | 21872.72 | 44182.4 |
,Part A-Group 2: BMS-955176 (10 mg) | 2869.626 | 5168.553 |
,Part A-Group 3: BMS-955176 (20 mg) | 5132.951 | 11751.82 |
,Part A-Group 4: BMS-955176 (40 mg) | 10088.23 | 22984.83 |
,Part A-Group 9: BMS-955176 (80 mg) | 17057.26 | 39341.11 |
,Part C-Group 13: BMS-955176 (120 mg) | 26753.74 | 53972.71 |
,Part C-Group 8: BMS-955176 (40 mg) | 10936.9 | 25556.64 |
[back to top]
Plasma Concentration 24 Hours Post-Dose (C24) - Part B
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. (NCT01803074)
Timeframe: 24 hours post-dose
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 899.364 | 2010.679 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 462.312 | 1099.313 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 520.048 | 1163.177 |
[back to top]
Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline
Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004. (NCT01803074)
Timeframe: Day 1 to up to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| Neutrophils (Absolute) | Bilirubin (Total) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 1 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 0 | 0 |
,Part A-Group 3: BMS-955176 (20 mg) | 0 | 0 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 1 | 0 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 2 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 0 | 5 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 0 | 3 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 0 | 0 |
,Placebo Clade B | 0 | 0 |
,Placebo Clade C | 0 | 0 |
[back to top]
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Percent change (Mean) |
---|
| CD4+ | CD8+ |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -0.75 | -1.25 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 2.4 | -2.8 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 3.25 | -6.25 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 4.75 | -3.75 |
[back to top]
Apparent Total Body Clearance: Part A and C
Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Milliliters/minute (Geometric Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 30.635 |
Part A-Group 2: BMS-955176 (10 mg) | 32.246 |
Part A-Group 3: BMS-955176 (20 mg) | 28.364 |
Part A-Group 4: BMS-955176 (40 mg) | 29.005 |
Part A-Group 9: BMS-955176 (80 mg) | 33.892 |
Part A-Group 10: BMS-955176 (120 mg) | 45.267 |
Part C-Group 8: BMS-955176 (40 mg) | 26.086 |
Part C-Group 13: BMS-955176 (120 mg) | 37.056 |
[back to top]
Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C
Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 113.326 |
Part A-Group 2: BMS-955176 (10 mg) | 215.111 |
Part A-Group 3: BMS-955176 (20 mg) | 489.507 |
Part A-Group 4: BMS-955176 (40 mg) | 956.222 |
Part A-Group 9: BMS-955176 (80 mg) | 1639.471 |
Part A-Group 10: BMS-955176 (120 mg) | 1841.413 |
Part C-Group 8: BMS-955176 (40 mg) | 1065.435 |
Part C-Group 13: BMS-955176 (120 mg) | 2256.793 |
[back to top]
Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) and Day 11 after the final dose with BMS-955176
Intervention | Log10 copies per milliliter (c/mL) (Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | -0.138 |
Part A-Group 2: BMS-955176 (10 mg) | -0.567 |
Part A-Group 3: BMS-955176 (20 mg) | -0.889 |
Part A-Group 4: BMS-955176 (40 mg) | -1.279 |
Part A-Group 9: BMS-955176 (80 mg) | -1.339 |
Part A-Group 10: BMS-955176 (120 mg) | -1.326 |
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | -1.216 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | -1.431 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | -1.544 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -1.521 |
Part C-Group 8: BMS-955176 (40 mg) | -1.29 |
Part C-Group 13: BMS-955176 (120 mg) | -0.938 |
Placebo Clade B | 0.118 |
Placebo Clade C | -0.172 |
[back to top]
Degree of Fluctuation (DF): Part A and C
DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Ratio (Geometric Mean) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0.766 |
Part A-Group 2: BMS-955176 (10 mg) | 0.912 |
Part A-Group 3: BMS-955176 (20 mg) | 0.758 |
Part A-Group 4: BMS-955176 (40 mg) | 0.78 |
Part A-Group 9: BMS-955176 (80 mg) | 0.779 |
Part A-Group 10: BMS-955176 (120 mg) | 0.818 |
Part C-Group 8: BMS-955176 (40 mg) | 0.723 |
Part C-Group 13: BMS-955176 (120 mg) | 0.727 |
[back to top]
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Log10 copies/mL (Median) |
---|
Part A-Group 1: BMS-955176 (5 mg) | -0.498 |
Part A-Group 2: BMS-955176 (10 mg) | -0.976 |
Part A-Group 3: BMS-955176 (20 mg) | -1.115 |
Part A-Group 4: BMS-955176 (40 mg) | -1.701 |
Part A-Group 9: BMS-955176 (80 mg) | -1.555 |
Part A-Group 10: BMS-955176 (120 mg) | -1.654 |
Part C-Group 8: BMS-955176 (40 mg) | -1.352 |
Part C-Group 13: BMS-955176 (120 mg) | -1.257 |
Placebo Clade B | -0.381 |
Placebo Clade C | -0.419 |
[back to top]
Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Log10 copies/mL (Median) |
---|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | -1.858 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | -2.202 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | -2.39 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -2.228 |
[back to top]
Number of Participants With Clinically Significant Changes in Heart Rate
Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value >100 and change from Baseline > 30, or Value < 55 and change from Baseline < -15. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 |
Part A-Group 2: BMS-955176 (10 mg) | 0 |
Part A-Group 3: BMS-955176 (20 mg) | 0 |
Part A-Group 4: BMS-955176 (40 mg) | 0 |
Part A-Group 9: BMS-955176 (80 mg) | 0 |
Part A-Group 10: BMS-955176 (120 mg) | 0 |
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 0 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 1 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 0 |
Part C-Group 8: BMS-955176 (40 mg) | 0 |
Part C-Group 13: BMS-955176 (120 mg) | 2 |
Placebo Clade B | 1 |
Placebo Clade C | 0 |
[back to top]
Plasma Half-life: Part A and C
Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7). (NCT01803074)
Timeframe: Baseline (Day 1) to Day 10
Intervention | Hours (Median) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 32.134 |
Part A-Group 2: BMS-955176 (10 mg) | 31.967 |
Part A-Group 3: BMS-955176 (20 mg) | 27.382 |
Part A-Group 4: BMS-955176 (40 mg) | 33.475 |
Part A-Group 9: BMS-955176 (80 mg) | 29.171 |
Part A-Group 10: BMS-955176 (120 mg) | 34.574 |
Part C-Group 8: BMS-955176 (40 mg) | 31.565 |
Part C-Group 13: BMS-955176 (120 mg) | 35.278 |
[back to top]
Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Hours (Median) |
---|
Part A-Group 1: BMS-955176 (5 mg) | 168 |
Part A-Group 2: BMS-955176 (10 mg) | 216 |
Part A-Group 3: BMS-955176 (20 mg) | 203.9 |
Part A-Group 4: BMS-955176 (40 mg) | 240.15 |
Part A-Group 9: BMS-955176 (80 mg) | 204 |
Part A-Group 10: BMS-955176 (120 mg) | 240.2 |
Part C-Group 8: BMS-955176 (40 mg) | 228.05 |
Part C-Group 13: BMS-955176 (120 mg) | 215.8 |
Placebo Clade B | 216.2 |
Placebo Clade C | 132.05 |
[back to top]
Time to Maximum Decline in Log 10 HIV-1 RNA - Part B
Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Hours (Median) |
---|
Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 624 |
Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 636.05 |
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 588 |
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 636.05 |
[back to top]
Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C
Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Percent change (Mean) |
---|
| CD4+ | CD8+ |
---|
Part A-Group 1: BMS-955176 (5 mg) | 2.33 | 1.17 |
,Part A-Group 10: BMS-955176 (120 mg) | 0.29 | -2.29 |
,Part A-Group 2: BMS-955176 (10 mg) | 0.29 | 0.43 |
,Part A-Group 3: BMS-955176 (20 mg) | -1.29 | 0 |
,Part A-Group 4: BMS-955176 (40 mg) | 0.86 | 1 |
,Part A-Group 9: BMS-955176 (80 mg) | 2.13 | -0.25 |
,Part C-Group 13: BMS-955176 (120 mg) | 3.17 | -4.25 |
,Part C-Group 8: BMS-955176 (40 mg) | 0.5 | 0 |
,Placebo Clade B | -0.22 | 1.75 |
,Placebo Clade C | 2.75 | -1.33 |
[back to top]
Accumulation Index (AI): Part A and C
Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1. (NCT01803074)
Timeframe: Baseline and Day 10
Intervention | Ratio (Geometric Mean) |
---|
| Cmax | C24 | AUC |
---|
Part A-Group 1: BMS-955176 (5 mg) | 2.152 | 2.336 | 2.363 |
,Part A-Group 10: BMS-955176 (120 mg) | 1.854 | 2.063 | 2.02 |
,Part A-Group 2: BMS-955176 (10 mg) | 1.674 | 1.757 | 1.801 |
,Part A-Group 3: BMS-955176 (20 mg) | 2.018 | 2.11 | 2.289 |
,Part A-Group 4: BMS-955176 (40 mg) | 1.856 | 2.491 | 2.278 |
,Part A-Group 9: BMS-955176 (80 mg) | 2.135 | 2.385 | 2.306 |
,Part C-Group 13: BMS-955176 (120 mg) | 1.771 | 1.953 | 2.017 |
,Part C-Group 8: BMS-955176 (40 mg) | 1.966 | 2.298 | 2.337 |
[back to top]
Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C
C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose. (NCT01803074)
Timeframe: 24 hours post-dose
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 34.946 | 81.642 |
,Part A-Group 10: BMS-955176 (120 mg) | 624.745 | 1288.985 |
,Part A-Group 2: BMS-955176 (10 mg) | 79.002 | 138.775 |
,Part A-Group 3: BMS-955176 (20 mg) | 154.5 | 325.934 |
,Part A-Group 4: BMS-955176 (40 mg) | 286.268 | 713.077 |
,Part A-Group 9: BMS-955176 (80 mg) | 482.349 | 1150.397 |
,Part C-Group 13: BMS-955176 (120 mg) | 865.867 | 1691.306 |
,Part C-Group 8: BMS-955176 (40 mg) | 339.173 | 779.438 |
[back to top]
Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B
AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28
Intervention | Nanogram*hour/milliliter (Geometric Mean) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 24478.35 | 59915.72 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 12147.23 | 31406.32 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 12954.8 | 34225.08 |
[back to top]
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 24
Intervention | Cells/microliter (Mean) |
---|
| CD4+ | CD8+ |
---|
Part A-Group 1: BMS-955176 (5 mg) | -21.8 | -95 |
,Part A-Group 10: BMS-955176 (120 mg) | -56.7 | -161.3 |
,Part A-Group 2: BMS-955176 (10 mg) | 14.6 | -8.3 |
,Part A-Group 3: BMS-955176 (20 mg) | -70.1 | -107.4 |
,Part A-Group 4: BMS-955176 (40 mg) | -23.6 | -57.3 |
,Part A-Group 9: BMS-955176 (80 mg) | -43.8 | -194.6 |
,Part C-Group 13: BMS-955176 (120 mg) | 24.5 | -155.8 |
,Part C-Group 8: BMS-955176 (40 mg) | -53.7 | -214.4 |
,Placebo Clade B | -77.3 | -93.1 |
,Placebo Clade C | 18 | -136.3 |
[back to top]
Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B
Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values. (NCT01803074)
Timeframe: Baseline (Day 1) up to Day 42
Intervention | Cells/microliter (Mean) |
---|
| CD4+ | CD8+ |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | -89 | -147 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | -133.2 | -442.8 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | -106.4 | -466.1 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 33 | -216.3 |
[back to top]
Maximum Observed Plasma Concentrations (Cmax) - Part A and C
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 79.376 | 170.778 |
,Part A-Group 10: BMS-955176 (120 mg) | 1515.389 | 2809.671 |
,Part A-Group 2: BMS-955176 (10 mg) | 201.498 | 337.379 |
,Part A-Group 3: BMS-955176 (20 mg) | 349.466 | 705.073 |
,Part A-Group 4: BMS-955176 (40 mg) | 791.317 | 1476.166 |
,Part A-Group 9: BMS-955176 (80 mg) | 1155.448 | 2466.447 |
,Part C-Group 13: BMS-955176 (120 mg) | 1907.747 | 3377.967 |
,Part C-Group 8: BMS-955176 (40 mg) | 793.569 | 1560.122 |
[back to top]
[back to top]
Time to Reach Maximum Plasma Concentration (Tmax) - Part B
Tmax was directly determined from concentration time data. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28
Intervention | Hours (Median) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 5 | 4.5 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 5.01 | 4.5 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 5.05 | 5 |
[back to top]
Maximum Observed Plasma Concentrations (Cmax) - Part B
Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 28
Intervention | Nanogram/milliliter (Geometric Mean) |
---|
| Day 1 | Day 28 |
---|
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 1493.336 | 3159.181 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 695.596 | 1667.817 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 770.975 | 1852 |
[back to top]
Number of Participants With Abnormal Changes in Physical Examination
Participants with abnormal changes in physical examination is presented. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| Height | Weight | Body mass index |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 0 | 0 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 0 | 0 | 0 |
,Part A-Group 3: BMS-955176 (20 mg) | 0 | 0 | 0 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 0 | 0 | 0 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 0 | 0 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 0 | 0 | 0 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 0 | 0 | 0 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 0 | 0 | 0 |
,Placebo Clade B | 0 | 0 | 0 |
,Placebo Clade C | 0 | 0 | 0 |
[back to top]
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)
Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds [msec]): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from Baseline >30; corrected QT interval Fridericia's formula (QTcF) (msec): Value >450 or change from Baseline >30. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| PR > 200 msec | QRS > 120 msec | QT > 500 msec | QTcB > 450 msec | QTcF > 450 msec |
---|
Part A-Group 1: BMS-955176 (5 mg) | 1 | 0 | 0 | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 2 | 0 | 0 | 0 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 1 | 0 | 0 | 0 | 0 |
,Part A-Group 3: BMS-955176 (20 mg) | 1 | 0 | 0 | 0 | 1 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 | 0 | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 | 0 | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 1 | 0 | 0 | 0 | 0 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 1 | 0 | 0 | 0 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 1 | 0 | 0 | 0 | 0 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 1 | 0 | 0 | 0 | 0 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 | 0 | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 1 | 0 | 0 | 0 | 0 |
,Placebo Clade B | 0 | 0 | 0 | 0 | 0 |
,Placebo Clade C | 0 | 0 | 0 | 1 | 0 |
[back to top]
Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Systolic BP (millimeter of mercury [mmHg]): value >140 and change from Baseline >20, or value <90 and change from Baseline <-20; Diastolic BP (mmHg): value >90 and change from Baseline >10, or value <55 and change from Baseline <-10. (NCT01803074)
Timeframe: Day 1 to end of the study (Day 42)
Intervention | Participants (Count of Participants) |
---|
| SBP | DBP |
---|
Part A-Group 1: BMS-955176 (5 mg) | 0 | 0 |
,Part A-Group 10: BMS-955176 (120 mg) | 0 | 0 |
,Part A-Group 2: BMS-955176 (10 mg) | 0 | 1 |
,Part A-Group 3: BMS-955176 (20 mg) | 0 | 1 |
,Part A-Group 4: BMS-955176 (40 mg) | 0 | 0 |
,Part A-Group 9: BMS-955176 (80 mg) | 0 | 0 |
,Part B-Group 12: BMS-955176 (80 mg) + Atazanavir | 0 | 1 |
,Part B-Group 5: BMS-955176 (40 mg) + Atazanavir | 0 | 0 |
,Part B-Group 6: BMS-955176 (40 mg) + Atazanavir + Ritonavir | 1 | 1 |
,Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine | 0 | 0 |
,Part C-Group 13: BMS-955176 (120 mg) | 0 | 0 |
,Part C-Group 8: BMS-955176 (40 mg) | 0 | 1 |
,Placebo Clade B | 0 | 1 |
,Placebo Clade C | 0 | 0 |
[back to top]
Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C
Time to reach the maximum plasma concentration was directly determined from concentration time data. (NCT01803074)
Timeframe: Pre-dose Day 1 and Day 10
Intervention | Hours (Median) |
---|
| Day 1 | Day 10 |
---|
Part A-Group 1: BMS-955176 (5 mg) | 3 | 3 |
,Part A-Group 10: BMS-955176 (120 mg) | 3 | 2.5 |
,Part A-Group 2: BMS-955176 (10 mg) | 2.51 | 3 |
,Part A-Group 3: BMS-955176 (20 mg) | 3 | 4 |
,Part A-Group 4: BMS-955176 (40 mg) | 4 | 3 |
,Part A-Group 9: BMS-955176 (80 mg) | 3.5 | 3 |
,Part C-Group 13: BMS-955176 (120 mg) | 3.53 | 3 |
,Part C-Group 8: BMS-955176 (40 mg) | 3.5 | 3 |
[back to top]
Number of Participants With Self-Reported Missed Doses
self-reported missed doses (NCT01855867)
Timeframe: Day 30
Intervention | Participants (Count of Participants) |
---|
Stribild | 29 |
[back to top]
Number of Adverse Event Occurrences
The number of adverse events reported (NCT01855867)
Timeframe: 90 days
Intervention | events (Number) |
---|
| Diarrhea | Fatigue | Nausea/Vomiting | Headache | Dizziness/Lightheadness | Body Aches/Muscle and Joint Pain |
---|
Stribild | 38 | 28 | 28 | 14 | 6 | 2 |
[back to top]
nPEP Failure (HIV Infection During Study Participation)
nPEP failure, meaning HIV infection during study participation, as measured during HIV testing at day 0, day 30 and day 90 (NCT01855867)
Timeframe: 90 days
Intervention | reactive test (Number) |
---|
Stribild | 0 |
[back to top]
Change in Systemic Immune Activation
Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6). (NCT01869634)
Timeframe: Baseline, 12 months
Intervention | pg/ml (Median) |
---|
HIV Positive Naive to ART | 1.74 |
Normal Control Volunteers | 0.66 |
[back to top]
Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. (NCT01869634)
Timeframe: Baseline, 12 months
Intervention | cells / mm^2 (Median) |
---|
| Entry |
---|
Normal Control Volunteers | 478 |
[back to top]
Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV
CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. (NCT01869634)
Timeframe: Baseline, 12 months
Intervention | cells / mm^2 (Median) |
---|
| Entry | 12-months after ART |
---|
HIV Positive Naive to ART | 80 | 213 |
[back to top]
Change in Percentage of Total Artery Diameter
computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy (NCT01869634)
Timeframe: Baseline, 12 months
Intervention | % of total artery diameter (Median) |
---|
HIV Positive Naive to ART | 57 |
Normal Control Volunteers | 53 |
[back to top]
Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 4 |
[back to top]
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Log10 copies/mL (Mean) |
---|
| Baseline (Day 1), n=248, 247 | Week 4, n=245, 238 | Week 12, n=236, 226 | Week 24, n=225, 212 | Week 36, n=221, 204 | Week 48, n=207, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 4.441 | 2.516 | 1.908 | 1.710 | 1.658 | 1.657 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 4.481 | 1.895 | 1.748 | 1.724 | 1.666 | 1.619 |
[back to top]
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432
Intervention | Log10 copies/mL (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 1.591 | 1.590 |
[back to top]
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline (Day 1), n=248, 247 | Week 4, n=245, 237 | Week 12, n=236, 224 | Week 24, n=226, 210 | Week 36, n=219, 204 | Week 48, n=208, 191 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 380.3 | 455.1 | 506.2 | 542.5 | 569.2 | 608.5 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 369.7 | 465.0 | 509.5 | 563.8 | 592.8 | 608.8 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Age, <50 Years, n=212, 212 | Age, >=50 Years, n=36, 35 | Race, White, n=115, 107 | Race, Non-White, n=133,140 | Race, African-American/African Heritage, n=102,108 | Non-African-American/African Heritage, n=146, 139 | BPHR, <1000, n=5, 10 | BPHR, 1000 to <10,000, n=66, 62 | BPHR, 10,000 to <50,000, n=83, 81 | BPHR, 50,000 to <=100,000, n=25, 28 | BPHR, >100,000, n=69, 66 | BCCC, <200, n=64, 49 | BCCC, >=200, n=184, 198 | BCCC, <50, n=9, 15 | BCCC, 50 to <200, n=55, 34 | BCCC, 200 to <350, n=66, 74 | BCCC, 350 to <500, n=56, 65 | BCCC, >=500, n=62, 59 | CDC category, A, n=210, 208 | CDC category, B, n=27, 30 | CDC category, C, n=11, 9 | HIV-1 subtype: B vs Non-B, B, n=95, 111 | HIV-1 subtype: B vs Non-B, non-B, n=140, 131 | Argentina, n=24, 20 | Canada, n=11, 9 | France, n=7, 8 | Italy, n=17, 11 | Mexico, n=6, 5 | Portugal, n=4, 5 | Puerto Rico, n=0, 2 | Russia, n=28, 22 | South Africa, n=33, 33 | Spain, n=23, 31 | Thailand, n=19, 21 | USA, n=62, 69 | United Kingdom, n=14, 11 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 71 | 74 | 80 | 64 | 67 | 75 | 80 | 77 | 74 | 64 | 64 | 69 | 72 | 60 | 74 | 73 | 74 | 68 | 71 | 77 | 56 | 69 | 73 | 80 | 89 | 75 | 64 | 60 | 60 | 100 | 82 | 76 | 77 | 52 | 67 | 64 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups
Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA [BPHR], Baseline CD4+ cell count [BCCC], Baseline Centers for Disease Control and Prevention [CDC] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Age, <50 Years, n=212, 212 | Age, >=50 Years, n=36, 35 | Race, White, n=115, 107 | Race, Non-White, n=133,140 | Race, African-American/African Heritage, n=102,108 | Non-African-American/African Heritage, n=146, 139 | BPHR, <1000, n=5, 10 | BPHR, 1000 to <10,000, n=66, 62 | BPHR, 10,000 to <50,000, n=83, 81 | BPHR, 50,000 to <=100,000, n=25, 28 | BPHR, >100,000, n=69, 66 | BCCC, <200, n=64, 49 | BCCC, >=200, n=184, 198 | BCCC, <50, n=9, 15 | BCCC, 50 to <200, n=55, 34 | BCCC, 200 to <350, n=66, 74 | BCCC, 350 to <500, n=56, 65 | BCCC, >=500, n=62, 59 | CDC category, A, n=210, 208 | CDC category, B, n=27, 30 | CDC category, C, n=11, 9 | HIV-1 subtype: B vs Non-B, B, n=95, 111 | HIV-1 subtype: B vs Non-B, non-B, n=140, 131 | Argentina, n=24, 20 | Canada, n=11, 9 | France, n=7, 8 | Italy, n=17, 11 | Mexico, n=6, 5 | Portugal, n=4, 5 | Russia, n=28, 22 | South Africa, n=33, 33 | Spain, n=23, 31 | Thailand, n=19, 21 | USA, n=62, 69 | United Kingdom, n=14, 11 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 80 | 92 | 86 | 78 | 74 | 88 | 60 | 83 | 84 | 80 | 80 | 81 | 82 | 67 | 84 | 89 | 79 | 77 | 81 | 81 | 91 | 80 | 84 | 92 | 91 | 100 | 88 | 100 | 75 | 89 | 67 | 70 | 95 | 74 | 93 |
[back to top]
Change From Baseline in TC/HDL Ratio at Week 48
Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Ratio (Least Squares Mean) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.264 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.158 |
[back to top]
Change From Baseline in Triglycerides at Week 48
Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Millimoles per liter (Least Squares Mean) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.045 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.070 |
[back to top]
Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 10 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 17 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48
Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =100,000 c/mL) and CD4+ cell count (=<350 cells per millimeter cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 82 |
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 71 |
[back to top]
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Absolute values in CD4+ cell count were assessed at indicated time points. (NCT01910402)
Timeframe: Week 96 and Week 432
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 635.3 | 553.0 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <50 c/mL were reported. Percentage values are rounded off. (NCT01910402)
Timeframe: Week 96 and Week 432
Intervention | Percentage of participants (Number) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 100 | 100 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase
Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Percentage of participants (Number) |
---|
| HIV-1 RNA <50 c/mL, Baseline (Day 1) | HIV-1 RNA <50 c/mL, Week 4 | HIV-1 RNA <50 c/mL, Week 12 | HIV-1 RNA <50 c/mL, Week 24 | HIV-1 RNA <50 c/mL, Week 36 | HIV-1 RNA <50 c/mL, Week 48 | HIV-1 RNA <400 c/mL, Baseline (Day 1) | HIV-1 RNA <400 c/mL, Week 4 | HIV-1 RNA <400 c/mL, Week 12 | HIV-1 RNA <400 c/mL, Week 24 | HIV-1 RNA <400 c/mL, Week 36 | HIV-1 RNA <400 c/mL, Week 48 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0 | 13 | 49 | 77 | 77 | 71 | 1 | 54 | 84 | 82 | 81 | 76 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0 | 64 | 81 | 85 | 85 | 82 | 1 | 90 | 91 | 88 | 86 | 83 |
[back to top]
Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 432
Intervention | Participants (Count of Participants) |
---|
| INSTI; n= 6 | NNRTI; n=8 | NRTI; n=8 | PI; n=8 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD | 0 | 1 | 1 | 0 |
[back to top]
Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)
Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met. (NCT01910402)
Timeframe: Up to week 48
Intervention | Participants (Count of Participants) |
---|
| INSTI; n= 3 | NNRTI; n=4 | NRTI; n=4 | PI; n=4 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD-Randomized Phase | 1 | 0 | 1 | 0 |
[back to top]
Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 48
Intervention | Participants (Count of Participants) |
---|
| CDC Class A to CDC Class C | CDC Class B to CDC Class C | CDC Class C to new CDC Class C | CDC Class A, B or C to Death |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 4 | 2 | 0 | 1 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 5 | 1 | 0 | 1 |
[back to top]
Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)
Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. (NCT01910402)
Timeframe: Up to week 432
Intervention | Participants (Count of Participants) |
---|
| CDC Class A to CDC Class C | CDC Class B to CDC Class C | CDC Class C to new CDC Class C | CDC Class A, B or C to Death |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD | 6 | 1 | 0 | 2 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 21 | 3 | 1 | 0 | 6 | 2 | 0 | 0 | 12 | 9 | 2 | 1 | 1 | 2 | 0 | 0 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 7 | 2 | 1 | 0 | 5 | 1 | 0 | 0 | 15 | 7 | 0 | 1 | 6 | 0 | 1 | 0 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase
Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 5 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 10 | 2 | 1 | 1 | 3 | 1 | 0 | 0 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase
Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Hyperglycaemia, Grade 1 | Hyperglycaemia, Grade 2 | Hyperglycaemia, Grade 3 | Hyperglycaemia, Grade 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypoglycaemia, Grade 1 | Hypoglycaemia, Grade 2 | Hypoglycaemia, Grade 3 | Hypoglycaemia, Grade 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | Alanine aminotransferase, Grade 1 | Alanine aminotransferase, Grade 2 | Alanine aminotransferase, Grade 3 | Alanine aminotransferase, Grade 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | Alkaline phosphatase, Grade 1 | Alkaline phosphatase, Grade 2 | Alkaline phosphatase, Grade 3 | Alkaline phosphatase, Grade 4 | Aspartate aminotransferase, Grade 1 | Aspartate aminotransferase, Grade 2 | Aspartate aminotransferase, Grade 3 | Aspartate aminotransferase, Grade 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | Carbon dioxide, Grade 1 | Carbon dioxide, Grade 2 | Carbon dioxide, Grade 3 | Carbon dioxide, Grade 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | Creatine kinase, Grade 1 | Creatine kinase, Grade 2 | Creatine kinase, Grade 3 | Creatine kinase, Grade 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | LDL cholesterol calculation, Grade 1 | LDL cholesterol calculation, Grade 2 | LDL cholesterol calculation, Grade 3 | LDL cholesterol calculation, Grade 4 | LDL cholesterol direct, Grade 1 | LDL cholesterol direct, Grade 2 | LDL cholesterol direct, Grade 3 | LDL cholesterol direct, Grade 4 | Lipase, Grade 1 | Lipase, Grade 2 | Lipase, Grade 3 | Lipase, Grade 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Potassium, Grade 1 | Potassium, Grade 2 | Potassium, Grade 3 | Potassium, Grade 4 | Sodium, Grade 1 | Sodium, Grade 2 | Sodium, Grade 3 | Sodium, Grade 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 | Glucose, Grade 1 | Glucose, Grade 2 | Glucose, Grade 3 | Glucose, Grade 4 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 11 | 9 | 3 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 0 | 19 | 0 | 0 | 0 | 57 | 0 | 0 | 0 | 7 | 4 | 2 | 0 | 2 | 2 | 0 | 0 | 14 | 1 | 0 | 0 | 7 | 4 | 2 | 0 | 52 | 86 | 57 | 5 | 54 | 3 | 0 | 0 | 31 | 9 | 2 | 0 | 5 | 1 | 0 | 1 | 7 | 3 | 0 | 0 | 21 | 9 | 2 | 0 | 1 | 0 | 0 | 0 | 7 | 3 | 2 | 1 | 11 | 9 | 2 | 0 | 19 | 1 | 0 | 0 | 57 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 15 | 10 | 3 | 0 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 17 | 16 | 4 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 3 | 1 | 0 | 17 | 1 | 0 | 0 | 44 | 1 | 0 | 0 | 5 | 6 | 1 | 1 | 3 | 0 | 0 | 0 | 3 | 2 | 0 | 0 | 12 | 4 | 1 | 1 | 2 | 0 | 0 | 0 | 65 | 4 | 0 | 0 | 52 | 28 | 4 | 0 | 3 | 1 | 3 | 0 | 3 | 0 | 1 | 0 | 38 | 13 | 7 | 0 | 3 | 1 | 0 | 0 | 12 | 5 | 3 | 0 | 5 | 7 | 1 | 0 | 18 | 1 | 0 | 0 | 45 | 1 | 0 | 0 | 0 | 5 | 2 | 0 | 22 | 19 | 4 | 1 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase
Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Hyperglycaemia, Grade 1, n=143 | Hyperglycaemia, Grade 2, n=143 | Hyperglycaemia, Grade 3, n=143 | Hyperglycaemia, Grade 4, n=143 | Hypernatremia, Grade 1, n=146 | Hypernatremia, Grade 2, n=146 | Hypernatremia, Grade 3, n=146 | Hypernatremia, Grade 4, n=146 | Hypoglycaemia, Grade 1, n=143 | Hypoglycaemia, Grade 2, n=143 | Hypoglycaemia, Grade 3, n=143 | Hypoglycaemia, Grade 4, n=143 | Hypokalemia, Grade 1, n=146 | Hypokalemia, Grade 2, n=146 | Hypokalemia, Grade 3, n=146 | Hypokalemia, Grade 4, n=146 | Hyponatremia, Grade 1, n=146 | Hyponatremia, Grade 2, n=146 | Hyponatremia, Grade 3, n=146 | Hyponatremia, Grade 4, n=146 | Alanine aminotransferase, Grade 1, n=146 | Alanine aminotransferase, Grade 2, n=146 | Alanine aminotransferase, Grade 3, n=146 | Alanine aminotransferase, Grade 4, n=146 | Alkaline phosphatase, Grade 1, n=146 | Alkaline phosphatase, Grade 2, n=146 | Alkaline phosphatase, Grade 3, n=146 | Alkaline phosphatase, Grade 4, n=146 | Aspartate aminotransferase, Grade 1, n=146 | Aspartate aminotransferase, Grade 2, n=146 | Aspartate aminotransferase, Grade 3, n=146 | Aspartate aminotransferase, Grade 4, n=146 | Bilirubin, Grade 1, n=146 | Bilirubin, Grade 2, n=146 | Bilirubin, Grade 3, n=146 | Bilirubin, Grade 4, n=146 | Carbon dioxide, Grade 1, n=146 | Carbon dioxide, Grade 2, n=146 | Carbon dioxide, Grade 3, n=146 | Carbon dioxide, Grade 4, n=146 | Cholesterol, Grade 1, n=71 | Cholesterol, Grade 2, n=71 | Cholesterol, Grade 3, n=71 | Cholesterol, Grade 4, n=71 | Creatine kinase, Grade 1, n=146 | Creatine kinase, Grade 2, n=146 | Creatine kinase, Grade 3, n=146 | Creatine kinase, Grade 4, n=146 | Creatinine, Grade 1, n=146 | Creatinine, Grade 2, n=146 | Creatinine, Grade 3, n=146 | Creatinine, Grade 4, n=146 | LDL cholesterol calculation, Grade 1, n=70 | LDL cholesterol calculation, Grade 2, n=70 | LDL cholesterol calculation, Grade 3, n=70 | LDL cholesterol calculation, Grade 4, n=70 | LDL cholesterol direct, Grade 1, n=2 | LDL cholesterol direct, Grade 2, n=2 | LDL cholesterol direct, Grade 3, n=2 | LDL cholesterol direct, Grade 4, n=2 | Lipase, Grade 1, n=146 | Lipase, Grade 2, n=146 | Lipase, Grade 3, n=146 | Lipase, Grade 4, n=146 | Phosphate, Grade 1, n=146 | Phosphate, Grade 2, n=146 | Phosphate, Grade 3, n=146 | Phosphate, Grade 4, n=146 | Potassium, Grade 1, n=146 | Potassium, Grade 2, n=146 | Potassium, Grade 3, n=146 | Potassium, Grade 4, n=146 | Sodium, Grade 1, n=146 | Sodium, Grade 2, n=146 | Sodium, Grade 3, n=146 | Sodium, Grade 4, n=146 | Triglycerides, Grade 1, n=71 | Triglycerides, Grade 2, n=71 | Triglycerides, Grade 3, n=71 | Triglycerides, Grade 4, n=71 | Glucose, Grade 1, n=143 | Glucose, Grade 2, n=143 | Glucose, Grade 3, n=143 | Glucose, Grade 4, n=143 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 24 | 9 | 3 | 0 | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 13 | 0 | 0 | 0 | 36 | 0 | 0 | 0 | 7 | 3 | 0 | 2 | 5 | 0 | 0 | 0 | 10 | 2 | 0 | 2 | 4 | 1 | 3 | 0 | 58 | 7 | 0 | 0 | 9 | 9 | 3 | 0 | 6 | 1 | 1 | 1 | 5 | 0 | 0 | 1 | 5 | 8 | 2 | 0 | 1 | 0 | 0 | 0 | 9 | 6 | 1 | 1 | 2 | 15 | 2 | 0 | 13 | 0 | 0 | 0 | 37 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 24 | 9 | 3 | 1 |
[back to top]
Number of Participants With Any AEs, and SAEs in Continuation Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Any AEs | Any SAEs |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 93 | 13 |
[back to top]
Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Any AEs | Any SAEs |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 197 | 20 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 195 | 12 |
[back to top]
Number of Participants With AEs by Maximum Toxicity-Randomized Phase
Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: Up to Week 48
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 60 | 91 | 37 | 9 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 79 | 94 | 18 | 3 |
[back to top]
Number of Participants With AEs by Maximum Toxicity-Continuation Phase
Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. (NCT01910402)
Timeframe: From Weeks 48 to 432
Intervention | Participants (Count of Participants) |
---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 32 | 48 | 7 | 6 |
[back to top]
HIVTSQs Total Score at Indicated Timepoints
The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. (NCT01910402)
Timeframe: Weeks 4, 12, 24 and 48
Intervention | Score on a scale (Mean) |
---|
| Week 4, n=243, 239 | Week 12, n=236, 226 | Week 24, n=225, 211 | Week 48, n=206, 191 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 51.9 | 53.6 | 54.3 | 55.4 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 54.0 | 56.1 | 56.8 | 57.0 |
[back to top]
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48
Intervention | Nanomoles per liter (Mean) |
---|
| Vitamin D, Week 24, n=223, 208 | Vitamin D, Week 48, n=206, 186 | Vitamin D2, Week 24, n=223, 208 | Vitamin D2, Week 48, n=206, 186 | Vitamin D3, Week 24, n=223, 208 | Vitamin D3, Week 48, n=206, 186 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 16.3 | 8.9 | 1.0 | 0.9 | 15.2 | 7.9 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 1.8 | -1.9 | 0.3 | 0.1 | 1.5 | -1.9 |
[back to top]
Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points
Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 24 and Week 48
Intervention | milligrams per millimole (Mean) |
---|
| Week 24, n= 179, 186 | Week 48, n= 170, 164 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -1.03 | -0.10 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -1.15 | -0.68 |
[back to top]
Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48
Intervention | Nanograms per liter (Mean) |
---|
| Week 24, n=221, 207 | Week 48, n=202, 185 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 272.4 | 267.9 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 89.8 | 75.9 |
[back to top]
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Ratio (Mean) |
---|
| Week 4, n= 1, 4 | Week 12, n= 233, 223 | Week 24, n= 224, 209 | Week 36, n= 212, 198 | Week 48, n= 207, 186 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.2159 | -0.1092 | -0.1922 | -0.1433 | -0.1444 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.1264 | -0.2736 | -0.3098 | -0.3286 | -0.2886 |
[back to top]
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Log10 copies/mL (Mean) |
---|
| Week 4, n=245, 238 | Week 12, n=236, 226 | Week 24, n=225, 212 | Week 36, n=221, 204 | Week 48, n=207, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -1.923 | -2.541 | -2.726 | -2.772 | -2.752 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -2.591 | -2.756 | -2.789 | -2.838 | -2.874 |
[back to top]
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase
Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96 and Week 432
Intervention | Log10 copies/mL (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | -2.911 | -3.107 |
[back to top]
Change From Baseline in Hematocrit Count at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Week 4, n= 243, 234 | Week 12, n= 233, 220 | Week 24, n= 225, 211 | Week 36, n= 218, 203 | Week 48, n= 207, 190 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.0042 | 0.0000 | 0.0051 | 0.0062 | 0.0107 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.0003 | 0.0081 | 0.0157 | 0.0167 | 0.0212 |
[back to top]
Change From Baseline in Erythrocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | 10^12 cells per liter (Mean) |
---|
| Week 4, n= 243, 234 | Week 12, n= 233, 220 | Week 24, n= 225, 211 | Week 36, n= 218, 203 | Week 48, n= 207, 190 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.07 | -0.09 | -0.09 | -0.08 | -0.05 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.04 | -0.07 | -0.08 | -0.10 | -0.10 |
[back to top]
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Femtoliter (Mean) |
---|
| Week 4, n= 243, 234 | Week 12, n= 233, 220 | Week 24, n= 225, 211 | Week 36, n= 218, 203 | Week 48, n= 207, 190 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.5 | 1.9 | 3.1 | 3.1 | 3.7 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.9 | 3.4 | 5.5 | 6.0 | 7.1 |
[back to top]
Change From Baseline in Creatinine Clearance at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Milliliter per minute (Mean) |
---|
| Week 4, n= 245, 237 | Week 12, n= 236, 226 | Week 24, n= 225, 212 | Week 36, n= 219, 204 | Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -7.5 | -7 | -9.1 | -7.5 | -7.7 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -16.3 | -17.3 | -16.2 | -16.8 | -15.9 |
[back to top]
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase
Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 4, n=245, 237 | Week 12, n=236, 224 | Week 24, n=226, 210 | Week 36, n=219, 204 | Week 48, n=208, 191 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 73.7 | 124.4 | 163.0 | 191.4 | 230.7 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 94.9 | 143.8 | 200.6 | 230.7 | 248.8 |
[back to top]
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase
Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 96, Week 432
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 96, n=99 | Week 432, n=3 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase | 286.5 | 254.7 |
[back to top]
Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Millimoles per liter (Mean) |
---|
| Carbon Dioxide, Week 4, n= 244, 237 | Carbon Dioxide, Week 12, n= 236, 226 | Carbon Dioxide, Week 24, n= 224, 212 | Carbon Dioxide, Week 36, n= 219, 204 | Carbon Dioxide, Week 48, n= 208, 192 | Chloride, Week 4, n= 245, 237 | Chloride, Week 12, n= 236, 226 | Chloride, Week 24, n= 225, 212 | Chloride, Week 36, n= 219, 204 | Chloride, Week 48, n= 208, 192 | CHLS, Week 4, n= 1, 3 | CHLS, Week 12, n= 224, 221 | CHLS, Week 24, n= 218, 201 | CHLS, Week 36, n= 205, 191 | CHLS, Week 48, n= 195, 175 | Glucose, Week 12, n= 226, 224 | Glucose, Week 24, n= 219, 204 | Glucose, Week 36, n= 211, 196 | Glucose, Week 48, n= 197, 180 | HDL CHLS, Direct, Week 4, n= 1, 3 | HDL CHLS, Direct, Week 12, n= 224, 221 | HDL CHLS, Direct, Week 24, n= 218, 201 | HDL CHLS, Direct, Week 36, n= 205, 191 | HDL CHLS, Direct, Week 48, n= 195, 175 | Hyperglycaemia, Week 12, n= 226, 224 | Hyperglycaemia, Week 24, n= 219, 204 | Hyperglycaemia, Week 36, n= 211, 196 | Hyperglycaemia, Week 48, n= 197, 180 | Hyperkalemia, Week 4, n= 244, 237 | Hyperkalemia, Week 12, n= 236, 226 | Hyperkalemia, Week 24, n= 224, 212 | Hyperkalemia, Week 36, n= 219, 204 | Hyperkalemia, Week 48, n= 208, 192 | Hypernatremia, Week 4, n= 245, 237 | Hypernatremia, Week 12, n= 236, 226 | Hypernatremia, Week 24, n= 225, 212 | Hypernatremia, Week 36, n= 219, 204 | Hypernatremia, Week 48, n= 208, 192 | Hypoglycaemia, Week 12, n= 226, 224 | Hypoglycaemia, Week 24, n= 219, 204 | Hypoglycaemia, Week 36, n= 211, 196 | Hypoglycaemia, Week 48, n= 197, 180 | Hypokalemia, Week 4, n= 244, 237 | Hypokalemia, Week 12, n= 236, 226 | Hypokalemia, Week 24, n= 224, 212 | Hypokalemia, Week 36, n= 219, 204 | Hypokalemia, Week 48, n= 208, 192 | Hyponatremia, Week 4, n= 245, 237 | Hyponatremia, Week 12, n= 236, 226 | Hyponatremia, Week 24, n= 225, 212 | Hyponatremia, Week 36, n= 219, 204 | Hyponatremia, Week 48, n= 208, 192 | LDL CHLS Calculation, Week 4, n= 1, 3 | LDL CHLS Calculation, Week 12, n= 221, 219 | LDL CHLS Calculation, Week 24, n= 213, 201 | LDL CHLS Calculation, Week 36, n= 201, 188 | LDL CHLS Calculation, Week 48, n= 190, 175 | LDL CHLS, Direct, Week 24, n= 1, 0 | LDL CHLS, Direct, Week 36, n= 1, 0 | Phosphate, Week 4, n= 245, 237 | Phosphate, Week 12, n= 236, 226 | Phosphate, Week 24, n= 225, 212 | Phosphate, Week 36, n= 219, 204 | Phosphate, Week 48, n= 208, 192 | Potassium, Week 4, n= 244, 237 | Potassium, Week 12, n= 236, 226 | Potassium, Week 24, n= 224, 212 | Potassium, Week 36, n= 219, 204 | Potassium, Week 48, n= 208, 192 | Sodium, Week 4, n= 245, 237 | Sodium, Week 12, n= 236, 226 | Sodium, Week 24, n= 225, 212 | Sodium, Week 36, n= 219, 204 | Sodium, Week 48, n= 208, 192 | Triglycerides, Week 4, n= 1, 3 | Triglycerides, Week 12, n= 224, 221 | Triglycerides, Week 24, n= 218, 201 | Triglycerides, Week 36, n= 205, 191 | Triglycerides, Week 48, n= 195, 175 | Urea, Week 4, n= 245, 237 | Urea, Week 12, n= 236, 226 | Urea, Week 24, n= 225, 212 | Urea, Week 36, n= 219, 204 | Urea, Week 48, n= 208, 192 |
---|
DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.4 | -0.2 | -0.5 | 0 | -0.6 | 0.6 | 1 | 0.7 | 0.9 | 0.7 | -0.1 | 0.298 | 0.317 | 0.33 | 0.447 | 0.3 | 0.17 | 0.17 | 0.18 | -0.1 | 0.182 | 0.201 | 0.204 | 0.231 | 0.3 | 0.17 | 0.17 | 0.18 | -0.01 | 0.03 | -0.04 | 0.03 | -0.04 | 0 | 0.7 | 0.6 | 0.9 | 0.6 | 0.3 | 0.17 | 0.17 | 0.18 | -0.01 | 0.03 | -0.04 | 0.03 | -0.04 | 0 | 0.7 | 0.6 | 0.9 | 0.6 | 0.08 | 0.125 | 0.111 | 0.112 | 0.213 | -0.64 | -0.23 | 0 | 0.02 | 0.021 | 0.029 | 0.016 | -0.01 | 0.03 | -0.04 | 0.03 | -0.04 | 0 | 0.7 | 0.6 | 0.9 | 0.6 | -0.18 | -0.04 | 0.036 | 0.037 | 0.018 | -0.04 | 0.08 | 0.03 | 0.08 | 0.1 |
[back to top]
Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Millimoles per liter (Mean) |
---|
| Carbon Dioxide, Week 4, n= 244, 237 | Carbon Dioxide, Week 12, n= 236, 226 | Carbon Dioxide, Week 24, n= 224, 212 | Carbon Dioxide, Week 36, n= 219, 204 | Carbon Dioxide, Week 48, n= 208, 192 | Chloride, Week 4, n= 245, 237 | Chloride, Week 12, n= 236, 226 | Chloride, Week 24, n= 225, 212 | Chloride, Week 36, n= 219, 204 | Chloride, Week 48, n= 208, 192 | CHLS, Week 4, n= 1, 3 | CHLS, Week 12, n= 224, 221 | CHLS, Week 24, n= 218, 201 | CHLS, Week 36, n= 205, 191 | CHLS, Week 48, n= 195, 175 | Glucose, Week 12, n= 226, 224 | Glucose, Week 24, n= 219, 204 | Glucose, Week 36, n= 211, 196 | Glucose, Week 48, n= 197, 180 | HDL CHLS, Direct, Week 4, n= 1, 3 | HDL CHLS, Direct, Week 12, n= 224, 221 | HDL CHLS, Direct, Week 24, n= 218, 201 | HDL CHLS, Direct, Week 36, n= 205, 191 | HDL CHLS, Direct, Week 48, n= 195, 175 | Hyperglycaemia, Week 12, n= 226, 224 | Hyperglycaemia, Week 24, n= 219, 204 | Hyperglycaemia, Week 36, n= 211, 196 | Hyperglycaemia, Week 48, n= 197, 180 | Hyperkalemia, Week 4, n= 244, 237 | Hyperkalemia, Week 12, n= 236, 226 | Hyperkalemia, Week 24, n= 224, 212 | Hyperkalemia, Week 36, n= 219, 204 | Hyperkalemia, Week 48, n= 208, 192 | Hypernatremia, Week 4, n= 245, 237 | Hypernatremia, Week 12, n= 236, 226 | Hypernatremia, Week 24, n= 225, 212 | Hypernatremia, Week 36, n= 219, 204 | Hypernatremia, Week 48, n= 208, 192 | Hypoglycaemia, Week 12, n= 226, 224 | Hypoglycaemia, Week 24, n= 219, 204 | Hypoglycaemia, Week 36, n= 211, 196 | Hypoglycaemia, Week 48, n= 197, 180 | Hypokalemia, Week 4, n= 244, 237 | Hypokalemia, Week 12, n= 236, 226 | Hypokalemia, Week 24, n= 224, 212 | Hypokalemia, Week 36, n= 219, 204 | Hypokalemia, Week 48, n= 208, 192 | Hyponatremia, Week 4, n= 245, 237 | Hyponatremia, Week 12, n= 236, 226 | Hyponatremia, Week 24, n= 225, 212 | Hyponatremia, Week 36, n= 219, 204 | Hyponatremia, Week 48, n= 208, 192 | LDL CHLS Calculation, Week 4, n= 1, 3 | LDL CHLS Calculation, Week 12, n= 221, 219 | LDL CHLS Calculation, Week 24, n= 213, 201 | LDL CHLS Calculation, Week 36, n= 201, 188 | LDL CHLS Calculation, Week 48, n= 190, 175 | LDL CHLS, Direct, Week 12, n= 0, 1 | Phosphate, Week 4, n= 245, 237 | Phosphate, Week 12, n= 236, 226 | Phosphate, Week 24, n= 225, 212 | Phosphate, Week 36, n= 219, 204 | Phosphate, Week 48, n= 208, 192 | Potassium, Week 4, n= 244, 237 | Potassium, Week 12, n= 236, 226 | Potassium, Week 24, n= 224, 212 | Potassium, Week 36, n= 219, 204 | Potassium, Week 48, n= 208, 192 | Sodium, Week 4, n= 245, 237 | Sodium, Week 12, n= 236, 226 | Sodium, Week 24, n= 225, 212 | Sodium, Week 36, n= 219, 204 | Sodium, Week 48, n= 208, 192 | Triglycerides, Week 4, n= 1, 3 | Triglycerides, Week 12, n= 224, 221 | Triglycerides, Week 24, n= 218, 201 | Triglycerides, Week 36, n= 205, 191 | Triglycerides, Week 48, n= 195, 175 | Urea, Week 4, n= 245, 237 | Urea, Week 12, n= 236, 226 | Urea, Week 24, n= 225, 212 | Urea, Week 36, n= 219, 204 | Urea, Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.6 | 0.8 | 0.3 | 0.6 | 0.4 | -0.5 | 0.2 | -0.1 | 0 | 0 | -0.017 | -0.058 | -0.001 | 0 | 0.109 | 0.22 | 0.26 | 0.34 | 0.24 | 0 | 0.005 | 0.053 | 0.036 | 0.081 | 0.22 | 0.26 | 0.34 | 0.24 | 0.12 | 0.1 | 0.06 | 0.13 | 0.04 | -0.5 | 0.1 | 0.2 | 0.2 | 0.5 | 0.22 | 0.26 | 0.34 | 0.24 | 0.12 | 0.1 | 0.06 | 0.13 | 0.04 | -0.5 | 0.1 | 0.2 | 0.2 | 0.5 | -0.123 | -0.14 | -0.111 | -0.099 | -0.021 | -0.44 | -0.032 | 0.026 | 0.026 | 0.009 | 0 | 0.12 | 0.1 | 0.06 | 0.13 | 0.04 | -0.5 | 0.1 | 0.2 | 0.2 | 0.5 | 0.237 | 0.167 | 0.125 | 0.157 | 0.107 | 0.1 | 0.16 | 0.12 | -0.03 | 0.02 |
[back to top]
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints
Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Weeks 24 and 48
Intervention | Micrograms per liter (Mean) |
---|
| BSAP, Week 24, n=219, 207 | BSAP, Week 48, n=202, 184 | Osteocalcin, Week 24, n=209, 197 | Osteocalcin, Week 48, n=194, 178 | PTP, Week 24, n=223, 206 | PTP, Week 48, n=205, 186 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 6.00 | 7.60 | 14.38 | 16.30 | 32.0 | 34.1 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 1.33 | 2.64 | 3.73 | 5.15 | 10.1 | 11.2 |
[back to top]
Change From Baseline in Lipase at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Units per liter (Mean) |
---|
| Week 4, n= 245, 237 | Week 12, n= 236, 226 | Week 24, n= 225, 212 | Week 36, n= 219, 204 | Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -1.3 | -2.1 | -6 | -6.3 | -7.8 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -1.2 | -2.2 | -6 | -6.3 | -6.5 |
[back to top]
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Micromoles per liter (Mean) |
---|
| Bilirubin, Week 4, n= 244, 237 | Bilirubin, Week 12, n= 236, 226 | Bilirubin, Week 24, n= 225, 212 | Bilirubin, Week 36, n= 219, 204 | Bilirubin, Week 48, n= 208, 192 | Creatinine, Week 4, n= 245, 237 | Creatinine, Week 12, n= 236, 226 | Creatinine, Week 24, n= 225, 212 | Creatinine, Week 36, n= 219, 204 | Creatinine, Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 27.2 | 22.8 | 25 | 23.8 | 23.7 | 4.89 | 5.83 | 5.8 | 5.37 | 5.86 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -0.8 | -0.6 | -0.2 | -0.2 | -0.3 | 8.4 | 9.2 | 9.16 | 10.08 | 9.29 |
[back to top]
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points
Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | 10^9 cells per liter (Mean) |
---|
| Basophils, Week 4, n= 241, 234 | Basophils, Week 12, n= 228, 216 | Basophils, Week 24, n= 221, 208 | Basophils, Week 36, n= 214, 203 | Basophils, Week 48, n= 206, 189 | Eosinophils, Week 4, n= 241, 234 | Eosinophils, Week 12, n= 228, 216 | Eosinophils, Week 24, n= 221, 208 | Eosinophils, Week 36, n= 214, 203 | Eosinophils, Week 48, n= 206, 189 | Lymphocytes, Week 4, n= 241, 234 | Lymphocytes, Week 12, n= 228, 216 | Lymphocytes, Week 24, n= 221, 208 | Lymphocytes, Week 36, n= 214, 203 | Lymphocytes, Week 48, n= 206, 189 | Monocytes, Week 4, n= 241, 234 | Monocytes, Week 12, n= 228, 216 | Monocytes, Week 24, n= 221, 208 | Monocytes, Week 36, n= 214, 203 | Monocytes, Week 48, n= 206, 189 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.003 | 0.003 | 0.003 | 0.003 | 0.006 | 0.021 | -0.001 | 0.005 | 0.014 | 0.007 | 0.119 | 0.156 | 0.192 | 0.178 | 0.261 | -0.015 | -0.031 | -0.015 | -0.028 | -0.024 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.003 | 0.002 | 0.004 | 0.004 | 0.005 | 0.040 | 0.037 | 0.028 | 0.048 | 0.030 | 0.208 | 0.257 | 0.317 | 0.362 | 0.359 | -0.001 | -0.010 | 0.008 | -0.006 | 0.001 |
[back to top]
Change From Baseline in Albumin at Indicated Timepoints
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | Grams per liter (Mean) |
---|
| Week 4, n= 245, 237 | Week 12, n= 236, 226 | Week 24, n= 225, 212 | Week 36, n= 219, 204 | Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -0.5 | 0.1 | 0.8 | 0.6 | 1.3 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.1 | 0.5 | 1.4 | 1.4 | 1.7 |
[back to top]
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points
Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
Intervention | International units per liter (Mean) |
---|
| Alanine aminotransferase, Week 4, n= 245, 237 | Alanine aminotransferase, Week 12, n= 236, 226 | Alanine aminotransferase, Week 24, n= 225, 212 | Alanine aminotransferase, Week 36, n= 219, 204 | Alanine aminotransferase, Week 48, n= 208, 192 | Alkaline phosphatase, Week 4, n= 245, 237 | Alkaline phosphatase, Week 12, n= 236, 226 | Alkaline phosphatase, Week 24, n= 225, 212 | Alkaline phosphatase, Week 36, n= 219, 204 | Alkaline phosphatase, Week 48, n= 208, 192 | Aspartate aminotransferase, Week 4, n= 244, 237 | Aspartate aminotransferase, Week 12, n= 236, 226 | Aspartate aminotransferase, Week 24, n= 224, 212 | Aspartate aminotransferase, Week 36, n= 219, 204 | Aspartate aminotransferase, Week 48, n= 208, 192 | Creatine Kinase, Week 4, n= 245, 237 | Creatine Kinase, Week 12, n= 236, 226 | Creatine Kinase, Week 24, n= 225, 212 | Creatine Kinase, Week 36, n= 219, 204 | Creatine Kinase, Week 48, n= 208, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | -3.4 | -2.3 | -3.7 | -5.3 | -1.5 | 9.4 | 15.1 | 22.4 | 20.4 | 21.9 | -3.6 | -4 | -5.1 | -6.5 | -3.7 | 35.6 | 7.3 | 5.8 | 7.2 | 3.8 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | -3.3 | -5.2 | -5.4 | -4.9 | -5.7 | -1.5 | -2.1 | 0.5 | 0.6 | 2.9 | -3.3 | -6.2 | -6.3 | -6.4 | -7.5 | -0.3 | 6.9 | 10.3 | 11.9 | 23.8 |
[back to top]
Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS
The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Score on a scale (Mean) |
---|
| Total Score, Week 48, n=205, 192 | MCS, Week 48, n=205, 192 | PCS, Week 48, n=205, 192 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 0.1 | 2.329 | 1.444 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 0.0 | 2.397 | 1.905 |
[back to top]
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline
Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. (NCT01910402)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Ratio (Number) |
---|
| BSAP, n=202, 183 | PTP, n=202, 184 | Osteocalcin, n=194, 178 | Type 1 Collagen C-Telopeptide, n=202, 184 | Vitamin D, n=206, 186 |
---|
ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase | 1.629 | 1.752 | 2.039 | 1.918 | 1.158 |
,DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase | 1.188 | 1.214 | 1.282 | 1.257 | 0.987 |
[back to top]
[back to top]
[back to top]
[back to top]
Fasting Lipid Profile
Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen. (NCT01929759)
Timeframe: 8 weeks
Intervention | mg/dl (Mean) |
---|
| pre-switch Total cholesterol | post-switch Total cholesterol | pre-switch HDL | post-switch HDL | pre-switch LDL | post-switch LDL | pre-switch triglyceride | post-switch triglyceride |
---|
Drug Switching | 178.8 | 168.5 | 52.6 | 52.3 | 106.1 | 97.4 | 101.3 | 94.5 |
[back to top]
Sleep Quality
Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality; minimum Score = 0 (better); maximum Score = 21 (worse). (NCT01929759)
Timeframe: week 0 and week 8
Intervention | units on a scale (Mean) |
---|
| pre-switch PSQI index | post-switch PSQI index |
---|
Drug Switching | 4.8 | 3.1 |
[back to top]
Neurocognitive Changes
"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain damage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~6. Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80." (NCT01929759)
Timeframe: week 0 and week 8
Intervention | units on a scale (Mean) |
---|
| pre-switch WAIS | post-switch WAIS | pre-switch FRSBE | post-switch FRSBE | pre-switch HAMD | post-switch HAMD | pre-switch DASS depression | post-switch DASS depression | pre-swtich STAI | post-switch STAI |
---|
Drug Switching | 49.3 | 53.4 | 77.5 | 70.4 | 5.5 | 2.8 | 7.6 | 3.4 | 28.8 | 24.2 |
[back to top]
Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)
Assess changes in neural activation correlated with affective disturbances associated with efavirenz-based therapy using fMRI employing an Emotional Word/Go-NoGo task paradigm that probes affective symptomatologies typical with EFV use, specifically anxiety/dysphoria and affective dysregulation and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-switch / Post-switch / Pre- vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect and Age incorporated as a co-variate of no interest. (NCT01929759)
Timeframe: week 0 and week 8
Intervention | z-score (Number) |
---|
| PreVsPostXNegVsNeuXNoGoVsGo: aFP | PreVsPostXNegVsNeuXNoGoVsGo: pCG | PreVsPostXNegVsNeuXNoGoVsGo: daCG | PreVsPostXNegVsNeuXNoGoVsGo:LHC | Pre: NegVsNeuXNoGoVsGo: aFP | Pre: NegVsNeuXNoGoVsGo:pCG | Pre: NegVsNeuXNoGoVsGo: daCG | Pre: NegVsNeuXNoGoVsGo: LHC | Post: NegVsNeuXNoGoVsGo: aFP | Post: NegVsNeuXNoGoVsGo: pCG | Post: NegVsNeuXNoGoVsGo: daCG | Post: NegVsNeuXNoGoVsGo: LHC |
---|
Drug Switching | 3.42 | 3.90 | -2.76 | -2.96 | 3.39 | 3.61 | -3.15 | -2.27 | -3.17 | -2.66 | 3.69 | 3.47 |
[back to top]
Markers of Immune Activation
Change in markers of immune activation and inflammation associated with change to Stibild: sCD14, IP-10,sCD163, IL-6) (NCT01929759)
Timeframe: week 0 and week 8
Intervention | pg/ML (Mean) |
---|
| pre-switch sCD14 | post-switch sCD14 | pre-switch IP-10 | post-switch IP-10 | pre-switch sCD163 | post-switch sCD163 | pre-switch MCP-1 | post-switch MCP-1 | pre-switch IL-6 | post-switch IL-6 | pre-switch TNFR1 | post-switch TNFR1 |
---|
Drug Switching | 3329000 | 2879000 | 237.3 | 224.2 | 732000 | 599500 | 102.2 | 91.39 | 1.255 | 1.301 | 833.2 | 878.1 |
[back to top]
Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada
TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing. (NCT02022657)
Timeframe: Assessed every 2 weeks during the dosing periods and at steady-state, week 12 for the first dosing period and week 36 for the second dosing period.
Intervention | fmol/punch (Mean) |
---|
DOT-DBS Dosing 33% | 530 |
DOT-DBS Dosing 67% | 997 |
DOT-DBS Dosing 100% | 1605 |
[back to top]
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^-0.858 × [age]-0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^-0.293 × [urine urea nitrogen excretion (g/d)]^0.249. (NCT02116660)
Timeframe: Baseline and Week 48
Intervention | mL/min (Mean) |
---|
Raltegravir Plus Nevirapine Plus Lamivudine | -1.1 |
Protease Inhibitor/Ritonavir Plus Tenofovir/Emtricitabine | -5.5 |
[back to top]
Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events
(NCT02180438)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
Grade 3 or 4 Adverse Events
Adverse event per NIH/DAIDS criteria (NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| Lab: Grade 3 or 4 | Clinical: Grade 3 or 4 |
---|
Open Label Prospective Single Arm Study of Stribild | 7 | 1 |
[back to top]
Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
| >50 copies/mL | >400 copies/mL |
---|
Open Label Prospective Single Arm Study of Stribild | 1 | 0 |
[back to top]
Switching Off Stribild Prior to 48 Weeks
(NCT02180438)
Timeframe: 48 Weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
Death
Number of Participants Experiencing Death within the study period (NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
New WHO Stage 3 or 4 Event
New AIDS defining event per WHO criteria (NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event
(NCT02180438)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
Interim Analysis at 24 Weeks of HIV-2 Virologic Failure
Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml) (NCT02180438)
Timeframe: 24 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
Interim 24 Weeks Analysis of Death
(NCT02180438)
Timeframe: 24 weeks
Intervention | participants (Number) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 1 |
[back to top]
CD4 T-cell Count at 48 Weeks < Baseline
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 0 |
[back to top]
< 50 CD4 T-cell Increase at 48 Weeks From Baseline
(NCT02180438)
Timeframe: 48 weeks
Intervention | Participants (Count of Participants) |
---|
Open Label Prospective Single Arm Study of Stribild | 2 |
[back to top]
Reported Alcohol and Substance Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires at the Enrolment Visit
Reported substance use and alcohol use as evidenced by participant responses to interviewer-administered questionnaires (NCT02213328)
Timeframe: Baseline visit
Intervention | Participants (Count of Participants) |
---|
| No. of participants reporting alcohol use | No. of participants reporting drug use |
---|
Truvada | 83 | 25 |
[back to top]
Number of Participants With Grades 2, 3, and 4 Clinical and Laboratory Adverse Events
Assessment of Grades 2, 3, and 4 clinical and laboratory adverse events measured through week 48 using the DAIDS table for grading adult and paediatric adverse events, dated Dec 2004, (clarification Aug 2009). Expedited Adverse Event (EAE) reporting followed standard reporting requirements as defined in the DAIDS Manual for Expedited Reporting of Adverse Events version 2·0, March 2011. (NCT02213328)
Timeframe: Measured through Week 48
Intervention | Participants (Count of Participants) |
---|
| Grade 2 | Grade 3 | Grade 4 |
---|
Truvada | 14 | 4 | 2 |
[back to top]
Number of Adolescents Who Continue to Use PrEP (as Indicated by Dried Blood Spot [DBS] Levels) After the Initial 3-month Period
Number of adolescents who continued to use PrEP (as indicated by dried blood spot level) after the initial 3-month period as indicated by DBS at week 24/36/48 (NCT02213328)
Timeframe: Measured through Week 48
Intervention | Participants (Count of Participants) |
---|
| Participants with truvada in DBS at week 24 | Participants with truvada in DBS at week 36 | Participants with truvada in DBS at week 48 |
---|
Truvada | 74 | 31 | 22 |
[back to top]
Proportion of Adolescents With Detectable Drug Levels Who Report Using PrEP
Proportion of adolescents with detectable drug levels who report using PrEP at weeks 12,24,36,48 (NCT02213328)
Timeframe: Measured though Week 48
Intervention | Participants (Count of Participants) |
---|
| total enrolled participants | week 12 | week 24 | week 36 | week 48 |
---|
Truvada | 148 | 107 | 74 | 31 | 22 |
[back to top]
Percentage of Study Participants Who Seroconverted During the Study, Measured Until Month 52
Frequency of HIV infection as measured by seroconversion of study participants during the approximate 12 months of follow up. HIV rapid testing was done in parallel using Determine™ HIV-1/2 Ag/Ab Combo and Uni-Gold™ Recombigen® HIV-1/2. If the rapid HIV test was reactive, an HIV-1 RNA qualitative assay (Abbot) was performed. A positive test was confirmed with a second blood sample collected a week later. (NCT02213328)
Timeframe: Measured through Week 52
Intervention | Participants (Count of Participants) |
---|
Truvada | 1 |
[back to top]
Number of Adolescents Enrolled and Retained in the Study
Count of participants who had been enrolled in the study and successfully completed the study (NCT02213328)
Timeframe: Measured through Week 52
Intervention | Participants (Count of Participants) |
---|
| Number of participants enrolled | Number of participants completing the study |
---|
Truvada | 148 | 120 |
[back to top]
Reported Consistent Condom Use as Evidenced by Participant Responses to Interviewer-administered Questionnaires Adminstered at the Enrolment Visit
Reported consistent condom use as evidenced by participant responses to interviewer-administered questionnaires (NCT02213328)
Timeframe: Baseline
Intervention | Participants (Count of Participants) |
---|
Truvada | 100 |
[back to top]
Number of Participants With Acceptability as Per Questionnaire Administered at Week 48
Acceptability was assessed by asking partcipants if they liked truvada, at the week 48 visit (NCT02213328)
Timeframe: Measured at Week 48
Intervention | Participants (Count of Participants) |
---|
Truvada | 97 |
[back to top]
Number of Participants Who Used PrEP at Any Time Point During the Study, Measured With Drug Levels at M4/8/12/24/36
Number of participants who used oral PrEP at any time during the study and had drug levels present at any time point (NCT02213328)
Timeframe: Measured through Week 48
Intervention | Participants (Count of Participants) |
---|
Truvada | 141 |
[back to top]
Number of Participants Reporting Multiple Partners in the Preceding Year as Evidenced by Participant Responses to Interviewer Administered Questionnaires at Enrolment
Participants reporting multiple partners during interviewer administered questionnaires (NCT02213328)
Timeframe: Baseline
Intervention | Participants (Count of Participants) |
---|
Truvada | 49 |
[back to top]
The Percentage of Participants Who Report Willingness to Use the Study Regimen, Take up PrEP, and Remain on PrEP as Part of a Comprehensive Prevention Package
The percentage of participants who report willingness to use the study regimen, take up PrEP, and remain on PrEP as part of a comprehensive prevention package measured at different time points in the study (NCT02213328)
Timeframe: Measured through Week 48
Intervention | Participants (Count of Participants) |
---|
| Percentage of partcipants who reported willingness to use the study regimen | Percentage of participants who took up PrEP | Percentage of participants who remained on PrEP at 12 weeks | Percentage of participants who remained on PrEP at 24 weeks | Percentage of participants who remained on PrEP at 36 weeks | Percentage of participants who remained on PrEP at week 48 |
---|
Truvada | 148 | 148 | 122 | 87 | 85 | 85 |
[back to top]
Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline
(NCT02251236)
Timeframe: Baseline
Intervention | ng/mL (Median) |
---|
Stribild Arm | 4.3 |
Genvoya Arm | 2.72 |
[back to top]
Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24
(NCT02251236)
Timeframe: Week 24
Intervention | ng/mL (Median) |
---|
Stribild Arm | 5.90 |
Genvoya Arm | 3.09 |
[back to top]
Concentration of Tenofovir in Cerebrospinal Fluid at Baseline
(NCT02251236)
Timeframe: Baseline
Intervention | ng/mL (Median) |
---|
Stribild Arm | 3.03 |
Genvoya Arm | 0.49 |
[back to top]
Concentration of Tenofovir in Cerebrospinal Fluid at Week 24
(NCT02251236)
Timeframe: Week 24
Intervention | ng/mL (Median) |
---|
Stribild Arm | 0.507 |
Genvoya Arm | 0.481 |
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
[back to top]
Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 96
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Week 96
Intervention | percentage of participants (Number) |
---|
| Grade 3 AEs | Grade 4 AEs | SAEs | Premature discontinuations due to AEs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 11.6 | 0.8 | 10.8 | 2.8 |
,Switch to D/C/F/TAF | 3.7 | 1.4 | 2.7 | 0.3 |
[back to top]
Percentage of Participants With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations Due to Adverse Events Post-Week 96 to End of Extension
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Grade 3 AEs | Grade 4 AEs | SAEs | Premature discontinuations due to AEs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 3.5 | 0 | 3.2 | 1.0 |
,Switch to D/C/F/TAF | 5.2 | 1.3 | 4.8 | 1.3 |
[back to top]
Percentage of Participants With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to End of Extension
Percentage of participants with HIV RNA <50, <20, and <200 copies/mL post Week 96 to end of extension were reported. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Week 96 + 6 months (<50 copies/mL) | Week 96 + 12 months (<50 copies/mL) | Week 96 + 18 months (<50 copies/mL) | Week 96 + 24 months (<50 copies/mL) | Week 96 + 30 months (<50 copies/mL) | Week 96 + 36 months (<50 copies/mL) | Week 96 + 6 months (<20 copies/mL) | Week 96 + 12 months (<20 copies/mL) | Week 96 + 18 months (<20 copies/mL) | Week 96 + 24 months (<20 copies/mL) | Week 96 + 30 months (<20 copies/mL) | Week 96 + 36 months (<20 copies/mL) | Week 96 + 6 months (<200 copies/mL) | Week 96 + 12 months (<200 copies/mL) | Week 96 + 18 months (<200 copies/mL) | Week 96 + 24 months (<200 copies/mL) | Week 96 + 30 months (<200 copies/mL) | Week 96 + 36 months (<200 copies/mL) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 97.7 | 99.0 | 98.1 | 97.5 | 94.7 | 100.0 | 85.8 | 89.7 | 92.4 | 90.1 | 89.5 | 94.7 | 99.7 | 100.0 | 98.7 | 97.5 | 96.5 | 100.0 |
,Switch to D/C/F/TAF | 96.3 | 96.7 | 98.2 | 95.7 | 91.4 | 68.8 | 88.2 | 91.6 | 92.8 | 87.0 | 84.5 | 62.5 | 99.3 | 99.5 | 98.2 | 97.8 | 98.3 | 87.5 |
[back to top]
Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96
Intervention | percentage of participants (Number) |
---|
| At Week 48: < 20 Copies per mL | At Week 48: <50 Copies per mL | At Week 48: <200 Copies per mL |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 79.9 | 88.7 | 91.7 |
[back to top]
Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96
Intervention | percentage of participants (Number) |
---|
| At Week 96: <20 Copies per mL | At Week 96: <50 Copies per mL | At Week 96: <200 Copies per mL |
---|
Switch to D/C/F/TAF | 78.4 | 93.8 | 96.9 |
[back to top]
Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
Percentage of participants with HIV-1 RNA less than (<) 20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation. (NCT02431247)
Timeframe: At Week 48 and 96
Intervention | percentage of participants (Number) |
---|
| At Week 48: < 20 Copies per mL | At Week 48: <50 Copies per mL | At Week 48: <200 Copies per mL | At Week 96: <20 Copies per mL | At Week 96: <50 Copies per mL | At Week 96: <200 Copies per mL |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 82.6 | 91.2 | 93.1 | 73.2 | 85.1 | 86.7 |
[back to top]
Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| At week 48: <20 Copies per mL | At week 48: <200 Copies per mL |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 79.3 | 90.6 |
[back to top]
Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| At week 96: <20 Copies per mL | At week 96: <200 Copies per mL |
---|
Switch to D/C/F/TAF | 83.5 | 96.9 |
[back to top]
Percentage of Participants With HIV-1 RNA <20 and 200 Copies Per mL at Weeks 48 and 96 Defined by FDA Snapshot Approach
Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Weeks 48 and 96
Intervention | percentage of participants (Number) |
---|
| At week 48: <20 Copies per mL | At week 48: <200 Copies per mL | At week 96: <20 Copies per mL | At week 96: <200 Copies per mL |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 82.6 | 92.8 | 76.2 | 86.2 |
[back to top]
Percentage of Participants With Non-PDVF by Kaplan-Meier Estimates
Percentage of participants with non-PDVF by Kaplan-Meier Estimates were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 2 years and 6 months)
Intervention | percentage of participants (Number) |
---|
| Week 96 | Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 100 | 99.6 | 99.6 | 98.6 | 97.3 | 97.3 |
,Switch to D/C/F/TAF | 100 | 99.2 | 99.2 | 97.8 | 97.8 | 92.5 |
[back to top]
Percentage of Participants With PDVF Post-week 96 to End of Extension
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF | Virologic non-response | Virologic rebound | Viremic at final time point |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 1.0 | 0 | 1.0 | 0 |
,Switch to D/C/F/TAF | 2.1 | 0 | 1.4 | 0.7 |
[back to top]
Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF (Baseline - Switch) | Virologic non-response (Baseline - Switch) | Virologic rebound (Baseline - Switch) | Viremic at final time point (Baseline - Switch) |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 4.4 | 0 | 3.9 | 0.6 |
[back to top]
Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF (Baseline - Week 96) | Virologic non-response (Baseline - Week 96) | Virologic rebound (Baseline-Week 96) | Viremic at final time point (Baseline-Week 96) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 4.1 | 0.6 | 0.3 | 0.6 |
[back to top]
Percentage of Participants With Protocol-defined Virologic Failure (PDVF)
Percentage of participants with PDVF were reported. Protocol-defined virologic failure was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). (NCT02431247)
Timeframe: From Baseline up to Week 96
Intervention | percentage of participants (Number) |
---|
| Participants who met PDVF (Switch - Week 96) | Virologic non-response (Switch - Week 96) | Virologic rebound (Switch - Week 96) | Viremic at final time point (Switch - Week 96) |
---|
Switch to D/C/F/TAF | 1.1 | 0 | 1.1 | 0 |
[back to top]
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates
Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Week 96 | Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months |
---|
Switch to D/C/F/TAF | 100 | 97.4 | 94.1 | 89.5 | 86.4 | 79.1 |
[back to top]
Percentage of Participants With Time to Treatment Failure by Kaplan-Meier Estimates
Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). (NCT02431247)
Timeframe: From Week 96 to end of extension (up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Week 96 | Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months | Week 96 + 36 months |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 100 | 98.9 | 95.6 | 90.6 | 87.1 | 84.8 | 84.8 |
[back to top]
Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)
"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by dual energy x-ray absorptiometry (DEXA) scan. Positive values are best values and negative values are worst values of change. Percent change from baseline in hip and spine BMD was assessed." (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | Percent change (Least Squares Mean) |
---|
| Hip region BMD (Week 24) | Spine region BMD (Week 24) | Hip region BMD (Week 48) | Spine region BMD (Week 48) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.29 | -1.34 | 0.17 | -0.68 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -1.66 | -3.43 | -2.69 | -2.38 |
[back to top]
Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide
The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)
Intervention | h*ng/mL (Mean) |
---|
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)] | 132.3117 |
[back to top]
Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post-dose. (NCT02431247)
Timeframe: 0 to 24 hours post dose
Intervention | hours*nanogram per milliliter (h*ng/mL) (Mean) |
---|
Darunavir 800 mg [D/C/F/TAF] | 87909.3282 |
[back to top]
Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Week 48 were assessed. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | Cells per millimeter cube (cells/mm^3) (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 190.49 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 172.01 |
[back to top]
[back to top]
[back to top]
[back to top]
Change From Baseline in log10 HIV-1 RNA Levels at Week 48
Change from baseline in log10 HIV-1 RNA levels were reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | log10 HIV-1 RNA copies per mL (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -2.95 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -2.91 |
[back to top]
Change From Baseline in Serum Creatinine at Week 48
Change from baseline in serum creatinine at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | milligram per deciliter (mg/dL) (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.05 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0.09 |
[back to top]
Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48
Change from baseline in UACR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | mg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.58 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -0.15 |
[back to top]
Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48
Change from baseline in UB2MGCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | mcg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -30.42 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 18.36 |
[back to top]
Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48
Change from baseline in UPCR at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | milligram per gram (mg/g) (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -15.72 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -10.53 |
[back to top]
Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48
Change from baseline in URBPCR at Week 48 were reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | microgram per gram (mcg/g) (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 7.00 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 35.02 |
[back to top]
Change From Reference in ALP Levels
Change from reference in ALP levels at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | U/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.9 |
Switch to D/C/F/TAF | -9.7 |
[back to top]
Change From Reference in CD4+ Cell Count at Week 96
The immunologic change was determined by changes in cluster of differentiation (CD4+) cell count. Change from reference in CD4+ cell count at Week 96 was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | cells/mm^3 (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 228.85 |
Switch to D/C/F/TAF | 27.01 |
[back to top]
[back to top]
[back to top]
[back to top]
Change From Reference in Levels of 25-OH Vitamin D
Change from reference in 25-OH Vitamin D were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | nmol/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 21.3 |
Switch to D/C/F/TAF | -10.3 |
[back to top]
Change From Reference in Levels of PTH
Change from reference in PTH levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | pmol/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.290 |
Switch to D/C/F/TAF | -1.283 |
[back to top]
Change From Reference in Levels of Serum CTX
Change from reference in serum CTX levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.041 |
Switch to D/C/F/TAF | -0.162 |
[back to top]
Change From Reference in Levels of Serum P1NP
Change from reference in serum P1NP levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/L (Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 2.817 |
Switch to D/C/F/TAF | -11.963 |
[back to top]
Change From Reference in log10 HIV-1 RNA Levels at Week 96
Change from reference in log10 HIV-1 RNA levels were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for Test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | log10 HIV-1 RNA copies per mL (Least Squares Mean) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -2.72 |
Switch to D/C/F/TAF | -0.0027 |
[back to top]
Change From Reference in Serum Creatinine
Change from reference in serum creatinine was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mg/dL (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.045 |
Switch to D/C/F/TAF | -0.034 |
[back to top]
Change From Reference in UACR
Change from reference in UACR at Week 96 was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.70 |
Switch to D/C/F/TAF | -0.49 |
[back to top]
Change From Reference in UB2MGCR
Change from reference in UB2MGCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -27.04 |
Switch to D/C/F/TAF | -40.53 |
[back to top]
Change From Reference in UPCR
Change from reference in UPCR was reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF+ FTC/TDF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -15.46 |
Switch to D/C/F/TAF | -1.40 |
[back to top]
Change From Reference in URBPCR
Change from reference in URBPCR at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | mcg/g (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 13.70 |
Switch to D/C/F/TAF | -35.53 |
[back to top]
Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48
Percent change from baseline in FEPO4 at Week 48 was reported. (NCT02431247)
Timeframe: Baseline and Week 48
Intervention | Percent change (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 16.00 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 22.55 |
[back to top]
Percent Change From Reference in Urine FEPO4
Percent change from reference in FEPO4 at Week 96 were reported. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | Percent change in urine FEPO4 (Median) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 18.52 |
Switch to D/C/F/TAF | -7.51 |
[back to top]
Percentage of Participants With HIV-1 RNA <50 Copies Per mL at Week 96 Defined by FDA Snapshot Approach
Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 96), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 96), 3) no viral load data in the Week 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 96
Intervention | percentage of participants (Number) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 85.1 |
Switch to D/C/F/TAF | 94.2 |
[back to top]
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. (NCT02431247)
Timeframe: At Week 48
Intervention | percentage of participants (Number) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 91.4 |
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 88.4 |
[back to top]
Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide
C0-2h is defined as the plasma concentrations 2 hours after dosing. (NCT02431247)
Timeframe: 0 to 2 hours post dose
Intervention | ng/mL (Mean) |
---|
Tenofovir Alafenamide 10 mg [D/C/F/TAF (Test)] | 11.9785 |
[back to top]
Predose (Trough) Plasma Concentration (C0h) of Darunavir
C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration. (NCT02431247)
Timeframe: 30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)
Intervention | nanogram per milliliter (ng/mL) (Mean) |
---|
Darunavir 800 mg [D/C/F/TAF (Test)] | 1898.9100 |
[back to top]
CD4+ Cell Count Post-Week From 96 to End of Extension
The immunologic change was determined by Cluster of CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed. (NCT02431247)
Timeframe: Week 96 to end of extension (up to 3 years)
Intervention | cells/mm^3 (Mean) |
---|
| Week 96 + 6 months | Week 96 + 12 months | Week 96 + 18 months | Week 96 + 24 months | Week 96 + 30 months | Week 96 + 36 months |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 790.2 | 779.4 | 789.8 | 781.9 | 741.6 | 784.7 |
,Switch to D/C/F/TAF | 749.7 | 774.3 | 758.4 | 784.1 | 736.7 | 778.4 |
[back to top]
Change From Baseline in Alkaline Phosphatase (ALP) Levels at Weeks 24 and 48
Change from baseline in ALP at Weeks 24 and 48 was reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | Units per liter (U/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -3.2 | -1.1 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 12.0 | 15.1 |
[back to top]
Change From Baseline in BMD T-score of Hip and Spine
BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | BMD T-score (Mean) |
---|
| Hip region BMD T-score (Week 24) | Spine region BMD T-score (Week 24) | Hip region BMD T-score (Week 48) | Spine region BMD T-score (Week 48) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.019 | -0.121 | 0.015 | -0.061 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | -0.109 | -0.322 | -0.177 | -0.225 |
[back to top]
Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48
Change from baseline in 25-OH Vitamin D levels at Week 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | nanomol per liter (nmol/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 12.7 | 16.9 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 22.1 | 28.3 |
[back to top]
Change From Baseline in Levels of Parathyroid Hormone (PTH) at Weeks 24 and 48
Change from baseline in PTH at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | Picomol per liter (pmol/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.113 | -0.004 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0.777 | 0.633 |
[back to top]
Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Weeks 24 and 48
Change from baseline in serum CTX at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | mcg/L (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0.047 | 0.046 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0.283 | 0.226 |
[back to top]
Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Weeks 24 and 48
Change from baseline in serum P1NP at Weeks 24 and 48 were reported. (NCT02431247)
Timeframe: Baseline, Weeks 24 and 48
Intervention | microgram per liter (mcg/L) (Mean) |
---|
| Week 24 | Week 48 |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 1.892 | 0.065 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 24.679 | 24.251 |
[back to top]
Change From Reference in BMD T-score of Hip and Spine at Week 96
BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group. (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | BMD T-score (Mean) |
---|
| Hip region BMD T-score | Spine region BMD T-score |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.016 | -0.090 |
,Switch to D/C/F/TAF | 0.025 | 0.034 |
[back to top]
Number of Participants With ARV Resistance
Number of participants with DRV, FTC, TDF/TAF resistance were reported. (NCT02431247)
Timeframe: Baseline to end of extension (up to 4 years)
Intervention | Participants (Count of Participants) |
---|
| DRV resistance-associated mutations (RAMs) | TFV RAMs | FTC RAMs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 0 | 0 | 2 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 0 | 0 | 1 |
,Switch to D/C/F/TAF | 0 | 0 | 2 |
[back to top]
Percent Change From Reference in Hip and Spine BMD
"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DEXA scan. Positive values are best values and negative values are worst values of change. Percent change from reference in hip and spine BMD was assessed. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group." (NCT02431247)
Timeframe: From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
Intervention | Percent change in BMD (Mean) |
---|
| Hip region BMD | Spine region BMD |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | -0.2565 | -0.9349 |
,Switch to D/C/F/TAF | 0.5467 | 0.4829 |
[back to top]
Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Baseline to Switch (double-blind treatment) |
---|
DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 82.6 |
[back to top]
Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Switch to End of Extension (open-label D/C/F/TAF) |
---|
Switch to D/C/F/TAF | 88.7 |
[back to top]
Percentage of Participants With >95% Treatment Adherence Assessed by Drug Accountability
Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in participants who returned all dispensed bottles prior to or at the last visit in the study. Adherent participants were defined as having an adherence >95% as assessed by drug accountability. (NCT02431247)
Timeframe: Baseline to Switch and switch to EOE to Open-Label D/C/F/TAF (Up to 3 years)
Intervention | percentage of participants (Number) |
---|
| Baseline to Switch (double-blind treatment) | Switch to End of Extension (open-label D/C/F/TAF) |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 87.2 | 92.2 |
[back to top]
Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events Through Week 48
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. (NCT02431247)
Timeframe: Up to Weeks 48
Intervention | percentage of participants (Number) |
---|
| Grade 3 AEs | Grade 4 AEs | SAEs | Premature discontinuations due to AEs |
---|
D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) | 4.7 | 0.6 | 4.7 | 1.9 |
,DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) | 4.4 | 1.7 | 5.8 | 4.4 |
[back to top]
Number of Participants With PrEP Adherence
Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL. (NCT02495779)
Timeframe: Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)
Intervention | Participants (Count of Participants) |
---|
Intervention | 45 |
[back to top]
HIV RNA Change From Baseline to Day 10
An HIV RNA decline of >=0.5 log by day 10 will be considered to be an adequate virologic response, to proceed to the second phase of the study. (NCT02556333)
Timeframe: 10 days
Intervention | log HIV RNA copies/mL (Number) |
---|
TAF Treatment | 0.01 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
B/F/TAF | 93.6 |
ABC/DTG/3TC | 95.0 |
[back to top]
Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT02603120)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|
B/F/TAF | 1.1 |
ABC/DTG/3TC | 0.4 |
[back to top]
Spine Bone Mineral Density (BMD) at Baseline
(NCT02603120)
Timeframe: Baseline
Intervention | g/cm^2 (Mean) |
---|
B/F/TAF | 1.124 |
ABC/DTG/3TC | 1.103 |
[back to top]
Change From Baseline in CD4+ Cell Count at Week 48
(NCT02603120)
Timeframe: Baseline; Week 48
Intervention | cells/µL (Mean) |
---|
B/F/TAF | -31 |
ABC/DTG/3TC | 4 |
[back to top]
Hip Bone Mineral Density at Baseline
(NCT02603120)
Timeframe: Baseline
Intervention | g/cm^2 (Mean) |
---|
B/F/TAF | 1.006 |
ABC/DTG/3TC | 0.996 |
[back to top]
Percentage Change From Baseline in Hip BMD at Week 48
(NCT02603120)
Timeframe: Baseline; Week 48
Intervention | percentage change (Mean) |
---|
B/F/TAF | 0.156 |
ABC/DTG/3TC | 0.299 |
[back to top]
Percentage Change From Baseline in Spine BMD at Week 48
(NCT02603120)
Timeframe: Baseline; Week 48
Intervention | percentage change (Mean) |
---|
B/F/TAF | 0.692 |
ABC/DTG/3TC | 0.416 |
[back to top]
Percent Change in Bone Mineral Density From Baseline at the Lumbar Spine
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic. (NCT02815566)
Timeframe: Baseline, 48 weeks and 96 weeks
Intervention | Percent Change (Median) |
---|
| 48 weeks | 96 weeks |
---|
Delayed Switch | -2.32 | 0.7 |
,Immediate Switch | 1.97 | 2.33 |
[back to top]
% Change in Bone Mineral Density From Baseline at the Femoral Neck
The outcome measures presented are descriptive as enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There are limited results at the week 48 timepoint due to the COVID pandemic. (NCT02815566)
Timeframe: Baseline, 48 weeks and 96 weeks
Intervention | Percent Change (Median) |
---|
| 48 weeks | 96 weeks |
---|
Delayed Switch | 0.22 | 0.70 |
,Immediate Switch | 1.46 | 2.33 |
[back to top]
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 96 | HDL Cholesterol, Direct, Week 96 | LDL Cholesterol, Week 96, | Triglycerides, Week 96, |
---|
DTG + 3TC-Double Blind Phase | 0.379 | 0.199 | 0.147 | 0.129 |
,DTG + TDF/FTC-Double Blind Phase | -0.104 | 0.090 | -0.154 | -0.112 |
[back to top]
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 12.89 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 15.87 |
[back to top]
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
Blood samples were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C . Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Milligrams per Liter (mg/L) (Mean) |
---|
DTG + 3TC-Double Blind Phase | -0.11 |
DTG + TDF/FTC-Double Blind Phase | -0.09 |
[back to top]
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Milligrams per Liter (mg/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.12 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.11 |
[back to top]
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Ratio (Mean) |
---|
DTG + 3TC-Double Blind Phase | -0.213 |
DTG + TDF/FTC-Double Blind Phase | -0.402 |
[back to top]
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Ratio (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.229 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.386 |
[back to top]
Change From Baseline in EQ-5D-5L Utility Score at Week 96
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC-Double Blind Phase | 0.0079 |
DTG + TDF/FTC-Double Blind Phase | 0.0091 |
[back to top]
Change From Baseline in EQ-5D-5L Utility Score at Week 144
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.0143 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0.0135 |
[back to top]
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC-Double Blind Phase | 4.1 |
DTG + TDF/FTC-Double Blind Phase | 2.4 |
[back to top]
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 5.2 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 3.0 |
[back to top]
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC-Double Blind Phase | -2.2 |
DTG + TDF/FTC-Double Blind Phase | 0.7 |
[back to top]
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -2.0 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 2.9 |
[back to top]
CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 96
Intervention | Cells per cubic millimeter (cells/mm^3) (Mean) |
---|
DTG + 3TC Double Blind Phase | 732.8 |
DTG + TDF/FTC-Double Blind Phase | 711.5 |
[back to top]
CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831673)
Timeframe: Week 144
Intervention | Cells per cubic millimeter (cells/mm^3) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 767.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 758.2 |
[back to top]
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 5 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4 |
[back to top]
Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 18 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 17 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Cells per cubic millimeter (Mean) |
---|
DTG + 3TC - Double-blind Phase | 264.7 |
DTG + TDF/FTC-Double Blind Phase | 253.8 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Cells per cubic millimeter (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 301.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 303.2 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelets. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grades 1 to 4 | Hemoglobin, Grades 2 to 4 | Hemoglobin, Grades 3 to 4 | Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grades 1 to 4 | Leukocytes, Grades 2 to 4 | Leukocytes, Grades 3 to 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grades 1 to 4 | Neutrophils, Grades 2 to 4 | Neutrophils, Grades 3 to 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grades 1 to 4 | Platelets, Grades 2 to 4 | Platelets, Grades 3 to 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 9 | 1 | 0 | 8 | 1 | 0 | 0 | 16 | 4 | 0 | 12 | 4 | 0 | 0 | 25 | 19 | 7 | 6 | 12 | 5 | 2 | 14 | 8 | 1 | 6 | 7 | 0 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 7 | 1 | 0 | 6 | 1 | 0 | 0 | 3 | 2 | 0 | 1 | 2 | 0 | 0 | 18 | 11 | 6 | 7 | 5 | 5 | 1 | 11 | 4 | 1 | 7 | 3 | 1 | 0 |
[back to top]
Change From Baseline in Renal Biomarker-Serum RBP at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC-Double Blind Phase | 1.535 |
DTG + TDF/FTC-Double Blind Phase | 7.704 |
[back to top]
Change From Baseline in Renal Biomarker-Serum RBP at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 1.760 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 8.855 |
[back to top]
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC-Double Blind Phase | 12.75 |
DTG + TDF/FTC-Double Blind Phase | 16.10 |
[back to top]
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Ratio (Geometric Mean) |
---|
| Serum B2M, Week 24, n=338, 335 | Serum B2M, Week 48, n=324, 332 | Urine B2M, Week 24, n=121, 95 | Urine B2M, Week 48, n=119, 103 | Urine Albumin/Creatinine, Week 24, n=254, 252 | Urine Albumin/Creatinine , Week 48, n=237, 244 | Urine B2M/Urine Creatinine, Week 24, n=121, 95 | Urine B2M/Urine Creatinine, Week 48, n=114, 100 | Urine Phosphate, Week 24, n=330, 332 | Urine Phosphate, Week 48, n=316, 330 | Urine Protein/Creatinine, Week 24, n=269, 265 | Urine Protein/Creatinine, Week 48, n=252, 269 | Urine RBP 4, Week 24, n=332, 330 | Urine RBP 4, Week 48, n=318, 328 | Urine RBP 4/Urine Creatinine, Week 24, n=329, 330 | Urine RBP 4/Urine Creatinine, Week 48, n=304, 318 |
---|
DTG + 3TC-Double Blind Phase | 0.798 | 0.806 | 0.887 | 0.900 | 1.014 | 0.934 | 0.852 | 0.888 | 1.115 | 1.061 | 0.850 | 0.879 | 0.934 | 1.115 | 0.919 | 1.147 |
,DTG + TDF/FTC-Double Blind Phase | 0.872 | 0.892 | 1.351 | 1.338 | 1.050 | 1.048 | 1.331 | 1.278 | 1.012 | 1.075 | 1.016 | 1.061 | 1.073 | 1.490 | 1.110 | 1.500 |
[back to top]
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine, Week 96, n=222, 243 | Urine B2M/Urine Creatinine , Week 96, n=107, 104 | Urine Phosphate, Week 96, n=292, 316 | Urine Protein/Creatinine, Week 96, n=238, 258 | Urine RBP 4/Urine Creatinine, Week 96, n=289, 311 |
---|
DTG + 3TC-Double Blind Phase | 0.924 | 0.794 | 1.113 | 0.868 | 1.310 |
,DTG + TDF/FTC-Double Blind Phase | 1.101 | 1.441 | 1.066 | 1.053 | 1.771 |
[back to top]
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine , Week 144, n=207, 212 | Urine B2M/Urine Creatinine , Week 144, n=100, 102 | Urine Phosphate, Week 144, n=274, 294 | Urine Protein/Creatinine , Week 144, n=225,232 | Urine RBP 4/Urine Creatinine, Week 144, n=276, 292 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 1.050 | 0.751 | 1.040 | 0.988 | 1.648 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.146 | 1.518 | 0.955 | 1.210 | 2.425 |
[back to top]
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents are not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Weeks 24 and Week 48
Intervention | Percentage of participants (Number) |
---|
| Week 24, n=309, 316 | Week 48, n=318, 320 |
---|
DTG + 3TC-Double Blind Phase | 4 | 4 |
,DTG + TDF/FTC-Double Blind Phase | 2 | 3 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31,29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297, 306 | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29, 46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39, 36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
---|
DTG + 3TC-Double Blind Phase | 90 | 93 | 93 | 92 | 93 | 91 | 93 | 93 | 92 | 93 | 92 | 89 | 94 |
,DTG + TDF/FTC-Double Blind Phase | 86 | 94 | 96 | 92 | 95 | 93 | 85 | 95 | 87 | 95 | 81 | 93 | 94 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31, 29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297,306, | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29,46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39,36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
---|
DTG + 3TC-Double Blind Phase | 65 | 86 | 83 | 85 | 84 | 84 | 86 | 85 | 81 | 86 | 79 | 78 | 86 |
,DTG + TDF/FTC-Double Blind Phase | 90 | 89 | 88 | 90 | 90 | 89 | 87 | 90 | 88 | 90 | 81 | 90 | 91 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31,29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297, 306 | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29, 46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39, 36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
---|
DTG + 3TC-Double Blind Phase | 81 | 91 | 88 | 90 | 92 | 86 | 90 | 90 | 88 | 90 | 87 | 92 | 89 |
,DTG + TDF/FTC-Double Blind Phase | 90 | 93 | 94 | 92 | 93 | 94 | 87 | 93 | 91 | 94 | 81 | 98 | 94 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=31, 29 | Baseline CD4+ cell count, >200,n=325,329 | Female, n=59, 52 | Male, n=297,306, | Age, <35,n= 211, 205 | Age, 35 to <50,n=116, 107 | Age, >=50, n=29,46 | Baseline plasma HIV-1 RNA, <=100000,n=282,282 | Baseline plasma HIV-1 RNA, >100000,n=74, 76 | Race, White, n=244,247 | Race, African American/African H., n=39,36 | Race, Asian, n=37, 42 | Race, Other, n=36, 33 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 58 | 81 | 71 | 80 | 77 | 81 | 83 | 79 | 78 | 82 | 69 | 73 | 78 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 83 | 83 | 85 | 82 | 83 | 83 | 78 | 82 | 87 | 85 | 72 | 81 | 79 |
[back to top]
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Serum or Plasma Cholesterol, Week 24, n=294, 297 | Serum or Plasma Cholesterol, Week 48, n=280, 289 | HDL Cholesterol, Direct, Week 24, n=294, 297 | HDL Cholesterol, Direct, Week 48, n=280, 289 | LDL Cholesterol, Week 24, n=294, 297 | LDL Cholesterol, Week 48, n=280, 289 | Triglycerides ,Week 24, n=294, 297 | Triglycerides , Week 48, n=280, 289 |
---|
DTG + 3TC-Double Blind Phase | 9.4 | 10.5 | 16.4 | 15.0 | 12.4 | 14.8 | 8.5 | 12.8 |
,DTG + TDF/FTC-Double Blind Phase | -4.7 | -2.4 | 3.4 | 5.0 | -8.1 | -4.0 | 4.3 | 4.4 |
[back to top]
Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Total/HDL Cholesterol Ratio, Week 24, n=294, 297 | Total/HDL Cholesterol Ratio, Week 48, n=280, 289 |
---|
DTG + 3TC-Double Blind Phase | -4.0 | -0.2 |
,DTG + TDF/FTC-Double Blind Phase | -4.6 | -4.4 |
[back to top]
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI, DTG, Sensitive, n=,5,4 | INSTI, DTG, Resistant, n=5,4 | INSTI, EGV, Sensitive, n=5,4 | INSTI, EGV, Resistant, n=5,4 | INSTI, RAL, Sensitive, n=5,4 | INSTI, RAL, Resistant, n=5,4 | NRTI, 3TC, Sensitive, n=5,5 | NRTI, 3TC, Resistant, n=5,5 | NRTI, ABC, Sensitive, n=5,5 | NRTI, ABC, Resistant, n=5,5 | NRTI, AZT, Sensitive, n=5,5 | NRTI, AZT, Resistant, n=5,5 | NRTI, D4T, Sensitive, n=5,5 | NRTI, D4T, Resistant, n=5,5 | NRTI, DDI, Sensitive, n=5,5 | NRTI, DDI, Resistant, n=5,5 | NRTI, FTC, Sensitive, n=5,5 | NRTI, FTC, Resistant, n=5,5 | NRTI, TDF, Sensitive, n=5,5 | NRTI, TDF, Resistant, n=5,5 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4 | 0 | 4 | 0 | 4 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 | 5 | 0 |
[back to top]
Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI Mutations | Major mutations of NRTI |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0 | 0 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| ALT, Grades 1 to 4 | ALT, Grades 2 to 4 | ALT, Grades 3 to 4 | ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 3 | ALT, Grade 4 | Albumin, Grades 1 to 4 | Albumin, Grades 2 to 4 | Albumin, Grades 3 to 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | ALP, Grades 1 to 4 | ALP, Grades 2 to 4 | ALP, Grades 3 to 4 | ALP, Grade 1 | ALP, Grade 2 | ALP, Grade 3 | ALP, Grade 4 | AST, Grades 1 to 4 | AST, Grades 2 to 4 | AST, Grades 3 to 4 | AST, Grade 1 | AST, Grade 2 | AST, Grade 3 | AST, Grade 4 | Bilirubin, Grades 1 to 4 | Bilirubin, Grades 2 to 4 | Bilirubin, Grades 3 to 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | CO2, Grades 1 to 4 | CO2, Grades 2 to 4 | CO2, Grades 3 to 4 | CO2, Grade 1 | CO2, Grade 2 | CO2, Grade 3 | CO2, Grade 4 | Cholesterol, Grades 1 to 4 | Cholesterol, Grades 2 to 4 | Cholesterol, Grades 3 to 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | CK, Grades 1 to 4 | CK, Grades 2 to 4 | CK, Grades 3 to 4 | CK, Grade 1 | CK, Grade 2 | CK, Grade 3 | CK, Grade 4 | Creatinine, Grades 1 to 4 | Creatinine, Grades 2 to 4 | Creatinine, Grades 3 to 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Direct Bilirubin, Grades 1 to 4 | Direct Bilirubin, Grades 2 to 4 | Direct Bilirubin, Grades 3 to 4 | Direct Bilirubin, Grade 1 | Direct Bilirubin, Grade 2 | Direct Bilirubin, Grade 3 | Direct Bilirubin, Grade 4 | GFR from creatinine adjusted for BSA Grades 1 to 4 | GFR from creatinine adjusted for BSA Grades 2 to 4 | GFR from creatinine adjusted for BSA Grades 3 to 4 | GFR from creatinine adjusted for BSA, Grade 1 | GFR from creatinine adjusted for BSA, Grade 2 | GFR from creatinine adjusted for BSA Grades 3 | GFR from creatinine adjusted for BSA, Grade 4 | Hypercalcaemia, Grades 1 to 4 | Hypercalcaemia, Grades 2 to 4 | Hypercalcaemia, Grades 3 to 4 | Hypercalcaemia, Grade 1 | Hypercalcaemia, Grade 2 | Hypercalcaemia, Grade 3 | Hypercalcaemia, Grade 4 | Hyperglycemia, Grades 1 to 4 | Hyperglycemia, Grades 2 to 4 | Hyperglycemia, Grades 3 to 4 | Hyperglycemia, Grade 1 | Hyperglycemia, Grade 2 | Hyperglycemia, Grade 3 | Hyperglycemia, Grade 4 | Hyperkalemia, Grades 1 to 4 | Hyperkalemia, Grades 2 to 4 | Hyperkalemia, Grades 3 to 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grades 1 to 4 | Hypernatremia, Grades 2 to 4 | Hypernatremia, Grades 3 to 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypocalcaemia, Grades 1 to 4 | Hypocalcaemia, Grades 2 to 4 | Hypocalcaemia, Grades 3 to 4 | Hypocalcaemia, Grade 1 | Hypocalcaemia, Grade 2 | Hypocalcaemia, Grade 3 | Hypocalcaemia, Grade 4 | Hypoglycemia, Grades 1 to 4 | Hypoglycemia, Grades 2 to 4 | Hypoglycemia, Grades 3 to 4 | Hypoglycemia, Grade 1 | Hypoglycemia, Grade 2 | Hypoglycemia, Grade 3 | Hypoglycemia, Grade 4 | Hypokalemia, Grades 1 to 4 | Hypokalemia, Grades 2 to 4 | Hypokalemia, Grades 3 to 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grades 1 to 4 | Hyponatremia, Grades 2 to 4 | Hyponatremia, Grades 3 to 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | LDL Cholesterol, Grades 1 to 4 | LDL Cholesterol, Grades 2 to 4 | LDL Cholesterol, Grades 3 to 4 | LDL Cholesterol, Grade 1 | LDL Cholesterol, Grade 2 | LDL Cholesterol, Grade 3 | LDL Cholesterol, Grade 4 | Lactate Dehydrogenase, Grades 1 to 4 | Lactate Dehydrogenase, Grades 2 to 4 | Lactate Dehydrogenase, Grades 3 to 4 | Lactate Dehydrogenase, Grade 1 | Lactate Dehydrogenase, Grade 2 | Lactate Dehydrogenase, Grade 3 | Lactate Dehydrogenase, Grade 4 | Lipase, Grades 1 to 4 | Lipase, Grades 2 to 4 | Lipase, Grades 3 to 4 | Lipase, Grade 1 | Lipase, Grade 2 | Lipase, Grade 3 | Lipase, Grade 4 | Phosphate, Grades 1 to 4 | Phosphate, Grades 2 to 4 | Phosphate, Grades 3 to 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Triglycerides, Grades 1 to 4 | Triglycerides, Grades 2 to 4 | Triglycerides, Grades 3 to 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 55 | 23 | 14 | 32 | 9 | 7 | 7 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 8 | 3 | 0 | 5 | 3 | 0 | 0 | 52 | 27 | 8 | 25 | 19 | 6 | 2 | 42 | 14 | 4 | 28 | 10 | 2 | 2 | 126 | 8 | 0 | 118 | 8 | 0 | 0 | 77 | 24 | 0 | 53 | 24 | 0 | 0 | 76 | 43 | 26 | 33 | 17 | 15 | 11 | 21 | 1 | 0 | 20 | 1 | 0 | 0 | 14 | 14 | 14 | 0 | 0 | 14 | 0 | 185 | 185 | 13 | 0 | 172 | 13 | 0 | 7 | 0 | 0 | 7 | 0 | 0 | 0 | 91 | 38 | 3 | 53 | 35 | 3 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 0 | 0 | 6 | 0 | 0 | 0 | 14 | 4 | 0 | 10 | 4 | 0 | 0 | 22 | 8 | 2 | 14 | 6 | 1 | 1 | 6 | 0 | 0 | 6 | 0 | 0 | 0 | 25 | 2 | 0 | 23 | 2 | 0 | 0 | 57 | 17 | 5 | 40 | 12 | 5 | 0 | 3 | 0 | 0 | 3 | 0 | 0 | 0 | 65 | 35 | 10 | 30 | 25 | 8 | 2 | 70 | 35 | 2 | 35 | 33 | 2 | 0 | 80 | 12 | 7 | 68 | 5 | 6 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 81 | 25 | 9 | 56 | 16 | 4 | 5 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 10 | 1 | 0 | 9 | 1 | 0 | 0 | 79 | 31 | 13 | 48 | 18 | 9 | 4 | 51 | 17 | 4 | 34 | 13 | 4 | 0 | 116 | 9 | 0 | 107 | 9 | 0 | 0 | 40 | 13 | 1 | 27 | 12 | 1 | 0 | 75 | 52 | 36 | 23 | 16 | 21 | 15 | 31 | 3 | 2 | 28 | 1 | 2 | 0 | 13 | 13 | 13 | 0 | 0 | 13 | 0 | 226 | 226 | 27 | 0 | 199 | 25 | 2 | 4 | 0 | 0 | 4 | 0 | 0 | 0 | 81 | 25 | 2 | 56 | 23 | 2 | 0 | 4 | 1 | 1 | 3 | 0 | 0 | 1 | 3 | 0 | 0 | 3 | 0 | 0 | 0 | 13 | 3 | 1 | 10 | 2 | 1 | 0 | 17 | 3 | 1 | 14 | 2 | 0 | 1 | 7 | 1 | 0 | 6 | 1 | 0 | 0 | 28 | 0 | 0 | 28 | 0 | 0 | 0 | 35 | 14 | 4 | 21 | 10 | 4 | 0 | 5 | 1 | 0 | 4 | 1 | 0 | 0 | 80 | 49 | 18 | 31 | 31 | 10 | 8 | 68 | 47 | 6 | 21 | 41 | 6 | 0 | 62 | 14 | 3 | 48 | 11 | 2 | 1 |
[back to top]
Number of Participants With HIV-1 Disease Progression up to Week 144
HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| No HIV-1 disease progression | From CDC Stage 1 to CDC Stage 3 Event | From CDC Stage 2 to CDC Stage 3 Event | From CDC Stage 3 to New CDC Stage 3 Event | From CDC Stage 1, 2 or 3 to Death |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 352 | 0 | 2 | 1 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 356 | 0 | 2 | 0 | 0 |
[back to top]
[back to top]
Number of Participants With Any AE and SAE up to Week 148
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831673)
Timeframe: Up to Week 148
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 307 | 37 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 316 | 38 |
[back to top]
Number of Participants With AEs by Maximum Severity Grades up to Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| Grade 1 AEs | Grade 2 AEs | Grade 3 AEs | Grade 4 AEs | Grade 5 AEs |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 33 | 229 | 37 | 7 | 1 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 35 | 242 | 34 | 5 | 0 |
[back to top]
Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. . Number of participants who discontinued treatment due to AEs have been reported. (NCT02831673)
Timeframe: Up to Week 24, Week 48 and Week 96
Intervention | Participants (Count of Participants) |
---|
| Up to Week 24 | Up to Week 48 | Up to Week 96 |
---|
DTG + 3TC-Double Blind Phase | 6 | 7 | 14 |
,DTG + TDF/FTC-Double Blind Phase | 4 | 8 | 11 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=240,253 | Baseline plasma HIV-1 RNA,>100000, n=61,67 | Baseline CD4+ cell count,<=200, n=21,26 | Baseline CD4+ cell count,>200, n=280,294 | Age group-1, <35,n= 179,185 | Age group-1, 35 to <50, n=97,95 | Age group-1, >=50, n=25, 40 | Female, n=49,46 | Male, n=252, 274 | Race group, White, n=210,223 | Race group, African Am/African H., n=31,29 | Race group, Asian, n=29,38 | Race group, Other, n=31,30 |
---|
DTG + 3TC-Double Blind Phase | 254.8 | 300.2 | 240.5 | 265.9 | 270.2 | 259.5 | 237.6 | 277.9 | 261.4 | 275.2 | 228.5 | 212.1 | 273.4 |
,DTG + TDF/FTC-Double Blind Phase | 252.9 | 260.1 | 244.4 | 255.1 | 263.0 | 262.0 | 195.9 | 259.1 | 253.5 | 260.0 | 230.2 | 244.8 | 247.3 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=257,264 | Baseline plasma HIV-1 RNA,>100000, n=67,70 | Baseline CD4+ cell count,<=200, n=26, 27 | Baseline CD4+ cell count,>200, n=298, 307 | Age group-1, <35,n= 194, 192 | Age group-1, 35 to <50, n=104, 101 | Age group-1, >=50, n=26, 41 | Female, n=54, 49 | Male, n=270, 285 | Race, White, n=224, 231 | Race, African Am/African H., n=33, 31 | Race, Asian, n=34, 41 | Race, Other, n=33, 31 |
---|
DTG + 3TC-Double Blind Phase | 220.0 | 238.5 | 200.5 | 225.9 | 233.6 | 208.7 | 212.6 | 237.1 | 221.2 | 226.0 | 209.4 | 246.4 | 200.2 |
,DTG + TDF/FTC-Double Blind Phase | 212.4 | 235.5 | 177.9 | 220.7 | 225.2 | 211.2 | 194.8 | 226.8 | 215.6 | 219.7 | 239.9 | 197.2 | 202.7 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age, Gender, and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 24
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=268,268 | Baseline plasma HIV-1 RNA,>100000, n=72,73 | Baseline CD4+ cell count,<=200, n=29,27 | Baseline CD4+ cell count,>200, n=311, 314 | Age, <35,n= 203,199 | Age, 35 to <50, n=109, 100 | Age, >=50, n=28, 42 | Female, n=57,50 | Male, n=283,291 | Race, White, n=236,235 | Race, African Am/African H., n=36,33 | Race, Asian, n=34, 41 | Race, Other, n=34,32 |
---|
DTG + 3TC-Double Blind Phase | 187.72 | 206.63 | 157.01 | 195.11 | 202.76 | 172.05 | 188.79 | 199.45 | 190.21 | 204.78 | 143.84 | 169.80 | 174.30 |
,DTG + TDF/FTC-Double Blind Phase | 167.93 | 205.96 | 120.17 | 180.73 | 177.62 | 179.87 | 159.34 | 181.78 | 175.05 | 182.27 | 170.51 | 165.36 | 149.34 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 24, 48
Intervention | Cells per cubic millimeter (Mean) |
---|
| Week 24, n=340,341 | Week 48, n=324,334 |
---|
DTG + 3TC-Double Blind Phase | 192.2 | 222.2 |
,DTG + TDF/FTC-Double Blind Phase | 175.1 | 217.7 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831673)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Cells per cubic millimeter (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=214,223 | Baseline plasma HIV-1 RNA,>100000, n=56, 64 | Baseline CD4+ cell count,<=200, n=17, 24 | Baseline CD4+ cell count,>200, n=253, 263 | Age group, <35,n=155, 167 | Age group-1, 35 to <50, n=92, 87 | Age group-1, >=50, n=23,33 | Female, n=43, 43 | Male, n=227, 244 | Race group, White, n=190,201 | Race group, African Am/African H., n=26, 26 | Race group, Asian, n=26, 34 | Race group, Other, n=28,26 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 295.7 | 334.3 | 290.2 | 304.7 | 298.0 | 305.6 | 337.4 | 346.6 | 295.9 | 314.2 | 243.8 | 244.0 | 346.2 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 296.1 | 329.6 | 272.9 | 306.2 | 316.0 | 302.1 | 242.2 | 321.7 | 300.0 | 314.0 | 295.1 | 264.1 | 279.9 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Milliliter/minute/1.73*meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 96 | GFR creatinine adjusted, Week 96 |
---|
DTG + 3TC-Double Blind Phase | 11.3 | -15.3 |
,DTG + TDF/FTC-Double Blind Phase | 9.3 | -19.0 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Milliliter/minute/1.73*meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 144, n=283,298 | GFR creatinine adjusted, Week 144, n=271, 289 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 13.0 | -16.7 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 12.1 | -19.3 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted)and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Milliliter/minute/1.73*meter^2 (Mean) |
---|
| GFR-cystatin C adjusted, Week 24, n=338, 336 | GFR-cystatin C adjusted, Week 48, n=324, 332 | GFR-creatinine adjusted, Week 24, n=340, 341 | GFR-creatinine adjusted, Week 48, n=326,335 |
---|
DTG + 3TC-Double Blind Phase | 4.4 | 7.0 | -13.5 | -12.1 |
,DTG + TDF/FTC-Double Blind Phase | 2.2 | 4.1 | -16.7 | -15.6 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C and Serum Retinol Binding Protein (RBP). Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Milligrams per Liter (mg/L) (Mean) |
---|
| Serum Cystatin C, Week 24, n=338, 336 | Serum Cystatin C, Week 48, n=324, 332 | Serum RBP, Week 24, n=332, 334 | Serum RBP, Week 48, n=322, 332 |
---|
DTG + 3TC-Double Blind Phase | -0.05 | -0.07 | 1.6 | 0.5 |
,DTG + TDF/FTC-Double Blind Phase | -0.03 | -0.04 | 1.9 | 0.6 |
[back to top]
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
| Serum or Plasma Creatinine, Week 24, n=340, 343 | Serum or Plasma Creatinine, Week 48, n=326, 335 |
---|
DTG + 3TC-Double Blind Phase | 11.88 | 10.39 |
,DTG + TDF/FTC-Double Blind Phase | 15.07 | 13.61 |
[back to top]
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 144, | HDL Cholesterol, Direct, Week 144 | LDL Cholesterol, Week 144, | Triglycerides, Week 144 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.367 | 0.181 | 0.170 | 0.117 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.037 | 0.098 | -0.105 | -0.104 |
[back to top]
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Mean) |
---|
| Week 4, n=349, 348 | Week 24, n=352, 350 | Week 48, n=352, 350 |
---|
DTG + 3TC-Double Blind Phase | 2.3 | 3.7 | 4.3 |
,DTG + TDF/FTC-Double Blind Phase | 1.2 | 3.2 | 2.8 |
[back to top]
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 96, n=296, 317 | Serum Osteocalcin, Week 96, n=297, 320 | PINP, Week 96, n=297, 319 | CTX-1, Week 96, n=297, 315 |
---|
DTG + 3TC-Double Blind Phase | 0.30 | 0.40 | 15.0 | 0.1351 |
,DTG + TDF/FTC-Double Blind Phase | 2.37 | 4.57 | 28.3 | 0.2943 |
[back to top]
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 144, n=281, 295 | Serum Osteocalcin, Week 144, n=281, 299 | PINP, Week 144, n=281,299 | CTX-1, Week 144, n=281, 296 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.25 | 0.29 | 4.6 | 0.0750 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.43 | 3.21 | 13.8 | 0.2164 |
[back to top]
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 24, n=334, 332 | Bone-ALP, Week 48, n=321, 331 | Serum Osteocalcin, Week 24, n=335, 334 | Serum Osteocalcin, Week 48, n=322, 330 | PINP, Week 24, n=337, 336 | PINP, Week 48, n=321, 334 | CTX-1, Week 24, n=337, 334 | CTX-1, Week 48, n=323, 331 |
---|
DTG + 3TC-Double Blind Phase | 0.91 | 1.21 | 2.56 | 0.78 | 4.5 | 0.5 | 0.1192 | 0.1338 |
,DTG + TDF/FTC-Double Blind Phase | 3.13 | 3.79 | 6.74 | 6.01 | 18.3 | 13.1 | 0.2820 | 0.3352 |
[back to top]
Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment (Day 1). Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831673)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
| Serum Vitamin D, Week 24, n=337, 337 | Serum Vitamin D, Week 48, n=322, 333 |
---|
DTG + 3TC-Double Blind Phase | 5.9 | -3.1 |
,DTG + TDF/FTC-Double Blind Phase | 12.4 | 3.1 |
[back to top]
CD4+ Cell Counts at Weeks 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. (NCT02831673)
Timeframe: Weeks 24 and 48
Intervention | Cells per cubic millimeter (cells/mm^3) (Mean) |
---|
| Week 24, n=340,341 | Week 48, n=324,334 |
---|
DTG + 3TC Double Blind Phase | 655.3 | 687.7 |
,DTG + TDF/FTC-Double Blind Phase | 632.8 | 675.3 |
[back to top]
Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831673)
Timeframe: Up to Week 144
Intervention | Days (Median) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 29.0 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 29.0 |
[back to top]
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 90 |
DTG + TDF/FTC-Double Blind Phase | 93 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 84 |
DTG + TDF/FTC-Double Blind Phase | 89 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 92 |
DTG + TDF/FTC-Double Blind Phase | 93 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 79 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 83 |
[back to top]
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment (Day 1) and change from Baseline=post-dose value minus Baseline value. (NCT02831673)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Mean) |
---|
| Week 4, n=349, 348 | Week 24, n=352, 351 | Week 48, n=352, 351 |
---|
DTG + 3TC-Double Blind Phase | 0.0130 | 0.0131 | 0.0134 |
,DTG + TDF/FTC-Double Blind Phase | 0.0078 | 0.0168 | 0.0129 |
[back to top]
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded to the nearest whole digit. (NCT02831673)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC-Double Blind Phase | 5 |
DTG + TDF/FTC-Double Blind Phase | 4 |
[back to top]
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine, Week 96, n=239, 243 | Urine B2M/Urine Creatinine, Week 96, n=101, 96 | Urine Phosphate, Week 96, n=316, 322 | Urine Protein/Creatinine, Week 96, n=251, 261 | Urine RBP 4/Urine Creatinine, Week 96, n=314, 318 |
---|
DTG + 3TC - Double-blind Phase | 0.939 | 0.844 | 1.156 | 0.887 | 1.030 |
,DTG + TDF/FTC - Double-blind Phase | 0.997 | 1.259 | 1.069 | 1.016 | 1.287 |
[back to top]
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Ratio (Geometric Mean) |
---|
| Urine Albumin/Creatinine, Week 144, n=230, 221 | Urine B2M/Urine Creatinine, Week 144, n=108, 93 | Urine Phosphate, Week 144, n=301, 301 | Urine Protein/Creatinine, Week 144, n=236, 246 | Urine RBP 4/Urine Creatinine, Week 144, n=294, 289 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 1.036 | 0.872 | 1.083 | 0.999 | 1.159 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.067 | 1.494 | 1.084 | 1.180 | 1.567 |
[back to top]
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Weeks 24 and 48
Intervention | Percentage of participants (Number) |
---|
| Week 24, n=313, 320 | Week 48, n=324, 332 |
---|
DTG + 3TC - Double-blind Phase | 4 | 4 |
,DTG + TDF/FTC - Double-blind Phase | 0 | 2 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000 c/mL) and Race (White, African American/African heritage (H.), Asian other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count Group-1, <=200,n=32,26 | Baseline CD4+ cell count Group-1, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209, 203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294,282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240, 252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
---|
DTG + 3TC - Double-blind Phase | 78 | 95 | 93 | 94 | 93 | 96 | 94 | 94 | 92 | 95 | 90 | 97 | 89 |
,DTG + TDF/FTC - Double-blind Phase | 92 | 94 | 89 | 95 | 94 | 94 | 91 | 95 | 90 | 95 | 89 | 90 | 93 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count Group-1, <=200,n=32, 26 | Baseline CD4+ cell count Group-1, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209,203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294,282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240, 252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
---|
DTG + 3TC - Double-blind Phase | 78 | 95 | 89 | 94 | 92 | 97 | 89 | 92 | 97 | 96 | 80 | 97 | 86 |
,DTG + TDF/FTC - Double-blind Phase | 96 | 94 | 87 | 95 | 94 | 94 | 94 | 95 | 90 | 96 | 86 | 90 | 90 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=32, 26 | Baseline CD4+ cell count, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209, 203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294, 282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240,252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 75 | 85 | 78 | 85 | 83 | 86 | 83 | 84 | 86 | 88 | 65 | 85 | 89 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 69 | 86 | 83 | 85 | 83 | 85 | 88 | 85 | 81 | 87 | 74 | 83 | 79 |
[back to top]
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Serum or Plasma Cholesterol, Week 24, n=298, 310 | Serum or Plasma Cholesterol, Week 48, n=298, 307 | HDL Cholesterol, Direct, Week 24, n=299, 310 | HDL Cholesterol, Direct, Week 48, n=299, 307 | LDL Cholesterol, Week 24, n=298, 309 | LDL Cholesterol, Week 48, n=297, 307 | Triglycerides,Week 24, n=299, 310 | Triglycerides, Week 48, n=299, 307 |
---|
DTG + 3TC - Double-blind Phase | 5.0 | 9.3 | 13.9 | 15.3 | 3.8 | 10.7 | 7.0 | 7.3 |
,DTG + TDF/FTC - Double-blind Phase | -4.5 | -3.3 | 7.2 | 4.0 | -7.8 | -4.1 | 0.5 | -0.3 |
[back to top]
Number of Participants With AEs by Maximum Severity Grades up to Week 148
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. (NCT02831764)
Timeframe: Up to Week 148
Intervention | Participants (Count of Participants) |
---|
| Grade 1 AEs | Grade 2 AEs | Grade 3 AEs | Grade 4 AEs | Grade 5 AEs |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 54 | 211 | 32 | 7 | 2 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 54 | 205 | 43 | 6 | 1 |
[back to top]
Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Weeks 24, 48 and 96
Intervention | Participants (Count of Participants) |
---|
| Week 24 | Week 48 | Week 96 |
---|
DTG + 3TC - Double-blind Phase | 6 | 8 | 10 |
,DTG + TDF/FTC - Double-blind Phase | 4 | 8 | 12 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=259,260 | Baseline plasma HIV-1 RNA,>100000, n=59,67 | Baseline CD4+ cell count,<=200, n=25, 23 | Baseline CD4+ cell count,>200, n=293, 304 | Age group-1, <35,n= 186, 187 | Age group-1, 35 to <50, n=101, 110 | Age group-1, >=50, n=31, 30 | Female, n=44, 40 | Male, n=274, 287 | Race group, White, n=221, 234 | Race group, African Am/African H., n=35, 30 | Race group, Asian, n=31, 27 | Race group, Other, n=31, 36 |
---|
DTG + 3TC - Double-blind Phase | 257.9 | 312.1 | 229.4 | 272.3 | 266.0 | 273.6 | 265.8 | 312.7 | 261.4 | 272.1 | 246.3 | 224.0 | 312.0 |
,DTG + TDF/FTC - Double-blind Phase | 257.5 | 297.4 | 202.9 | 269.4 | 257.7 | 286.8 | 233.1 | 307.6 | 259.3 | 258.3 | 303.7 | 264.0 | 278.9 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 48
Intervention | Cells/mm^3 (Least Squares Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=273,271 | Baseline plasma HIV-1 RNA,>100000, n=64,69 | Baseline CD4+ cell count,<=200, n=28, 25 | Baseline CD4+ cell count,>200, n=309, 315 | Age group-1, <35,n= 193, 191 | Age group-1, 35 to <50, n=112, 117 | Age group-1, >=50, n=32, 32 | Age group-2, <50,n= 305, 308 | Age group-2, >=50, n= 32, 32 | Female, n=48, 41 | Male, n=289, 299 | Race group, White, n=230, 244 | Race group, African Am/African H., n=42, 31 | Race group, Asian, n=33, 27 | Race group, Other, n=32, 38 |
---|
DTG + 3TC - Double-blind Phase | 215.6 | 261.8 | 210.9 | 225.8 | 234.2 | 212.7 | 209.1 | 226.4 | 208.5 | 236.2 | 222.8 | 225.5 | 201.2 | 204.9 | 270.2 |
,DTG + TDF/FTC - Double-blind Phase | 208.7 | 248.7 | 153.2 | 221.7 | 201.7 | 244.2 | 203.9 | 217.8 | 204.1 | 263.6 | 210.0 | 214.2 | 239.0 | 189.3 | 232.6 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 24
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=283,273 | Baseline plasma HIV-1 RNA,>100000, n=66,72 | Baseline CD4+ cell count,<=200, n=29, 26 | Baseline CD4+ cell count,>200, n=320, 319 | Age group, <35,n= 201, 193 | Age group-1, 35 to <50, n=113, 119 | Age group-1, >=50, n=35, 33 | Female, n=52, 42 | Male, n=297, 303 | Race group, White, n=236, 243 | Race group, African Am/African H., n=48, 34 | Race group, Asian, n=33, 28 | Race group, Other, n=32, 40 |
---|
DTG + 3TC - Double-blind Phase | 186.01 | 193.90 | 167.95 | 189.91 | 190.12 | 180.50 | 198.74 | 213.58 | 183.41 | 186.48 | 195.18 | 154.03 | 222.21 |
,DTG + TDF/FTC - Double-blind Phase | 148.21 | 220.71 | 106.23 | 167.35 | 151.13 | 190.40 | 133.21 | 153.92 | 164.18 | 167.44 | 151.93 | 141.24 | 160.20 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48
Intervention | Cells/mm^3 (Least Squares Mean) |
---|
| Week 24, n=349, 345 | Week 48, n=337, 340 |
---|
DTG + 3TC - Double-blind Phase | 188.8 | 225.7 |
,DTG + TDF/FTC - Double-blind Phase | 163.2 | 217.2 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Cells/mm^3 (Mean) |
---|
| Baseline plasma HIV-1 RNA,<=100000, n=241,234 | Baseline plasma HIV-1 RNA,>100000, n=55,58 | Baseline CD4+ cell count,<=200, n=25, 19 | Baseline CD4+ cell count,>200, n=271, 273 | Age group, <35,n=171, 159 | Age group-1, 35 to <50, n=95, 103 | Age group-1, >=50, n=30, 30 | Female, n=40, 37 | Male, n=256, 255 | Race group, White, n=202, 211 | Race group, African Am/African H., n=34, 24 | Race group, Asian, n=29, 25 | Race group, Other, n=31, 32 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 286.8 | 338.2 | 264.8 | 300.3 | 302.9 | 292.8 | 274.1 | 355.0 | 287.7 | 300.0 | 256.4 | 258.5 | 355.0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 277.8 | 354.7 | 208.9 | 297.9 | 277.1 | 329.2 | 250.0 | 381.8 | 279.6 | 296.5 | 377.6 | 245.4 | 240.7 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Milliliter/minute/1.73 meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 96, n=316,326 | GFR creatinine adjusted, Week 96, n=315,325 |
---|
DTG + 3TC - Double-blind Phase | 9.1 | -14.2 |
,DTG + TDF/FTC - Double-blind Phase | 9.5 | -17.5 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Milliliter/minute/1.73 meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 144, n=301,304 | GFR creatinine adjusted, Week 144, n=292,292 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 10.3 | -15.5 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 10.1 | -18.2 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48
Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Milliliter/minute/1.73 meter^2 (Mean) |
---|
| GFR Cystatin C adjusted, Week 24, n=345,345 | GFR Cystatin C adjusted, Week 48, n=335,336 | GFR creatinine adjusted, Week 24, n=346,344 | GFR creatinine adjusted, Week 48, n=335, 337 |
---|
DTG + 3TC - Double-blind Phase | 3.8 | 5.4 | -12.0 | -12.1 |
,DTG + TDF/FTC - Double-blind Phase | 0.2 | 3.6 | -15.4 | -15.4 |
[back to top]
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Milligrams per Liter (mg/L) (Least Squares Mean) |
---|
| Serum Cystatin C, Week 24, n=345,345 | Serum Cystatin C, Week 48, n=335,336 | Serum RBP, Week 24, n=345,343 | Serum RBP, Week 48, n=334, 334 |
---|
DTG + 3TC - Double-blind Phase | -0.04 | -0.05 | 1.2 | 0.6 |
,DTG + TDF/FTC - Double-blind Phase | 0.00 | -0.04 | 1.4 | -0.1 |
[back to top]
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
| Serum or Plasma Creatinine, Week 24, n=346, 344 | Serum or Plasma Creatinine, Week 48, n=335, 337 |
---|
DTG + 3TC - Double-blind Phase | 10.51 | 10.32 |
,DTG + TDF/FTC - Double-blind Phase | 13.53 | 13.44 |
[back to top]
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 96, n=270, 289 | HDL Cholesterol, Direct, Week 96, n=271, 289 | LDL Cholesterol, Week 96, n=270, 289 | Triglycerides, Week 96, n=271, 289 |
---|
DTG + 3TC - Double-blind Phase | 0.345 | 0.185 | 0.139 | 0.105 |
,DTG + TDF/FTC - Double-blind Phase | -0.132 | 0.071 | -0.160 | -0.102 |
[back to top]
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144
Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Millimoles per liter (Mean) |
---|
| Serum or Plasma Cholesterol, Week 144, n=263, 278 | HDL Cholesterol, Direct, Week 144, n=264, 278 | LDL Cholesterol, Week 144, n=263, 278 | Triglycerides, Week 144, n=264, 278 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.360 | 0.180 | 0.143 | 0.078 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.015 | 0.093 | -0.085 | -0.057 |
[back to top]
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4, n=358, 355 | Week 24, n=359, 358 | Week 48, n=359, 358 |
---|
DTG + 3TC - Double-blind Phase | 1.8 | 3.9 | 4.0 |
,DTG + TDF/FTC - Double-blind Phase | 3.1 | 4.5 | 4.6 |
[back to top]
Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and Weeks 4, 24, 48
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Week 4, n=359, 355 | Week 24, n=360, 358 | Week 48, n=360, 358 |
---|
DTG + 3TC - Double-blind Phase | 0.0111 | 0.0207 | 0.0189 |
,DTG + TDF/FTC - Double-blind Phase | 0.0130 | 0.0203 | 0.0208 |
[back to top]
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 96, n=315, 326 | Serum Osteocalcin, Week 96, n=315, 326 | PINP, Week 96, n=315, 325 | CTX-1, Week 96, n=311, 318 |
---|
DTG + 3TC - Double-blind Phase | 0.26 | 0.13 | 7.0 | 0.0604 |
,DTG + TDF/FTC - Double-blind Phase | 2.39 | 3.90 | 19.5 | 0.1787 |
[back to top]
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 144, n=302, 305 | Serum Osteocalcin, Week 144, n=300, 304 | PINP, Week 144, n=299, 300 | CTX-1, Week 144, n=291, 298 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.25 | -1.02 | -0.1 | 0.0505 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.88 | 2.87 | 9.4 | 0.1868 |
[back to top]
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Micrograms per Liter (ug/L) (Mean) |
---|
| Bone-ALP, Week 24, n=345, 346 | Bone-ALP, Week 48, n=334, 337 | Serum Osteocalcin, Week 24, n=345, 346 | Serum Osteocalcin, Week 48, n=335, 336 | PINP, Week 24, n=344, 346 | PINP, Week 48, n=335, 337 | CTX-1, Week 24, n=342, 342 | CTX-1, Week 48, n=332, 333 |
---|
DTG + 3TC - Double-blind Phase | 0.72 | 1.24 | 2.13 | 0.40 | 1.7 | 0.4 | 0.1541 | 0.1345 |
,DTG + TDF/FTC - Double-blind Phase | 3.38 | 4.33 | 6.80 | 6.30 | 15.2 | 13.3 | 0.2812 | 0.3388 |
[back to top]
Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Weeks 24, 48
Intervention | Nanomoles per Liter (nmol/L) (Least Squares Mean) |
---|
| Serum Vitamin D, Week 24, n=346, 344 | Serum Vitamin D, Week 48, n=336, 335 |
---|
DTG + 3TC - Double-blind Phase | 11.2 | 0.3 |
,DTG + TDF/FTC - Double-blind Phase | 15.4 | 0.4 |
[back to top]
CD4+ Cell Counts at Weeks 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Weeks 24 and 48
Intervention | Cells/mm^3 (Mean) |
---|
| Week 24, n=349,345 | Week 48, n=337,340 |
---|
DTG + 3TC - Double-blind Phase | 650.4 | 688.1 |
,DTG + TDF/FTC - Double-blind Phase | 633.0 | 689.8 |
[back to top]
Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144
Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Days (Median) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 29.0 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 29.0 |
[back to top]
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 93 |
DTG + TDF/FTC - Double-blind Phase | 94 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 88 |
DTG + TDF/FTC - Double-blind Phase | 90 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 24
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 94 |
DTG + TDF/FTC - Double-blind Phase | 94 |
[back to top]
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144
Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off. (NCT02831764)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 84 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 84 |
[back to top]
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase | 6 |
DTG + TDF/FTC - Double-blind Phase | 2 |
[back to top]
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144
Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 144
Intervention | Percentage of participants (Number) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 6 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4 |
[back to top]
Number of Participants Who Discontinue Treatment Due to AEs Over Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 13 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 16 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 96
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase | 272.0 |
DTG + TDF/FTC - Double-blind Phase | 264.6 |
[back to top]
Changes From Baseline in CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Week 144
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 301.7 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 296.6 |
[back to top]
Change From Baseline in Renal Biomarker-Serum RBP at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC - Double-blind Phase | 0.557 |
DTG + TDF/FTC - Double-blind Phase | 2.483 |
[back to top]
Change From Baseline in Renal Biomarker-Serum RBP at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Microgram per millimoles (ug/mmol) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.560 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 3.813 |
[back to top]
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase | 11.71 |
DTG + TDF/FTC - Double-blind Phase | 14.75 |
[back to top]
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144
Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error has been presented. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Micromoles per Liter (umol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 12.28 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 15.14 |
[back to top]
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | mg/L (Mean) |
---|
DTG + 3TC - Double-blind Phase | -0.09 |
DTG + TDF/FTC - Double-blind Phase | -0.08 |
[back to top]
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144
Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | mg/L (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.11 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.08 |
[back to top]
[back to top]
Number of Participants With HIV-1 Disease Progression up to Week 144
HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. Participants may have more than one indicators of clinical disease progression including death, hence they may contribute to data in more than one categories. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| No disease progression | From CDC Stage 1 to CDC Stage 3 Event | From CDC Stage 2 to CDC Stage 3 Event | From CDC Stage 3 to New CDC Stage 3 Event | From CDC Stage 1, 2 or 3 to Death |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 356 | 0 | 2 | 1 | 2 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 357 | 0 | 1 | 0 | 1 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| ALT, Grades 1 to 4 | ALT, Grades 2 to 4 | ALT, Grades 3 to 4 | ALT, Grade 1 | ALT, Grade 2 | ALT, Grade 3 | ALT, Grade 4 | Albumin, Grades 1 to 4 | Albumin, Grades 2 to 4 | Albumin, Grades 3 to 4 | Albumin, Grade 1 | Albumin, Grade 2 | Albumin, Grade 3 | Albumin, Grade 4 | ALP, Grades 1 to 4 | ALP, Grades 2 to 4 | ALP, Grades 3 to 4 | ALP, Grade 1 | ALP, Grade 2 | ALP, Grade 3 | ALP, Grade 4 | AST, Grades 1 to 4 | AST, Grades 2 to 4 | AST, Grades 3 to 4 | AST, Grade 1 | AST, Grade 2 | AST, Grade 3 | AST, Grade 4 | Bilirubin, Grades 1 to 4 | Bilirubin, Grades 2 to 4 | Bilirubin, Grades 3 to 4 | Bilirubin, Grade 1 | Bilirubin, Grade 2 | Bilirubin, Grade 3 | Bilirubin, Grade 4 | CO2, Grades 1 to 4 | CO2, Grades 2 to 4 | CO2, Grades 3 to 4 | CO2, Grade 1 | CO2, Grade 2 | CO2, Grade 3 | CO2, Grade 4 | Cholesterol, Grades 1 to 4 | Cholesterol, Grades 2 to 4 | Cholesterol, Grades 3 to 4 | Cholesterol, Grade 1 | Cholesterol, Grade 2 | Cholesterol, Grade 3 | Cholesterol, Grade 4 | CK, Grades 1 to 4 | CK, Grades 2 to 4 | CK, Grades 3 to 4 | CK, Grade 1 | CK, Grade 2 | CK, Grade 3 | CK, Grade 4 | Creatinine, Grades 1 to 4 | Creatinine, Grades 2 to 4 | Creatinine, Grades 3 to 4 | Creatinine, Grade 1 | Creatinine, Grade 2 | Creatinine, Grade 3 | Creatinine, Grade 4 | Direct Bilirubin, Grades 1 to 4 | Direct Bilirubin, Grades 2 to 4 | Direct Bilirubin, Grades 3 to 4 | Direct Bilirubin, Grade 1 | Direct Bilirubin, Grade 2 | Direct Bilirubin, Grade 3 | Direct Bilirubin, Grade 4 | GFR, Grades 1 to 4 | GFR, Grades 2 to 4 | GFR, Grades 3 to 4 | GFR, Grade 1 | GFR, Grade 2 | GFR, Grade 3 | GFR, Grade 4 | Hypercalcaemia, Grades 1 to 4 | Hypercalcaemia, Grades 2 to 4 | Hypercalcaemia, Grades 3 to 4 | Hypercalcemia, Grade 1 | Hypercalcaemia, Grade 2 | Hypercalcaemia, Grade 3 | Hypercalcaemia, Grade 4 | Hyperglycaemia, Grades 1 to 4 | Hyperglycaemia, Grades 2 to 4 | Hyperglycaemia, Grades 3 to 4 | Hyperglycaemia, Grade 1 | Hyperglycaemia, Grade 2 | Hyperglycaemia, Grade 3 | Hyperglycaemia, Grade 4 | Hyperkalemia, Grades 1 to 4 | Hyperkalemia, Grades 2 to 4 | Hyperkalemia, Grades 3 to 4 | Hyperkalemia, Grade 1 | Hyperkalemia, Grade 2 | Hyperkalemia, Grade 3 | Hyperkalemia, Grade 4 | Hypernatremia, Grades 1 to 4 | Hypernatremia, Grades 2 to 4 | Hypernatremia, Grades 3 to 4 | Hypernatremia, Grade 1 | Hypernatremia, Grade 2 | Hypernatremia, Grade 3 | Hypernatremia, Grade 4 | Hypocalcaemia, Grades 1 to 4 | Hypocalcaemia, Grades 2 to 4 | Hypocalcaemia, Grades 3 to 4 | Hypocalcaemia, Grade 1 | Hypocalcaemia, Grade 2 | Hypocalcaemia, Grade 3 | Hypocalcaemia, Grade 4 | Hypoglycaemia, Grades 1 to 4 | Hypoglycaemia, Grades 2 to 4 | Hypoglycaemia, Grades 3 to 4 | Hypoglycaemia, Grade 1 | Hypoglycaemia, Grade 2 | Hypoglycaemia, Grade 3 | Hypoglycaemia, Grade 4 | Hypokalemia, Grades 1 to 4 | Hypokalemia, Grades 2 to 4 | Hypokalemia, Grades 3 to 4 | Hypokalemia, Grade 1 | Hypokalemia, Grade 2 | Hypokalemia, Grade 3 | Hypokalemia, Grade 4 | Hyponatremia, Grades 1 to 4 | Hyponatremia, Grades 2 to 4 | Hyponatremia, Grades 3 to 4 | Hyponatremia, Grade 1 | Hyponatremia, Grade 2 | Hyponatremia, Grade 3 | Hyponatremia, Grade 4 | LDL Cholesterol, Grades 1 to 4 | LDL Cholesterol, Grades 2 to 4 | LDL Cholesterol, Grades 3 to 4 | LDL Cholesterol, Grade 1 | LDL Cholesterol, Grade 2 | LDL Cholesterol, Grade 3 | LDL Cholesterol, Grade 4 | Lactate Dehydrogenase, Grades 1 to 4 | Lactate Dehydrogenase, Grades 2 to 4 | Lactate Dehydrogenase, Grades 3 to 4 | Lactate Dehydrogenase, Grade 1 | Lactate Dehydrogenase, Grade 2 | Lactate Dehydrogenase, Grade 3 | Lactate Dehydrogenase, Grade 4 | Lipase, Grades 1 to 4 | Lipase, Grades 2 to 4 | Lipase, Grades 3 to 4 | Lipase, Grade 1 | Lipase, Grade 2 | Lipase, Grade 3 | Lipase, Grade 4 | Phosphate, Grades 1 to 4 | Phosphate, Grades 2 to 4 | Phosphate, Grades 3 to 4 | Phosphate, Grade 1 | Phosphate, Grade 2 | Phosphate, Grade 3 | Phosphate, Grade 4 | Triglycerides, Grades 1 to 4 | Triglycerides, Grades 2 to 4 | Triglycerides, Grades 3 to 4 | Triglycerides, Grade 1 | Triglycerides, Grade 2 | Triglycerides, Grade 3 | Triglycerides, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 77 | 30 | 13 | 47 | 17 | 6 | 7 | 2 | 2 | 0 | 0 | 2 | 0 | 0 | 10 | 2 | 0 | 8 | 2 | 0 | 0 | 71 | 30 | 15 | 41 | 15 | 8 | 7 | 46 | 13 | 4 | 33 | 9 | 0 | 4 | 111 | 10 | 0 | 101 | 10 | 0 | 0 | 98 | 23 | 1 | 75 | 22 | 1 | 0 | 91 | 49 | 29 | 42 | 20 | 11 | 18 | 18 | 5 | 0 | 13 | 5 | 0 | 0 | 11 | 11 | 11 | 0 | 0 | 11 | 0 | 198 | 198 | 20 | 0 | 178 | 20 | 0 | 4 | 0 | 0 | 4 | 0 | 0 | 0 | 106 | 49 | 3 | 57 | 46 | 2 | 1 | 7 | 2 | 1 | 5 | 1 | 0 | 1 | 4 | 1 | 0 | 3 | 1 | 0 | 0 | 17 | 6 | 1 | 11 | 5 | 1 | 0 | 22 | 6 | 4 | 16 | 2 | 3 | 1 | 9 | 0 | 0 | 9 | 0 | 0 | 0 | 23 | 0 | 0 | 23 | 0 | 0 | 0 | 66 | 21 | 6 | 45 | 15 | 6 | 0 | 4 | 3 | 0 | 1 | 3 | 0 | 0 | 72 | 37 | 9 | 35 | 28 | 6 | 3 | 75 | 50 | 7 | 25 | 43 | 7 | 0 | 89 | 22 | 4 | 67 | 18 | 4 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 71 | 29 | 15 | 42 | 14 | 8 | 7 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 17 | 3 | 1 | 14 | 2 | 1 | 0 | 83 | 32 | 14 | 51 | 18 | 11 | 3 | 56 | 16 | 3 | 40 | 13 | 2 | 1 | 111 | 4 | 0 | 107 | 4 | 0 | 0 | 50 | 12 | 0 | 38 | 12 | 0 | 0 | 83 | 47 | 28 | 36 | 19 | 11 | 17 | 28 | 2 | 1 | 26 | 1 | 1 | 0 | 10 | 10 | 10 | 0 | 0 | 10 | 0 | 219 | 219 | 29 | 0 | 190 | 28 | 1 | 5 | 1 | 1 | 4 | 0 | 0 | 1 | 86 | 38 | 3 | 48 | 35 | 2 | 1 | 7 | 1 | 1 | 6 | 0 | 1 | 0 | 7 | 0 | 0 | 7 | 0 | 0 | 0 | 21 | 11 | 3 | 10 | 8 | 2 | 1 | 21 | 5 | 1 | 16 | 4 | 0 | 1 | 5 | 1 | 0 | 4 | 1 | 0 | 0 | 22 | 3 | 1 | 19 | 2 | 0 | 1 | 40 | 13 | 2 | 27 | 11 | 2 | 0 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 81 | 43 | 17 | 38 | 26 | 13 | 4 | 78 | 51 | 7 | 27 | 44 | 7 | 0 | 75 | 15 | 1 | 60 | 14 | 1 | 0 |
[back to top]
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144
Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelet count. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| Hemoglobin, Grades 1 to 4 | Hemoglobin, Grades 2 to 4 | Hemoglobin, Grades 3 to 4 | Hemoglobin, Grade 1 | Hemoglobin, Grade 2 | Hemoglobin, Grade 3 | Hemoglobin, Grade 4 | Leukocytes, Grades 1 to 4 | Leukocytes, Grades 2 to 4 | Leukocytes, Grades 3 to 4 | Leukocytes, Grade 1 | Leukocytes, Grade 2 | Leukocytes, Grade 3 | Leukocytes, Grade 4 | Neutrophils, Grades 1 to 4 | Neutrophils, Grades 2 to 4 | Neutrophils, Grades 3 to 4 | Neutrophils, Grade 1 | Neutrophils, Grade 2 | Neutrophils, Grade 3 | Neutrophils, Grade 4 | Platelets, Grades 1 to 4 | Platelets, Grades 2 to 4 | Platelets, Grades 3 to 4 | Platelets, Grade 1 | Platelets, Grade 2 | Platelets, Grade 3 | Platelets, Grade 4 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 8 | 6 | 2 | 2 | 4 | 1 | 1 | 5 | 1 | 0 | 4 | 1 | 0 | 0 | 23 | 8 | 4 | 15 | 4 | 2 | 2 | 13 | 5 | 0 | 8 | 5 | 0 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 10 | 6 | 1 | 4 | 5 | 1 | 0 | 5 | 0 | 0 | 5 | 0 | 0 | 0 | 7 | 3 | 1 | 4 | 2 | 1 | 0 | 9 | 5 | 0 | 4 | 5 | 0 | 0 |
[back to top]
Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144
Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI Mutations | Major mutations of the NRTI |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0 | 0 |
[back to top]
Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol-defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. (NCT02831764)
Timeframe: Up to Week 148
Intervention | Participants (Count of Participants) |
---|
| Any AE | Any SAE |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 306 | 39 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 309 | 47 |
[back to top]
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 96
Intervention | Ratio (Mean) |
---|
DTG + 3TC - Double-blind Phase | -0.113 |
DTG + TDF/FTC - Double-blind Phase | -0.395 |
[back to top]
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96
Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off. (NCT02831764)
Timeframe: Week 96
Intervention | Percentage of participants (Number) |
---|
| Baseline CD4+ cell count, <=200,n=32, 26 | Baseline CD4+ cell count, >200,n=328,333 | Female, n=54, 46 | Male, n=306, 313 | Age, <35,n= 209, 203 | Age, 35 to <50,n=115, 122 | Age, >=50, n=36, 34 | Baseline plasma HIV-1 RNA, <=100000,n=294, 282 | Baseline plasma HIV-1 RNA, >100000,n=66, 77 | Race, White, n=240,252 | Race, African American/African H., n=51, 35 | Race, Asian, n=34, 30 | Race, Other, n=35, 42 |
---|
DTG + 3TC - Double-blind Phase | 72 | 89 | 81 | 89 | 88 | 90 | 83 | 88 | 86 | 92 | 69 | 88 | 89 |
,DTG + TDF/FTC - Double-blind Phase | 85 | 90 | 85 | 90 | 91 | 89 | 88 | 91 | 84 | 91 | 86 | 90 | 83 |
[back to top]
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and at Week 144
Intervention | Ratio (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | -0.245 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | -0.359 |
[back to top]
CD4+ Cell Counts at Week 96
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 96
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase | 734.9 |
DTG + TDF/FTC - Double-blind Phase | 739.9 |
[back to top]
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48
Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor. (NCT02831764)
Timeframe: Baseline and Weeks 24, 48
Intervention | Ratio (Geometric Mean) |
---|
| Serum B2M, Week 24, n=344,346 | Serum B2M, Week 48, n=335,336 | Urine B2M, Week 24, n=124,106 | Urine B2M, Week 48, n=109, 103 | Urine Albumin/Creatinine, Week 24, n=259, 251 | Urine Albumin/Creatinine , Week 48, n=249, 240 | Urine B2M/Urine Creatinine , Week 24, n=122, 104 | Urine B2M/Urine Creatinine , Week 48, n=108, 103 | Urine Phosphate, Week 24, n=343, 340 | Urine Phosphate, Week 48, n=335, 332 | Urine Protein/Creatinine, Week 24, n=263,279 | Urine Protein/Creatinine , Week 48, n=259, 261 | Urine RBP 4, Week 24, n=340, 338 | Urine RBP 4, Week 48, n=333, 331 | Urine RBP 4/Urine Creatinine, Week 24, n=338, 335 | Urine RBP 4/Urine Creatinine, Week 48, n=331, 328 |
---|
DTG + 3TC - Double-blind Phase | 0.809 | 0.811 | 0.844 | 0.917 | 0.907 | 0.911 | 0.880 | 0.969 | 1.041 | 1.121 | 0.818 | 0.866 | 0.656 | 0.740 | 0.670 | 0.749 |
,DTG + TDF/FTC - Double-blind Phase | 0.882 | 0.887 | 1.129 | 1.323 | 1.021 | 0.971 | 1.126 | 1.307 | 1.063 | 1.056 | 0.991 | 1.007 | 0.824 | 0.819 | 0.811 | 0.844 |
[back to top]
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144
Number of participants, who met CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (DTG, 3TC, Abacavir [ABC], elvitegravir [EGV], raltegravir [RAL], zidovudine [AZT], stavudine [D4T], didanosine [DDI]), emtricitabine [FTC], tenofovir disiproxil fumarate [TDF]). Partially sensitive and resistant cells were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. (NCT02831764)
Timeframe: Up to Week 144
Intervention | Participants (Count of Participants) |
---|
| INSTI, DTG, Sensitive, n=7,2 | INSTI, DTG, Resistant, n=7,2 | INSTI, EGV, Sensitive, n=7,2 | INSTI, EGV, Resistant, n=7,2 | INSTI, RAL, Sensitive, n=7,2 | INSTI, RAL, Resistant, n=7,2 | NRTI, 3TC, Sensitive, n=7,3 | NRTI, 3TC, Resistant, n=7,3 | NRTI, ABC, Sensitive, n=7,3 | NRTI, ABC, Resistant, n=7,3 | NRTI, AZT, Sensitive, n=7,3 | NRTI, AZT, Resistant, n=7,3 | NRTI, D4T, Sensitive, n=7,3 | NRTI, D4T, Resistant, n=7,3 | NRTI, DDI, Sensitive, n=7,3 | NRTI, DDI, Resistant, n=7,3 | NRTI, FTC, Sensitive, n=7,3 | NRTI, FTC, Resistant, n=7,3 | NRTI, TDF, Sensitive, n=7,3 | NRTI, TDF, Resistant, n=7,3 |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 | 7 | 0 |
,DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 2 | 0 | 2 | 0 | 2 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 | 3 | 0 |
[back to top]
CD4+ Cell Counts at Week 144
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. (NCT02831764)
Timeframe: Week 144
Intervention | Cells/mm^3 (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 763.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 770.4 |
[back to top]
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 144
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 1.1 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 1.4 |
[back to top]
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96
Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. (NCT02831764)
Timeframe: Baseline and at Week 96
Intervention | Nanomoles per Liter (nmol/L) (Mean) |
---|
DTG + 3TC - Double-blind Phase | -1.7 |
DTG + TDF/FTC - Double-blind Phase | 1.3 |
[back to top]
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 4.8 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 4.5 |
[back to top]
Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48
Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). Lipid last observation carried forwarded (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded. (NCT02831764)
Timeframe: Baseline (Day 1) and at Weeks 24, 48
Intervention | Percentage change (Mean) |
---|
| Total/HDL Cholesterol Ratio, Week 24, n=298, 310 | Total/HDL Cholesterol Ratio, Week 48, n=298, 307 |
---|
DTG + 3TC - Double-blind Phase | -4.4 | -2.8 |
,DTG + TDF/FTC - Double-blind Phase | -7.5 | -4.5 |
[back to top]
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96
EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase | 4.4 |
DTG + TDF/FTC - Double-blind Phase | 5.1 |
[back to top]
Change From Baseline in EQ-5D-5L Utility Score at Week 144
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 144
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase + Open-label Phase | 0.0210 |
DTG + TDF/FTC - Double-blind Phase + Open-label Phase | 0.0131 |
[back to top]
Change From Baseline in EQ-5D-5L Utility Score at Week 96
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Adjusted mean and standard error is presented. (NCT02831764)
Timeframe: Baseline (Day 1) and Week 96
Intervention | Scores on a scale (Mean) |
---|
DTG + 3TC - Double-blind Phase | 0.0168 |
DTG + TDF/FTC - Double-blind Phase | 0.0171 |
[back to top]
HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
"Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.~Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)" (NCT02859558)
Timeframe: At week 48
Intervention | Percentage of CD4+ T-cells (Median) |
---|
| CD4+ T-cell Response to Env | CD4+ T-cell Response to Gag | CD4+ T-cell Response to Nef | CD4+ T-cell Response to Pol |
---|
Arm 1: Fiebig I/II | 0.00 | 0.06 | 0.04 | 0.00 |
,Arm 2: Fiebig III/IV | 0.00 | 0.19 | 0.10 | 0.04 |
,Arm 3: Fiebig V | 0.08 | 0.14 | 0.10 | 0.04 |
[back to top]
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed. (NCT02859558)
Timeframe: At week 48
Intervention | Proportion of participants (Number) |
---|
| Joint Assay (Integrase + Gag) | Integrase Assay | Gag Assay |
---|
Arm 1: Fiebig I/II | 0.00 | 0.10 | 0.03 |
,Arm 2: Fiebig III/IV | 0.00 | 0.06 | 0.02 |
,Arm 3: Fiebig V | 0.00 | 0.10 | 0.00 |
[back to top]
HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
"Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero.~Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)" (NCT02859558)
Timeframe: At 48 weeks
Intervention | Percentage of CD8+ T-cells (Median) |
---|
| CD8+ T-cell Response to Env | CD8+ T-cell Response to Gag | CD8+ T-cell Response to Nef | CD8+ T-cell Response to Pol |
---|
Arm 1: Fiebig I/II | 0.00 | 0.15 | 0.03 | 0.00 |
,Arm 2: Fiebig III/IV | 0.00 | 0.33 | 0.15 | 0.05 |
,Arm 3: Fiebig V | 0.00 | 0.28 | 0.33 | 0.08 |
[back to top]
Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed. (NCT02859558)
Timeframe: At week 0
Intervention | Proportion of participants (Number) |
---|
| Joint Assay (Integrase + Gag) | Integrase Assay | Gag Assay |
---|
Arm 1: Fiebig I/II | 0.00 | 0.04 | 0.00 |
,Arm 2: Fiebig III/IV | 0.01 | 0.03 | 0.01 |
,Arm 3: Fiebig V | 0.00 | 0.07 | 0.00 |
[back to top]
Steady State Concentrations of TFV-DP for Different Dosing Patterns of Descovy
Tenofovir diphosphate (TFV-DP) concentrations in dried blood spots (DBS) respective to dosing regimens of 33%, 67%, 100% of daily dosing. (NCT02962739)
Timeframe: Assessed weekly for 9 months
Intervention | fmol/punch (Mean) |
---|
DOT 33% | 657 |
DOT 67% | 1451 |
DOT 100% | 2381 |
[back to top]
Peak Plasma Concentration (Cmax)
Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology. (NCT02968576)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Intervention | ng/mL (Geometric Mean) |
---|
| TFV Cmax-unencapsulated | TFV Cmax-coencapsulated | FTC Cmax-unencapsulated | FTC Cmax-coencapsulated |
---|
All Participants | 222 | 229 | 1567 | 1684 |
[back to top]
Area Under the Concentration-time Curve (AUC)
Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology. (NCT02968576)
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose
Intervention | ng*h/mL (Geometric Mean) |
---|
| TFV AUC-unencapsulated | TFV AUC-coencapsulated | FTC AUC-unencapsulated | FTC AUC-coencapsulated |
---|
All Participants | 1978 | 2042 | 9342 | 9512 |
[back to top]
Time to First HIV-1 RNA Less Than 200 Copies/mL Through Delivery
Time to first viral HIV-1 RNA less than 200 copies/mL through delivery, determined using real-time results obtained from site laboratories (NCT03048422)
Timeframe: Randomization to delivery
Intervention | weeks (Mean) |
---|
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 4.26 |
Arm 3: Maternal EFV/FTC/TDF | 6.49 |
[back to top]
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at Delivery Based on FDA Snapshot Algorithm
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at delivery based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: Delivery
Intervention | percentage of participants (Number) |
---|
Arm 1: Maternal DTG+FTC/TAF | 88.9 |
Arm 2: Maternal DTG+FTC/TDF | 92.6 |
Arm 3: Maternal EFV/FTC/TDF | 81.0 |
[back to top]
Percentage of Mothers With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum Based on FDA Snapshot Algorithm
Percentage of mothers with virologic success of HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum based on FDA snapshot algorithm using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum
Intervention | percentage of participants (Number) |
---|
Arm 1: Maternal DTG+FTC/TAF | 75.6 |
Arm 2: Maternal DTG+FTC/TDF | 77.7 |
Arm 3: Maternal EFV/FTC/TDF | 76.3 |
[back to top]
Percentage of Mothers With HIV-1 RNA Less Than 50 Copies/mL at Delivery Measured at Central Laboratory
Percentage of mothers with HIV-1 RNA less than 50 copies/mL at delivery using batched test results obtained from central laboratory (NCT03048422)
Timeframe: Delivery
Intervention | percentage of participants (Number) |
---|
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 94.4 |
Arm 3: Maternal EFV/FTC/TDF | 78.8 |
[back to top]
Percentage of Mothers With HIV-1 RNA Less Than 200 Copies/mL at 50 Weeks Postpartum
Percentage of mothers with HIV-1 RNA less than 200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories (NCT03048422)
Timeframe: 50 weeks postpartum
Intervention | percentage of participants (Number) |
---|
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 96.3 |
Arm 3: Maternal EFV/FTC/TDF | 96.4 |
[back to top]
Percentage of Mothers With HIV-1 ARV Drug Resistance Mutations at the Time of Maternal Virologic Failure
Percentage of mothers with HIV-1 antiretroviral (ARV) drug resistance mutations at the time of maternal virologic failure. Virologic failure was defined as two consecutive plasma HIV-1 RNA viral loads <200 copies/mL on or after 24 weeks on study. Drug resistance mutations were assessed using the Stanford algorithm, and all ARV regimens were assessed for mutations. (NCT03048422)
Timeframe: From 24 weeks after randomization through Week 50 postpartum
Intervention | percentage of participants (Number) |
---|
Arm 1: Maternal DTG+FTC/TAF | 0.92 |
Arm 2: Maternal DTG+FTC/TDF | 1.86 |
Arm 3: Maternal EFV/FTC/TDF | 6.16 |
[back to top]
Percentage of Mother-Infant Pairs With Preterm Deliveries
Percentage of mother-infant pairs with preterm deliveries (<37 weeks gestation) resulting in live born infant (NCT03048422)
Timeframe: Delivery
Intervention | percentage of participants (Number) |
---|
Arm 1: Maternal DTG+FTC/TAF | 5.8 |
Arm 2: Maternal DTG+FTC/TDF | 9.4 |
Arm 3: Maternal EFV/FTC/TDF | 12.1 |
[back to top]
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome or Major Congenital Anomaly
Percentage of mother-infant pairs with an adverse pregnancy outcome or major congenital anomaly. Adverse pregnancy outcomes include spontaneous abortions (<20 weeks gestation), stillbirths (≥20 weeks gestation), preterm deliveries (<37 weeks gestation), and infants small for gestational age (<10th percentile per INTERGROWTH 21st Standards). Major congenital anomaly was defined consistent with the definition of malformation provided by Holmes and Westgate (i.e., a structural abnormality with surgical, medical, or cosmetic importance) and evaluated by an internal study team blinded to treatment arm. (NCT03048422)
Timeframe: Delivery through 50 weeks postpartum
Intervention | percentage of mother-infant pairs (Number) |
---|
Arm 1: Maternal DTG+FTC/TAF | 24.1 |
Arm 2: Maternal DTG+FTC/TDF | 32.9 |
Arm 3: Maternal EFV/FTC/TDF | 33.2 |
[back to top]
Percentage of Mother-Infant Pairs With an Adverse Pregnancy Outcome
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile per INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery
Intervention | percentage of mother-infant pairs (Number) |
---|
Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 28.4 |
Arm 3: Maternal EFV/FTC/TDF | 32.7 |
[back to top]
Percentage of Mother-infant Pairs With an Adverse Pregnancy Outcome
Percentage of mother-infant pairs with an adverse pregnancy outcome. Adverse pregnancy outcome includes spontaneous abortion (<20 weeks gestation), stillbirth (≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile by INTERGROWTH 21st Standards) (NCT03048422)
Timeframe: Delivery
Intervention | percentage of mother-infant pairs (Number) |
---|
Arm 1: Maternal DTG+FTC/TAF | 24.1 |
Arm 2: Maternal DTG+FTC/TDF | 32.9 |
Arm 3: Maternal EFV/FTC/TDF | 32.7 |
[back to top]
Percentage of Infants Born Small for Gestational Age
Percentage of infants born small for gestational age (<10th percentile adjusted for sex assigned at birth) based on Intergrowth 21st Standards (NCT03048422)
Timeframe: Birth
Intervention | percentage of participants (Number) |
---|
Arm 1 Infants | 16.3 |
Arm 2 Infants | 22.5 |
Arm 3 Infants | 20.5 |
[back to top]
Maternal Change in Creatinine Clearance
Maternal change in creatinine clearance per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum
Intervention | mL/min (Mean) |
---|
Arm 1: Maternal DTG+FTC/TAF | -0.980 |
Arm 2: Maternal DTG+FTC/TDF | -0.887 |
Arm 3: Maternal EFV/FTC/TDF | -0.935 |
[back to top]
Cumulative Probability of Women Experiencing Grade 3 or Higher Adverse Event
"The Kaplan-Meier estimate of the cumulative probability of women experiencing grade 3 or higher adverse events, including events resulting in death due to any cause.~Time to first maternal grade 3 or higher adverse event was defined as the first grade 3 or higher adverse event that occurred after randomization and before 74 weeks of follow-up. The timeframe of 74 weeks was determined by adding up 56 weeks of postpartum follow-up to the mean duration of antepartum follow-up, which was 18 weeks." (NCT03048422)
Timeframe: From randomization up to 74 weeks
Intervention | Cumulative probability per 100 persons (Number) |
---|
Arm 1: Maternal DTG+FTC/TAF | 25.1 |
Arm 2: Maternal DTG+FTC/TDF | 30.8 |
Arm 3: Maternal EFV/FTC/TDF | 27.9 |
,Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 27.9 |
Arm 3: Maternal EFV/FTC/TDF | 27.9 |
[back to top]
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: From birth through Week 50 postpartum
Intervention | Cumulative probability per 100 persons (Number) |
---|
Arm 1 Infants | 25.3 |
Arm 2 Infants | 28.6 |
Arm 3 Infants | 30.9 |
[back to top]
Cumulative Probability of Infants Experiencing Grade 3 or Higher Adverse Event
The Kaplan-Meier estimate of the cumulative probability of infants experiencing grade 3 or higher adverse events, including events resulting in death due to any cause. (NCT03048422)
Timeframe: Birth through Week 50 postpartum
Intervention | Cumulative probability per 100 persons (Number) |
---|
Arms 1 and 2 Infants | 26.8 |
Arm 3 Infants | 30.9 |
[back to top]
Cumulative Probability of Infant HIV-infection
The Kaplan-Meier estimate of the cumulative probability of infants acquiring HIV-1 infection from birth through 50 weeks after birth based on nucleic acid test results. (NCT03048422)
Timeframe: Birth through 50 weeks after birth
Intervention | Cumulative probability per 100 persons (Number) |
---|
Arm 1 Infants | 0.98 |
Arm 2 Infants | 0.50 |
Arm 3 Infants | 0.55 |
[back to top]
Cumulative Probability of Infant Deaths
The Kaplan-Meier estimate of the cumulative probability of infant deaths from birth through 50 weeks after birth. (NCT03048422)
Timeframe: Birth through 50 weeks after birth
Intervention | Cumulative probability per 100 persons (Number) |
---|
Arm 1 Infants | 1.0 |
Arm 2 Infants | 2.0 |
Arm 3 Infants | 6.9 |
[back to top]
Count of Infants With HIV-1 Antiretroviral Drug Resistance Mutations at the Time of Infant HIV Diagnosis
Count of infants with HIV-1 antiretroviral drug resistance mutations (to any antiretroviral drug) at the time of infant HIV diagnosis, based on laboratory blood test results. (NCT03048422)
Timeframe: From birth through 50 weeks postpartum
Intervention | Participants (Count of Participants) |
---|
Arm 1 Infants | 1 |
Arm 2 Infants | 0 |
Arm 3 Infants | 1 |
[back to top]
Change in Maternal Weight Postpartum
Change in maternal postpartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Delivery to 50 weeks postpartum
Intervention | kg/week (Mean) |
---|
Arm 1: Maternal DTG+FTC/TAF | 0.014 |
Arm 2: Maternal DTG+FTC/TDF | -0.008 |
Arm 3: Maternal EFV/FTC/TDF | -0.032 |
[back to top]
Change in Maternal Weight Antepartum
Change in maternal antepartum weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline through before delivery (up to one day prior)
Intervention | kg/week (Mean) |
---|
Arm 1: Maternal DTG+FTC/TAF | 0.378 |
Arm 2: Maternal DTG+FTC/TDF | 0.319 |
Arm 3: Maternal EFV/FTC/TDF | 0.291 |
[back to top]
Change in Maternal Weight Overall
Change in maternal weight per week based on generalized estimating equations (NCT03048422)
Timeframe: Baseline to 50 weeks postpartum
Intervention | kg/week (Mean) |
---|
Arm 1: Maternal DTG+FTC/TAF | -0.027 |
Arm 2: Maternal DTG+FTC/TDF | -0.050 |
Arm 3: Maternal EFV/FTC/TDF | -0.084 |
[back to top]
Percentage of Mothers With HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery
Percentage of mothers with plasma HIV-1 RNA viral load less than 200 copies/mL at delivery determined using real-time test results obtained at site laboratories. This outcome was evaluated in the non-inferiority (primary outcome) and superiority (secondary outcome) analyses. The intention-to-treat analysis included all randomized women who had viral load data available. The per-protocol analysis excluded women who modified randomized treatment (stopped, paused, switched, added any treatment) before viral load evaluation at delivery, with the exception of women who modified randomized treatment for use of a concomitant medication. (NCT03048422)
Timeframe: Delivery
Intervention | Percentage of participants (Number) |
---|
| Intention-to-Treat Analysis | Per-Protocol Analysis |
---|
Arm 3: Maternal EFV/FTC/TDF | 91.0 | 91.4 |
,Arms 1 and 2: Maternal DTG+FTC/TAF and DTG+FTC/TDF | 97.5 | 97.5 |
[back to top]
Infant Creatinine Clearance
Infant creatinine clearance based on Schwartz formula (NCT03048422)
Timeframe: Delivery and 26 weeks postpartum
Intervention | mL/min (Mean) |
---|
| Delivery | 26 Weeks Postpartum |
---|
Arm 1 Infants | 52.7 | 134.8 |
,Arm 2 Infants | 53.1 | 123.6 |
,Arm 3 Infants | 49.0 | 135.0 |
[back to top]
Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: eGFR
Change in estimated glomerular filtration rate (eGFR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks
Intervention | mL/min/1.73 m^2 (Geometric Mean) |
---|
TDF With a Boosted PI | 86.7 |
TAF With a Boosted PI | 91.0 |
TAF With a Boosted PI and LDV/SOF | 88.1 |
[back to top]
Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs) at 24 and 28 Weeks
Compare tenofovir-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1). (NCT03126370)
Timeframe: 12 weeks, and 24 weeks and 28 weeks
Intervention | fmol/10^6 cells (Geometric Mean) |
---|
TDF With a Boosted PI | 83.0 |
TAF With a Boosted PI | 926 |
TAF With a Boosted PI and LDV/SOF | 1129 |
[back to top]
Change From Week 12 Plasma Tenofovir Area Under the Plasma Concentration vs. Time Curve From Time 0 to 24 Hours (AUC0-24) at 24 and 28 Weeks
Compare plasma tenofovir AUC0-24 between TAF with boosted PI vs. TDF with boosted PI (Phase 2 vs. 1), and between TAF with boosted PI and LDV/SOF vs. TDF with boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 weeks and 28 weeks
Intervention | ng*h/mL (Geometric Mean) |
---|
TDF With a Boosted PI | 3466 |
TAF With a Boosted PI | 743 |
TAF With a Boosted PI and LDV/SOF | 868 |
[back to top]
Change From Week 12 Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS)
Compare tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) between TAF with a boosted PI vs. TDF with a boosted PI (Phase 2 vs. 1), and TAF with a boosted PI and LDV/SOF vs. TDF with a boosted PI (Phase 3 vs. 1) (NCT03126370)
Timeframe: 12 weeks and 24 and 28 weeks
Intervention | fmol/2x7mm punches (Geometric Mean) |
---|
TDF With a Boosted PI | 36014 |
TAF With a Boosted PI | 6735 |
TAF With a Boosted PI and LDV/SOF | 6100 |
[back to top]
Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: B2M/Cr Ratio, and RBP/Cr Ratio
Change in renal biomarkers: urinary beta-2 microglobulin (B2M)/creatinine (Cr) ratio, and urinary retinol binding protein (RBP)/Cr ratio (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks
Intervention | ug/g (Geometric Mean) |
---|
| β2M:Cr ratio | RBP:Cr ratio |
---|
TAF With a Boosted PI | 224 | 242 |
,TAF With a Boosted PI and LDV/SOF | 178 | 146 |
,TDF With a Boosted PI | 419 | 436 |
[back to top]
Change in Estimated Glomerular Filtration Rate (eGFR) and Renal Biomarkers: UPCR
Change in estimated glomerular filtration rate (eGFR) and renal biomarkers: Urine protein to creatinine ratio (UPCR) (NCT03126370)
Timeframe: 12 weeks, 24 weeks, and 28 weeks
Intervention | mg/g (Geometric Mean) |
---|
TDF With a Boosted PI | 134 |
TAF With a Boosted PI | 118 |
TAF With a Boosted PI and LDV/SOF | 97.3 |
[back to top]
Number of Pariicipants With Documented Incident HIV Infections
The number of participants with an incident HIV infection that is confirmed by the HPTN Laboratory Center and Endpoint Adjudication Committee. (NCT03164564)
Timeframe: HIV tests at enrollment, weeks 2, 4, and 5, then every 4 weeks through week 25, then every 8 weeks. Analyzed through week 185 or the date of DSMB decision to unblind all participants, whichever is earliest.
Intervention | Participants (Count of Participants) |
---|
Arm A: CAB + Placebo TDF/FTC + CAB LA | 4 |
Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 36 |
[back to top]
Number of Participants Who Experienced Grade 2 or Higher Clinical and Laboratory Adverse Events (AEs) in Steps 1 and 2
AEs will be summarized using MedDRA System Organ Class and preferred terms. (NCT03164564)
Timeframe: Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks)
Intervention | Participants (Count of Participants) |
---|
Arm A: CAB + Placebo TDF/FTC + CAB LA | 1487 |
Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA | 1486 |
[back to top]
PBMC TFV-DP AUC GMR
The geometric mean ratio (GMR) of the PBMC TFV-DP area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose. (NCT03202511)
Timeframe: The first 72 hours of each phase.
Intervention | fmol*h/10^6cells (Least Squares Mean) |
---|
Treatment Phase | 7.12 |
Control Phase | 7.38 |
[back to top]
Plasma TFV AUC0-INF GMR
The geometric mean ratio (GMR) of the plasma TFV area under the curve (AUC) comparing the test phase (T) to control phase (C) was assessed. PK samples were collected from 0 to 72 hours post-dose. (NCT03202511)
Timeframe: The first 72 hours of each phase.
Intervention | ng*h/mL (Least Squares Mean) |
---|
Treatment Phase | 8.75 |
Control Phase | 8.27 |
[back to top]
Whole Blood Antiretroviral Concentrations
Concentrations will be measured in dried blood spots of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir). Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns. (NCT03218592)
Timeframe: Up to 28 days post-dose
Intervention | fmol / 3mm punch (Median) |
---|
| Phase 1: Single Dose | Phase 2: 7 Doses per Week | Phase 3: 3 Doses Per Week | Phase 3: 1 Dose Per Week | Phase 3: 0 Doses per week |
---|
Dolutegravir | 10 | 718.5 | 60.95 | 10 | 10 |
,Emtricitabine | 50 | 280 | 150.5 | 50 | 50 |
,Maraviroc | 3 | 9.185 | 3 | 3 | 3 |
,Tenofovir | 50 | 809.5 | 811 | 644.5 | 621 |
[back to top]
Plasma Antiretroviral Concentrations
Concentrations will be measured in hair of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir) (NCT03218592)
Timeframe: Up to 28 days post-dose
Intervention | ng/mL (Median) |
---|
| Phase 1: Single dose | Phase2: 7 Doses per Week | Phase 3: 3 Doses Per Week | Phase 3: 1 Dose Per Week | Phase 3: 0 Doses per week |
---|
Dolutegravir | 1 | 1240 | 69.3 | 3.095 | 1 |
,Emtricitabine | 0.5 | 72.3 | 17.2 | 1.2 | 0.5 |
,Maraviroc | 1 | 9.715 | 1.71 | 1 | 1 |
,Tenofovir | 0.5 | 61.9 | 9.4 | 0.5 | 0.5 |
[back to top]
Peripheral Blood Mononuclear Cells (PBMC) Antiretroviral Concentrations
Concentrations of emtricitabine-triphosphate, tenofovir-diphosphate will be measured in peripheral blood mononuclear cells in the Truvada arm only. Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns. (NCT03218592)
Timeframe: Up to 28 days post-dose
Intervention | fmol/10^6 cells (Median) |
---|
| Phase 1 Single Dose | Phase 2: 7 Doses per Week | Phase 3: 3 Doses Per Week | Phase 3: 1 Dose Per Week | Phase 3: Zero Doses per week |
---|
Emtricitabine (Truvada) | 27.09 | 4460 | 2388.69 | 267.82 | 27.48 |
,Tenfovir (Truvada) | 2.1 | 127.1 | 60 | 15.7 | 10.4 |
[back to top]
Hair Antiretroviral Imaging
Signal Strength concentrations will be measured in hair for all study drugs, inclusive of FTC (emtricitabine), tenofovir (TFV), maraviroc (MRV), and dolutegravir (DTG) using Matrix-assisted Laser Desorption Electrospray Ionization (IR-MALDESI) to be reported by signal abundance (au). Signal abundance is the industry standard unit, and higher values represent greater signal with capability to relate to comparative concentrations. (NCT03218592)
Timeframe: Up to 28 days post dose
Intervention | Signal Abundance (au) (Median) |
---|
| Phase 3: Zero Doses Per Week | Phase 3: 1 Dose Per week | Phase 3: 3 Doses Per Week | Phase 2: Daily Dosing | Phase 1: Single Dose |
---|
Dolutegravir | 1092.130868 | 2377.868226 | 5504.883169 | 14251.46653 | NA |
,Maraviroc | 156.4826656 | 3942.692396 | 27814.98823 | 46013.29104 | NA |
,Truvada | 0.501209 | 156.1127125 | 466.7986895 | 824.721385 | NA |
[back to top]
DOT Diary Mobile App Ease of Use
5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) on a single question of the key attribute of ease of use of DOT Diary over 8 weeks by MSM on PrEP. (NCT03387462)
Timeframe: 8 weeks
Intervention | Score on a scale (Likert) (Median) |
---|
DOT Diary Optimization Intervention | 4 |
[back to top]
Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP
Adherence and Persistence of use of the DOT and sexual diary components of DOT Diary by young MSM on PrEP is measured by the percentage of doses taken with visual confirmation of pill ingestion (NCT03387462)
Timeframe: 8 weeks
Intervention | Percentage of doses taken (Number) |
---|
DOT Diary Optimization Intervention | 93 |
[back to top]
DOT Diary Mobile App Acceptability
System Usability Scale (SUS) is a 10 item questionnaire with 5 response options: strongly disagree to strongly agree. These are scored 0-4. The scores are then summed up (making sure all positive responses -- increased usability -- are given the higher scores). The final score is multiplied by 2.5 Possible scores are from 0-100, with maximal usability achieving the higher score. Although the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. (NCT03387462)
Timeframe: 8 weeks
Intervention | Score on scale (Mean) |
---|
DOT Diary Optimization Intervention | 79.8 |
[back to top]
Assessment of Situations and Reasons for Sub-optimal Use of the App
Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization (NCT03387462)
Timeframe: 8 weeks
Intervention | Count of participants for each reason (Number) |
---|
| Technical problems | Away from home |
---|
DOT Diary Optimization Intervention | 8 | 6 |
[back to top]
Number of Patients Offered Rapid HIV Treatment Initiation
(NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
[back to top]
Number of Patients Who Accepted Rapid HIV Treatment Initiation
(NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
[back to top]
Rapid HIV Treatment Initiation Acceptability as Assessed by the Number of Patients Who Respond Yes to Starting ART Same Day
Number of patients who respond yes to starting ART same day versus those who respond no in the survey. (NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
[back to top]
Number of Patients Who Receive Rapid HIV Treatment Initiation
Number of patients who do start Anti-retroviral Therapy (ART) the same day it is offered. (NCT03512964)
Timeframe: 12 months
Intervention | Participants (Count of Participants) |
---|
Rapid HIV Treatment Initiation | 32 |
[back to top]
Number of Participant-Visits With No Product Use
"During the study period where participants were randomized to use FTC/TDF they were assessed for FTC/TDF adherence by dried blood spot (DBS) at monthly visits. Results that were below the lower limit of detection (< 16.6 fmol/punch) were classified as no use of FTC/TDF during the preceding month, and detectable results (>= 16.6 fmol/punch) classified as at least some FTC/TDF use.~During the study period where participants were randomized to use the dapivirine vaginal ring (VR) they were assessed for ring adherence by residual drug levels in returned VRs. Results that were less than or equal to a rate of 0.9mg dapivirine released per month were classified as no use of the VR during that month, and results greater than 0.9mg dapivirine release per month classified as at least some VR use." (NCT03593655)
Timeframe: Study periods 1 and 2
Intervention | Visits (Count of Units) |
---|
| Study Period 171925903 | Study Period 171925904 | Study Period 271925904 | Study Period 271925903 |
---|
| No use | At least some use |
---|
Dapivirine Vaginal Ring | 19 |
FTC/TDF | 11 |
Dapivirine Vaginal Ring | 705 |
FTC/TDF | 660 |
Dapivirine Vaginal Ring | 41 |
FTC/TDF | 10 |
Dapivirine Vaginal Ring | 642 |
FTC/TDF | 635 |
[back to top]
Number of Participant-Visits Reporting Acceptability of Study Product
"During the study period where participants were randomized to use FTC/TDF they were asked to rate how much they liked using the tablets for HIV prevention (3 and 6 months after initiating the product).~During the study period where participants were randomized to use the dapivirine vaginal ring they were asked to rate how much they liked using the ring for HIV prevention (3 and 6 months after initiating the product)." (NCT03593655)
Timeframe: Study periods 1 and 2
Intervention | Visits (Count of Units) |
---|
| Week 1271925903 | Week 1271925904 | Week 2471925903 | Week 2471925904 | Week 3671925903 | Week 3671925904 | Week 4871925904 | Week 4871925903 |
---|
| Neither like nor dislike, dislike, or dislike very | Like, or like very much |
---|
FTC/TDF | 72 |
Dapivirine Vaginal Ring | 5 |
FTC/TDF | 35 |
Dapivirine Vaginal Ring | 105 |
FTC/TDF | 73 |
Dapivirine Vaginal Ring | 6 |
FTC/TDF | 32 |
Dapivirine Vaginal Ring | 91 |
FTC/TDF | 93 |
Dapivirine Vaginal Ring | 14 |
FTC/TDF | 18 |
Dapivirine Vaginal Ring | 90 |
FTC/TDF | 68 |
Dapivirine Vaginal Ring | 21 |
FTC/TDF | 47 |
[back to top]
Number of Participants With Grade 2 or Higher Adverse Events (AEs)
"During participants' first year on study (i.e., during first and second product use periods) participants were randomized to use either the dapivirine vaginal ring for 6 months followed by FTC/TDF for 6 months or vice versa. All AEs were reported as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. AEs that were graded as at least Grade 2 (i.e., moderate or higher) were classified into the two periods based on reported date of AE onset, with AEs occurring between the participant's randomization date and the date 30 days after their Week 24 visit classified into Period 1, and AEs occurring between their Week 24 visit and the date 30 days after their Week 48 visit classified into Period 2. AEs occurring within 30 days of the Week 24 visit were counted in both periods.~This is the number of participant-periods with at least one grade 2 or higher AE by product (combining the two product use periods)." (NCT03593655)
Timeframe: Study periods 1 and 2
Intervention | Participants (Count of Participants) |
---|
| Study Period 1 (Weeks 1-24)71925903 | Study Period 1 (Weeks 1-24)71925904 | Study Period 2 (Weeks 25-48)71925903 | Study Period 2 (Weeks 25-48)71925904 |
---|
| No grade 2+ AE | At least one grade 2+ AE |
---|
Dapivirine Vaginal Ring | 36 |
FTC/TDF | 36 |
Dapivirine Vaginal Ring | 88 |
FTC/TDF | 87 |
Dapivirine Vaginal Ring | 22 |
FTC/TDF | 28 |
Dapivirine Vaginal Ring | 95 |
FTC/TDF | 94 |
[back to top]
Percentage of Participants Reporting Preference for Dapivirine VR as Compared to FTC/TDF Oral Tablets
"Participants were asked would you prefer to use the ring or the tablets for HIV prevention? at their enrollment, Month 12, and product use end visit (Month 18) visits." (NCT03593655)
Timeframe: All three study periods (enrollment, month 12, and month 18 study visits)
Intervention | Participants (Count of Participants) |
---|
| Enrollment71925906 | Enrollment71925905 | Month 1271925905 | Month 1271925906 | Month 1871925905 | Month 1871925906 |
---|
| Neither product | Skipped question | Preferred ring | Preferred tablets | Either product equally |
---|
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 51 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 43 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 43 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 57 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 29 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 18 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 0 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 1 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 74 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 76 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 37 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 30 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 5 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 2 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 1 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 67 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 66 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 35 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 33 |
Sequence A: Dapivirine Vaginal Ring + FTC/TDF | 13 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 5 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 4 |
Sequence B: FTC/TDF + Dapivirine Vaginal Ring | 0 |
[back to top]
Change in Serum Biomarkers of Inflammation (Hs-CRP (in mg/L))
"Change in serum biomarkers of inflammation (hs-CRP (in mg/L)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of inflammation (high sensitivity C-reactive protein) were measured. hs-CRP > 1 mg/L are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks
Intervention | mg/L (Mean) |
---|
HIV Patients on Stable Therapy | -0.40 |
[back to top]
Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL))
"Change in Myocyte Injury and Strain (NT-proBNP (in pg/mL)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of myocardial injury/strain (NT-pro-BNP) were measured. NT-proBNP > 100 pg/mL are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks
Intervention | pg/mL (Mean) |
---|
HIV Patients on Stable Therapy | -14.2 |
[back to top]
Change in Myocyte Injury and Strain (hs Troponin (in ng/L))
"Change in Myocyte Injury and Strain (hs Troponin (in ng/L)) at 24 weeks after initiation of B/F/TAF.~Serum biomarkers of myocardial injury/strain (high sensitivity troponin) were measured. hs-troponin >14 ng/L are considered abnormal and associated with increased cardiovascular risk." (NCT03656783)
Timeframe: Baseline and 24 weeks
Intervention | ng/L (Mean) |
---|
HIV Patients on Stable Therapy | -0.04 |
[back to top]
Change in Global CFR
"Change in global coronary flow reserve, as measured by PET imaging at baseline and 24 weeks after initiation of B/F/TAF therapy.~Coronary flow reserve (CFR), the ratio of peak vasodilator stress to rest myocardial blood flow (MBF), represents the maximal ability to augment coronary flow and myocardial perfusion. Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired MBFR is defined as a ratio of <2.0, which is associated with increased cardiovascular risk." (NCT03656783)
Timeframe: baseline and week 24
Intervention | ratio (Mean) |
---|
HIV Patients on Stable Therapy | -.05 |
[back to top]
Change in Peak Stress Global MBF
"Change (from baseline) in peak-stress global myocardial blood flow (in mL/min/g) at 24 weeks after initiation of B/F/TAF.~Absolute MBF was computed from the rest and stress myocardial perfusion PET images using commercially available software (Corridor4DM; Ann Arbor, Michigan) and a two-compartment tracer kinetic model. Impaired stress MBF is defined as <1.8 mL/min/g and is associated with increased cardiovascular risk." (NCT03656783)
Timeframe: baseline and 24 weeks
Intervention | mL/min/g (Mean) |
---|
HIV Patients on Stable Therapy | 0.09 |
[back to top]
FTC Cmax
Maximum Plasma Concentration (Cmax) for Emtricitabine (ng/mL) (NCT03717129)
Timeframe: 72 hr
Intervention | ng/mL (Mean) |
---|
Genvoya Oral Dose | 2095 |
Genvoya Crushed Dose | 1968 |
[back to top]
EVG Half-life
Terminal elimination half-life for EVG (hours). (NCT03717129)
Timeframe: 72 hours
Intervention | hours (Mean) |
---|
Genvoya Oral Dose | 5 |
Genvoya Crushed Dose | 5.1 |
[back to top]
AUC0-∞ for Tenofovir (TFV)
AUC 0 to Infinity for TFV (ng*h/mL) (NCT03717129)
Timeframe: 72 hours
Intervention | ng*h/mL (Mean) |
---|
Genvoya Oral Dose | 253 |
Genvoya Crushed Dose | 241 |
[back to top]
AUC0-∞ for FTC
AUC 0 to Infinity for Emtricitabine (ng*h/mL) (NCT03717129)
Timeframe: 72 hours
Intervention | ng*h/mL (Mean) |
---|
Genvoya Oral Dose | 11603 |
Genvoya Crushed Dose | 10969 |
[back to top]
Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG
AUC 0 to Infinity for Elvitegravir (ng*h/mL) (NCT03717129)
Timeframe: 72 hours
Intervention | ng*h/mL (Mean) |
---|
Genvoya Oral Dose | 24219 |
Genvoya Crushed Dose | 26948 |
[back to top]
FTC Half-life
Terminal elimination half-life for FTC (hours). (NCT03717129)
Timeframe: 72 hours
Intervention | hours (Mean) |
---|
Genvoya Oral Dose | 15.2 |
Genvoya Crushed Dose | 16.1 |
[back to top]
TFV Half-life
Terminal elimination half-life for TFV (hours). (NCT03717129)
Timeframe: 72 hours
Intervention | hours (Mean) |
---|
Genvoya Oral Dose | 42.5 |
Genvoya Crushed Dose | 40.7 |
[back to top]
TFV Cmax
Maximum Plasma Concentration (Cmax) for Tenofovir (ng/mL) (NCT03717129)
Timeframe: 72 hr
Intervention | ng/mL (Mean) |
---|
Genvoya Oral Dose | 11 |
Genvoya Crushed Dose | 9.5 |
[back to top]
EVG Cmax
Maximum Plasma Concentration (Cmax) for Elvitegravir (ng/mL) (NCT03717129)
Timeframe: 72 Hr
Intervention | ng/mL (Mean) |
---|
Genvoya Oral Dose | 1650 |
Genvoya Crushed Dose | 1946 |
[back to top]
HBV DNA at Week 48
Proportion of participants with plasma HBV DNA <29 IU/mL at Week 48 as defined by Missing=Failure Approach (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 22 |
[back to top]
CD4 Cell Count Change at Week 48
Change from baseline in CD4 cell count at Week 48 (NCT03797014)
Timeframe: Baseline; Week 48
Intervention | cells/microliter (Mean) |
---|
B/F/TAF | 76.6 |
[back to top]
HBeAg Loss at Week 48
Proportion of participants with hepatitis B envelop antigen (HBeAg) loss at Week 48 visit. (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 0 |
[back to top]
HIV-1 RNA at Week 24
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 24 by US FDA Snapshot Algorithm (NCT03797014)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 25 |
[back to top]
HBsAg Loss at Week 48
Proportion of participants with hepatitis B surface antigen (HBsAg) loss at Week 48 visit. (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 0 |
[back to top]
CD4 Cell Count Change at Week 24
Change from baseline in CD4 cell count at Week 24 (NCT03797014)
Timeframe: Baseline; Week 24
Intervention | cells/microliter (Mean) |
---|
B/F/TAF | 32.8 |
[back to top]
HIV-1 RNA at Week 48
Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 by US FDA Snapshot Algorithm (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 22 |
[back to top]
ALT Normalization at Week 24
Proportion of participants with normal ALT at Week 24 (NCT03797014)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 4 |
[back to top]
ALT Normalization at Week 48
Proportion of participants with normal ALT at Week 48 (NCT03797014)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 4 |
[back to top]
HBV DNA at Week 24
Proportion of participants with plasma HBV DNA <29 IU/mL at Week 24 as defined by Missing=Failure Approach (NCT03797014)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 24 |
[back to top]
Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Day 3, n= 16 | Alkaline phosphatase, Day 7, n= 15 | Alkaline phosphatase, Day 9, n= 15 | AST, Day 3, n= 16 | AST, Day 7, n= 15 | AST, Day 9, n= 15 | ALT, Day 3, n= 16 | ALT, Day 7, n= 15 | ALT, Day 9, n= 15 | GGT, Day 3, n= 16 | GGT, Day 7, n= 15 | GGT, Day 9, n= 15 | LDH, Day 3, n= 16 | LDH, Day 7, n= 15 | LDH, Day 9, n= 15 | CK, Day 3, n= 16 | CK, Day 7, n= 15 | CK, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 3.7 | 2.6 | -1.0 | -1.4 | -0.5 | -0.1 | -2.0 | -1.9 | -0.7 | -0.9 | -1.4 | -1.9 | -7.0 | -8.2 | -7.0 | 3.4 | 11.3 | -2.3 |
[back to top]
Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Day 3, n= 15 | Glucose, Day 7, n= 15 | Glucose, Day 9, n= 15 | Cholesterol, Day 3, n=15 | Cholesterol, Day 7, n= 15 | Cholesterol, Day 9, n= 16 | Anion gap, Day 3, n= 16 | Anion gap, Day 7, n= 15 | Anion gap, Day 9, n= 15 | Calcium, Day 3, n= 16 | Calcium, Day 7, n= 15 | Calcium, Day 9, n= 15 | CO2, Day 3, n= 16 | CO2, Day 7, n= 15 | CO2, Day 9, n= 15 | Chloride, Day 3, n= 16 | Chloride, Day 7, n= 15 | Chloride, Day 9, n= 15 | Phosphate, Day 3, n= 16 | Phosphate, Day 7, n= 15 | Phosphate, Day 9, n= 15 | Potassium, Day 3, n= 16 | Potassium, Day 7, n= 15 | Potassium, Day 9, n= 15 | Sodium, Day 3, n= 16 | Sodium, Day 7, n= 15 | Sodium, Day 9, n= 15 | Triglycerides, Day 3, n= 16 | Triglycerides, Day 7, n= 15 | Triglycerides, Day 9, n= 15 | BUN, Day 3, n= 16 | BUN, Day 7, n= 15 | BUN, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.236 | 0.315 | 0.136 | 0.011 | 0.102 | 0.030 | -0.4 | -0.5 | -0.3 | 0.013 | 0.037 | 0.033 | -0.5 | -0.1 | -0.4 | 2.3 | 0.6 | 1.3 | 0.062 | 0.002 | 0.007 | 0.01 | -0.03 | 0.10 | 1.4 | 0.1 | 0.6 | -0.003 | 0.111 | -0.049 | 0.312 | -0.031 | -0.028 |
[back to top]
Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Units per Liter (Mean) |
---|
| Amylase, Day 3, n= 16 | Amylase, Day 7, n= 15 | Amylase, Day 9, n= 15 | Lipase, Day 3, n= 16 | Lipase, Day 7, n= 15 | Lipase, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 3.3 | -1.9 | 1.1 | 7.7 | 0.0 | 3.5 |
[back to top]
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Day 3, n= 16 | Creatinine, Day 7, n= 15 | Creatinine, Day 9, n= 15 | Total bilirubin, Day 3, n= 16 | Total bilirubin, Day 7, n= 15 | Total bilirubin, Day 9, n= 15 | Direct bilirubin, Day 3, n= 16 | Direct bilirubin, Day 7, n= 15 | Direct bilirubin, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -2.34 | 3.53 | 0.28 | -0.82 | -0.26 | -1.91 | -0.26 | -0.03 | -0.49 |
[back to top]
Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Day 3, n= 16 | Total Protein, Day 7, n= 15 | Total Protein, Day 9, n= 15 | Globulin, Day 3, n= 16 | Globulin, Day 7, n= 15 | Globulin, Day 9, n= 15 | Albumin, Day 3, n= 16 | Albumin, Day 7, n= 15 | Albumin, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.1 | 3.1 | 0.8 | 0.2 | 2.3 | 0.2 | -0.1 | 0.9 | 0.6 |
[back to top]
Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Milliseconds (Mean) |
---|
| PR Interval, Day 1, 2 hours post-dose, n= 16 | PR Interval, Day 1, 4 hours post-dose, n= 16 | PR Interval, Day 4, Pre-dose, n= 15 | PR Interval, Day 4, 2 hours post-dose, n= 15 | PR Interval, Day 4, 4 hours post-dose, n= 15 | PR Interval, Day 7, Pre-dose, n= 15 | PR Interval, Day 7, 2 hours post-dose, n= 15 | PR Interval, Day 7, 4 hours post-dose, n= 15 | PR Interval, Day 9 post-dose, n= 15 | QRS Duration, Day 1, 2 hours post-dose, n= 16 | QRS Duration, Day 1, 4 hours post-dose, n= 16 | QRS Duration, Day 4, Pre-dose, n= 15 | QRS Duration, Day 4, 2 hours post-dose, n= 15 | QRS Duration, Day 4, 4 hours post-dose, n= 15 | QRS Duration, Day 7, Pre-dose, n= 15 | QRS Duration, Day 7, 2 hours post-dose, n= 15 | QRS Duration, Day 7, 4 hours post-dose, n= 15 | QRS Duration, Day 9 post-dose, n= 15 | QT Interval, Day 1, 2 hours post-dose, n= 16 | QT Interval, Day 1, 4 hours post-dose, n= 16 | QT Interval, Day 4, Pre-dose, n= 15 | QT Interval, Day 4, 2 hours post-dose, n= 15 | QT Interval, Day 4, 4 hours post-dose, n= 15 | QT Interval, Day 7, Pre-dose, n= 15 | QT Interval, Day 7, 2 hours post-dose, n= 15 | QT Interval, Day 7, 4 hours post-dose, n= 15 | QT Interval, Day 9 post-dose, n= 15 | QTcF Interval, Day 1, 2 hours post-dose, n= 16 | QTcF Interval, Day 1, 4 hours post-dose, n= 16 | QTcF Interval, Day 4, Pre-dose, n= 15 | QTcF Interval, Day 4, 2 hours post-dose, n= 15 | QTcF Interval, Day 4, 4 hours post-dose, n= 15 | QTcF Interval, Day 7, Pre-dose, n= 15 | QTcF Interval, Day 7, 2 hours post-dose, n= 15 | QTcF Interval, Day 7, 4 hours post-dose, n= 15 | QTcF Interval, Day 9 post-dose, n= 15 | QTcB Interval, Day 1, 2 hours post-dose, n= 16 | QTcB Interval, Day 1, 4 hours post-dose, n= 16 | QTcB Interval, Day 4, Pre-dose, n= 15 | QTcB Interval, Day 4, 2 hours post-dose, n= 15 | QTcB Interval, Day 4, 4 hours post-dose, n= 15 | QTcB Interval, Day 7, Pre-dose, n= 15 | QTcB Interval, Day 7, 2 hours post-dose, n= 15 | QTcB Interval, Day 7, 4 hours post-dose, n= 15 | QTcB Interval, Day 9 post-dose, n= 15 |
---|
TAF/FTC+GSK3640254 | -6.8 | -3.7 | -0.5 | -6.9 | -3.9 | -2.7 | -3.3 | -3.7 | 1.2 | -2.5 | -1.4 | 0.5 | 0.5 | -0.2 | 3.3 | 1.5 | 0.3 | 3.0 | -12.6 | -1.8 | 7.3 | -6.8 | 5.6 | 3.5 | -8.4 | 5.8 | 4.1 | -4.4 | 2.4 | 6.1 | -0.6 | 4.5 | 4.1 | -5.1 | 0.6 | 7.9 | 0.7 | 4.7 | 5.5 | 2.5 | 4.3 | 4.6 | -3.2 | -1.7 | 10.3 |
[back to top]
Period 2: Change From Baseline in Heart Rate
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Beats per minute (Mean) |
---|
| Day 1, 2 hours post-dose, n= 16 | Day 1, 4 hours post-dose, n= 16 | Day 4, Pre-dose, n= 15 | Day 4, 2 hours post-dose, n= 15 | Day 4, 4 hours post-dose, n= 15 | Day 7, Pre-dose, n= 15 | Day 7, 2 hours post-dose, n= 15 | Day 7, 4 hours post-dose, n= 15 | Day 9 post-dose, n= 15 |
---|
TAF/FTC+GSK3640254 | 5.0 | 2.8 | -0.5 | 3.3 | -0.3 | 0.3 | 1.8 | -2.3 | 2.1 |
[back to top]
Period 2: Change From Baseline in Hematology Parameter of Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Trillion cells per liter (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.113 | 0.000 | -0.189 |
[back to top]
Period 2: Change From Baseline in Hematology Parameter of Hematocrit
Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.0147 | -0.0007 | -0.0204 |
[back to top]
Period 2: Change From Baseline in Hematology Parameter of Hemoglobin
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per liter (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -3.9 | -1.1 | -6.4 |
[back to top]
Period 2: Change From Baseline in Hematology Parameter of MCH
Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Picograms (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.11 | -0.21 | -0.17 |
[back to top]
Period 2: Change From Baseline in Hematology Parameter of MCV
Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Femtoliters (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -1.02 | -0.17 | -0.82 |
[back to top]
Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 2 Day 3, n= 15 | Basophils, Period 2 Day 7, n= 15 | Basophils, Period 2 Day 9, n= 15 | Eosinophils, Period 2 Day 3, n=15 | Eosinophils, Period 2 Day 7, n=15 | Eosinophils, Period 2 Day 9, n=16 | Monocytes, Period 2 Day 3, n= 16 | Monocytes, Period 2 Day 7, n= 15 | Monocytes, Period 2 Day 9, n= 15 | Leukocytes, Period 2 Day 3, n= 16 | Leukocytes, Period 2 Day 7, n= 15 | Leukocytes, Period 2 Day 9, n= 15 | Lymphocytes, Period 2 Day 3, n= 16 | Lymphocytes, Period 2 Day 7, n= 15 | Lymphocytes, Period 2 Day 9, n= 15 | Neutrophils, Period 2 Day 3, n= 16 | Neutrophils, Period 2 Day 7, n= 15 | Neutrophils, Period 2 Day 9, n= 15 | Platelets, Period 2 Day 3, n= 16 | Platelets, Period 2 Day 7, n= 15 | Platelets, Period 2 Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | -0.004 | -0.002 | 0.003 | -0.023 | -0.039 | -0.043 | -0.053 | -0.077 | -0.104 | -1.06 | -0.61 | -0.49 | -0.158 | -0.105 | -0.111 | -0.868 | -0.417 | -0.282 | 9.2 | 19.8 | 16.2 |
[back to top]
Period 2: Change From Baseline in pH of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | pH (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.19 | 0.10 | 0.10 |
[back to top]
Period 2: Change From Baseline in Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Beats per minute (Mean) |
---|
| Day 4 | Day 7 | Day 9 | Day 10 |
---|
TAF/FTC+GSK3640254 | 2.4 | 1.9 | -0.3 | 9.5 |
[back to top]
Period 2: Change From Baseline in Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Breaths per minute (Mean) |
---|
| Day 4 | Day 7 | Day 9 | Day 10 |
---|
TAF/FTC+GSK3640254 | -3.2 | -2.4 | -0.8 | -1.5 |
[back to top]
Period 2: Change From Baseline in Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Ratio (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.0031 | 0.0024 | 0.0005 |
[back to top]
Period 2: Change From Baseline in Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Degree Celsius (Mean) |
---|
| Day 4 | Day 7 | Day 9 | Day 10 |
---|
TAF/FTC+GSK3640254 | -0.10 | -0.07 | -0.01 | 0.07 |
[back to top]
Period 2: Change From Baseline in Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.0000 | 0.0000 | 0.0000 |
[back to top]
Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Units per Liter (Mean) |
---|
| Amylase, Baseline | Amylase, Day 7 | Amylase, Day 14 | Lipase, Baseline | Lipase, Day 7 | Lipase, Day 14 |
---|
TAF/FTC | 56.4 | 54.1 | 53.6 | 22.2 | 18.2 | 16.9 |
[back to top]
Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Baseline | Alkaline phosphatase, Day 7 | Alkaline phosphatase, Day 14 | AST, Baseline | AST, Day 7 | AST, Day 14 | ALT, Baseline | ALT, Day 7 | ALT, Day 14 | GGT Baseline | GGT Day 7 | GGT Day 14 | LDH, Baseline | LDH, Day 7 | LDH, Day 9 | CK, Baseline | CK, Day 7 | CK, Day 14 |
---|
TAF/FTC | 60.9 | 58.3 | 63.4 | 24.6 | 18.4 | 17.6 | 26.6 | 24.4 | 20.4 | 1.76 | 1.91 | 2.40 | 138.0 | 123.4 | 126.0 | 219.6 | 116.6 | 120.4 |
[back to top]
Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Baseline | Glucose, Day 7 | Glucose, Day 14 | Cholesterol, Baseline | Cholesterol, Day 7 | Cholesterol, Day 14 | Anion gap, Baseline | Anion gap, Day 7 | Anion gap, Day 14 | Calcium, Baseline | Calcium, Day 7 | Calcium, Day 14 | CO2, Baseline | CO2, Day 7 | CO2, Day 14 | Chloride, Baseline | Chloride, Day 7 | Chloride, Day 14 | Phosphate, Baseline | Phosphate, Day 7 | Phosphate, Day 14 | Potassium, Baseline | Potassium, Day 7 | Potassium, Day 14 | Sodium, Baseline | Sodium, Day 7 | Sodium, Day 14 | Triglycerides, Baseline | Triglycerides, Day 7 | Triglycerides, Day 14 | BUN, Baseline | BUN, Day 7 | BUN, Day 14 |
---|
TAF/FTC | 5.111 | 4.951 | 4.791 | 4.253 | 4.249 | 3.864 | 8.7 | 10.6 | 10.9 | 2.359 | 2.387 | 2.387 | 31.7 | 30.1 | 30.8 | 103.3 | 102.2 | 101.3 | 1.078 | 1.094 | 1.103 | 4.25 | 4.28 | 4.22 | 139.4 | 138.8 | 138.8 | 1.076 | 1.168 | 1.033 | 4.441 | 4.423 | 4.246 |
[back to top]
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Baseline | Creatinine, Day 7 | Creatinine, Day 14 | Total bilirubin, Baseline | Total bilirubin, Day 7 | Total bilirubin, Day 14 | Direct bilirubin, Baseline | Direct bilirubin, Day 7 | Direct bilirubin, Day 14 |
---|
TAF/FTC | 80.16 | 85.85 | 87.52 | 9.64 | 11.89 | 11.74 | 1.76 | 1.91 | 2.40 |
[back to top]
Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Baseline | Total Protein, Day 7 | Total Protein, Day 14 | Globulin, Baseline | Globulin, Day 7 | Globulin, Day 14 | Albumin, Baseline | Albumin, Day 7 | Albumin, Day 14 |
---|
TAF/FTC | 69.8 | 72.4 | 72.6 | 25.9 | 28.4 | 28.7 | 43.9 | 44.0 | 43.9 |
[back to top]
Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose
Intervention | Milliseconds (Mean) |
---|
| PR Interval, Baseline | PR Interval, Day 1, 2 hours post-dose | PR Interval, Day 1, 4 hours post-dose | QRS Duration, Baseline | QRS Duration, Day 1, 2 hours post-dose | QRS Duration, Day 1, 4 hours post-dose | QT Interval, Baseline | QT Interval, Day 1, 2 hours post-dose | QT Interval, Day 1, 4 hours post-dose | QTcF Interval, Baseline | QTcF Interval, Day 1, 2 hours post-dose | QTcF Interval, Day 1, 4 hours post-dose | QTcB Interval, Baseline | QTcB Interval, Day 1, 2 hours post-dose | QTcB Interval, Day 1, 4 hours post-dose |
---|
TAF/FTC | 161.3 | 162.8 | 159.4 | 91.0 | 89.9 | 91.3 | 377.8 | 370.3 | 383.6 | 391.6 | 386.7 | 390.3 | 398.8 | 394.6 | 393.3 |
[back to top]
Period 1: Absolute Values of Heart Rate
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose
Intervention | Beats per minute (Mean) |
---|
| Baseline | Day 1, 2 hours post-dose | Day 1, 4 hours post-dose |
---|
TAF/FTC | 67.6 | 69.1 | 64.4 |
[back to top]
Period 1: Absolute Values of Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Beats per minute (Mean) |
---|
| Baseline | Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | 73.9 | 72.8 | 70.1 | 69.9 | 72.3 | 66.3 |
[back to top]
Period 1: Absolute Values of Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Ratio (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 1.0136 | 1.0143 | 1.0147 |
[back to top]
Period 1: Absolute Values of Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Degree Celsius (Mean) |
---|
| Baseline | Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | 36.49 | 36.33 | 36.34 | 36.41 | 36.34 | 36.25 |
[back to top]
Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 1 Baseline | Basophils, Period 1 Day 7 | Basophils, Period 1 Day 14 | Eosinophils, Period 1 Baseline | Eosinophils, Period 1 Day 7 | Eosinophils, Period 1 Day 14 | Monocytes, Period 1 Baseline | Monocytes, Period 1 Day 7 | Monocytes, Period 1 Day 14 | Leukocytes, Period 1 Baseline | Leukocytes, Period 1 Day 7 | Leukocytes, Period 1 Day 14 | Lymphocytes, Period 1 Baseline | Lymphocytes, Period 1 Day 7 | Lymphocytes, Period 1 Day 14 | Neutrophils, Period 1 Baseline | Neutrophils, Period 1 Day 7 | Neutrophils, Period 1 Day 14 | Platelets, Period 1 Baseline | Platelets, Period 1 Day 7 | Platelets, Period 1 Day 14 |
---|
TAF/FTC | 0.046 | 0.041 | 0.040 | 0.225 | 0.204 | 0.205 | 0.522 | 0.536 | 0.571 | 6.18 | 6.10 | 6.45 | 1.945 | 1.699 | 1.683 | 3.441 | 3.628 | 3.954 | 253.3 | 256.6 | 275.1 |
[back to top]
Period 1: Absolute Values of the Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Trillion cells per liter (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 4.977 | 5.166 | 5.203 |
[back to top]
Period 1: Absolute Values of the Hematology Parameter: Hematocrit
Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 0.4264 | 0.4384 | 0.4453 |
[back to top]
Period 1: Absolute Values of the Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per liter (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 142.0 | 148.1 | 150.4 |
[back to top]
Period 1: Absolute Values of the Hematology Parameter: MCH
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Picograms (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 28.63 | 28.75 | 28.98 |
[back to top]
Period 1: Absolute Values of the Hematology Parameter: MCV
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Femtoliters (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 85.92 | 85.09 | 85.85 |
[back to top]
Period 1: Absolute Values of Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 5.9255 | 3.3860 | 3.3860 |
[back to top]
Period 1: Change From Baseline in Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Day 2 | SBP, Day 3 | SBP, Day 4 | SBP, Day 5 | SBP, Day 7 | DBP, Day 2 | DBP, Day 3 | DBP, Day 4 | DBP, Day 5 | DBP, Day 7 |
---|
TAF/FTC | 1.4 | -1.8 | -2.7 | -2.3 | 0.8 | 0.1 | -1.6 | 0.1 | -1.4 | 2.9 |
[back to top]
Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Day 7 | Alkaline phosphatase, Day 14 | AST, Day 7 | AST, Day 14 | ALT, Day 7 | ALT, Day 14 | GGT Day 7 | GGT Day 14 | LDH, Day 7 | LDH, Day 14 | CK, Day 7 | CK, Day 14 |
---|
TAF/FTC | -2.6 | 2.4 | -6.2 | -6.9 | -2.1 | -6.2 | 0.2 | -1.7 | -14.6 | -12.0 | -103.0 | -99.2 |
[back to top]
Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Day 7 | Glucose, Day 14 | Cholesterol, Day 7 | Cholesterol, Day 14 | Anion gap, Day 7 | Anion gap, Day 14 | Calcium, Day 7 | Calcium, Day 14 | CO2, Day 7 | CO2, Day 14 | Chloride, Day 7 | Chloride, Day 14 | Phosphate, Day 7 | Phosphate, Day 14 | Potassium, Day 7 | Potassium, Day 14 | Sodium, Day 7 | Sodium, Day 14 | Triglycerides, Day 7 | Triglycerides, Day 14 | BUN, Day 7 | BUN, Day 14 |
---|
TAF/FTC | -0.160 | -0.320 | -0.004 | -0.389 | 1.9 | 2.2 | 0.028 | 0.028 | -1.6 | -0.9 | -1.1 | -2.0 | 0.017 | 0.026 | 0.03 | -0.03 | -0.6 | -0.6 | 0.092 | -0.044 | -0.018 | -0.195 |
[back to top]
Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Units per Liter (Mean) |
---|
| Amylase, Day 7 | Amylase, Day 14 | Lipase, Day 7 | Lipase, Day 14 |
---|
TAF/FTC | -2.3 | -2.8 | -4.0 | -5.3 |
[back to top]
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Day 7 | Creatinine, Day 14 | Total bilirubin, Day 7 | Total bilirubin, Day 14 | Direct bilirubin, Day 7 | Direct bilirubin, Day 14 |
---|
TAF/FTC | 5.69 | 7.36 | 2.25 | 2.10 | 0.15 | 0.64 |
[back to top]
Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Day 7 | Total Protein, Day 14 | Globulin, Day 7 | Globulin, Day 14 | Albumin, Day 7 | Albumin, Day 14 |
---|
TAF/FTC | 2.6 | 2.9 | 2.5 | 2.8 | 0.1 | 0.1 |
[back to top]
[back to top]
Period 1: Change From Baseline in Heart Rate
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose
Intervention | Beats per minute (Mean) |
---|
| Day 1, 2 hours post-dose | Day 1, 4 hours post-dose |
---|
TAF/FTC | 1.5 | -3.3 |
[back to top]
Period 1: Change From Baseline in Hematology Parameter of Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Trillion cells per liter (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.189 | 0.226 |
[back to top]
Period 1: Change From Baseline in Hematology Parameter of Hematocrit
Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.0121 | 0.0189 |
[back to top]
Period 1: Change From Baseline in Hematology Parameter of Hemoglobin
Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Grams per liter (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 6.1 | 8.4 |
[back to top]
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Femtoliters (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | -0.83 | -0.07 |
[back to top]
Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, and 14
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 1 Day 7 | Basophils, Period 1 Day 14 | Eosinophils, Period 1 Day 7 | Eosinophils, Period 1 Day 14 | Monocytes, Period 1 Day 7 | Monocytes, Period 1 Day 14 | Leukocytes, Period 1 Day 7 | Leukocytes, Period 1 Day 14 | Lymphocytes, Period 1 Day 7 | Lymphocytes, Period 1 Day 14 | Neutrophils, Period 1 Day 7 | Neutrophils, Period 1 Day 14 | Platelets, Period 1 Day 7 | Platelets, Period 1 Day 14 |
---|
TAF/FTC | -0.005 | -0.006 | -0.021 | -0.020 | 0.014 | 0.049 | -0.08 | 0.27 | -0.246 | -0.262 | 0.188 | 0.513 | 3.3 | 21.8 |
[back to top]
Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | pH (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | -0.34 | -0.19 |
[back to top]
Period 1: Change From Baseline in Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Beats per minute (Mean) |
---|
| Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | -1.2 | -3.8 | -4.0 | -1.6 | -7.6 |
[back to top]
Period 1: Change From Baseline in Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Breaths per minute (Mean) |
---|
| Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | -1.5 | -0.5 | -0.5 | 1.3 | 0.6 |
[back to top]
Period 1: Change From Baseline in Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Ratio (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.0007 | 0.0011 |
[back to top]
Period 1: Change From Baseline in Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Degree Celsius (Mean) |
---|
| Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | -0.16 | -0.15 | -0.09 | -0.15 | -0.24 |
[back to top]
Period 1: Change From Baseline in Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Micromoles per liter (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | -2.5395 | -2.5395 |
[back to top]
Period 2: Absolute Values of Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Breaths per minute (Mean) |
---|
| Baseline, n= 16 | Day 4, n=15 | Day 7, n=15 | Day 9, n=15 | Day 10, n=15 |
---|
TAF/FTC+GSK3640254 | 15.6 | 12.5 | 13.3 | 14.9 | 14.3 |
[back to top]
Period 2: Absolute Values of Blood Pressure
SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Baseline, n= 16 | SBP, Day 4, n=15 | SBP, Day 7, n=15 | SBP, Day 9, n=15 | SBP, Day 10, n=15 | DBP, Baseline, n= 16 | DBP, Day 4, n= 15 | DBP, Day 7, n= 15 | DBP, Day 9, n= 15 | DBP, Day 10, n= 15 |
---|
TAF/FTC+GSK3640254 | 120.4 | 119.3 | 120.8 | 117.9 | 123.7 | 74.4 | 74.3 | 77.9 | 70.3 | 72.1 |
[back to top]
Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Units per Liter (Mean) |
---|
| Amylase, Baseline, n= 16 | Amylase, Day 3, n= 16 | Amylase, Day 7, n= 15 | Amylase, Day 9, n= 15 | Lipase, Baseline, n= 16 | Lipase, Day 3, n= 16 | Lipase, Day 7, n= 15 | Lipase, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 53.6 | 56.8 | 52.7 | 55.7 | 16.9 | 24.6 | 17.5 | 21.0 |
[back to top]
Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | International units per Liter (Mean) |
---|
| Alkaline phosphatase, Baseline Day 3, n= 16 | Alkaline phosphatase, Day 3, n= 16 | Alkaline phosphatase, Day 7, n= 15 | Alkaline phosphatase, Day 9, n= 15 | AST, Baseline, n= 16 | AST, Day 3, n= 16 | AST, Day 7, n= 15 | AST, Day 9, n= 15 | ALT, Baseline, n= 16 | ALT, Day 3, n= 16 | ALT, Day 7, n= 15 | ALT, Day 9, n= 15 | GGT, Baseline, n= 16 | GGT, Day 3, n= 16 | GGT, Day 7, n= 15 | GGT, Day 9, n= 15 | LDH, Baseline, n= 16 | LDH, Day 3, n= 16 | LDH, Day 7, n= 15 | LDH, Day 9, n= 15 | CK, Baseline, n= 16 | CK, Day 3, n= 16 | CK, Day 7, n= 15 | CK, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 63.4 | 67.1 | 65.4 | 61.8 | 17.6 | 16.2 | 17.2 | 17.6 | 20.4 | 18.4 | 18.5 | 19.7 | 2.40 | 2.14 | 2.41 | 1.95 | 126.0 | 119.0 | 118.0 | 119.2 | 120.4 | 123.8 | 135.8 | 122.2 |
[back to top]
Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Millimoles per Liter (Mean) |
---|
| Glucose, Baseline, n= 16 | Glucose, Day 3, n= 15 | Glucose, Day 7, n= 15 | Glucose, Day 9, n= 15 | Cholesterol, Baseline, n= 16 | Cholesterol, Day 3, n=15 | Cholesterol, Day 7, n= 15 | Cholesterol, Day 9, n= 16 | Anion gap, Baseline, n= 16 | Anion gap, Day 3, n= 16 | Anion gap, Day 7, n= 15 | Anion gap, Day 9, n= 15 | Calcium, Baseline, n= 16 | Calcium, Day 3, n= 16 | Calcium, Day 7, n= 15 | Calcium, Day 9, n= 15 | CO2, Baseline, n= 16 | CO2, Day 3, n= 16 | CO2, Day 7, n= 15 | CO2, Day 9, n= 15 | Chloride, Baseline, n= 16 | Chloride, Day 3, n= 16 | Chloride, Day 7, n= 15 | Chloride, Day 9, n= 15 | Phosphate, Baseline, n= 16 | Phosphate, Day 3, n= 16 | Phosphate, Day 7, n= 15 | Phosphate, Day 9, n= 15 | Potassium, Baseline, n= 16 | Potassium, Day 3, n= 16 | Potassium, Day 7, n= 15 | Potassium, Day 9, n= 15 | Sodium, Baseline, n= 16 | Sodium, Day 3, n= 16 | Sodium, Day 7, n= 15 | Sodium, Day 9, n=15 | Triglycerides, Baseline, n= 16 | Triglycerides, Day 3, n= 16 | Triglycerides, Day 7, n= 15 | Triglycerides, Day 9, n= 15 | BUN, Baseline, n= 16 | BUN, Day 3, n= 16 | BUN, Day 7, n= 15 | BUN Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 4.791 | 5.027 | 5.129 | 4.950 | 3.864 | 3.875 | 3.894 | 3.822 | 10.9 | 10.5 | 10.3 | 10.5 | 2.387 | 2.399 | 2.424 | 2.421 | 30.8 | 30.3 | 30.7 | 30.5 | 101.3 | 103.6 | 101.9 | 102.7 | 1.103 | 1.165 | 1.112 | 1.117 | 4.22 | 4.23 | 4.21 | 4.35 | 138.8 | 140.2 | 138.8 | 139.3 | 1.033 | 1.029 | 1.120 | 0.961 | 4.246 | 4.558 | 4.260 | 4.263 |
[back to top]
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Creatinine, Baseline, n= 16 | Creatinine, Day 3, n= 16 | Creatinine, Day 7, n= 15 | Creatinine, Day 9, n= 15 | Total bilirubin, Baseline, n= 16 | Total bilirubin, Day 3, n= 16 | Total bilirubin, Day 7, n= 15 | Total bilirubin, Day 9, n= 15 | Direct bilirubin, Baseline, n= 16 | Direct bilirubin, Day 3, n= 16 | Direct bilirubin, Day 7, n= 15 | Direct bilirubin, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 87.52 | 85.18 | 91.53 | 88.27 | 11.44 | 10.62 | 11.33 | 9.68 | 2.40 | 2.14 | 2.41 | 1.95 |
[back to top]
Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin
Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per Liter (Mean) |
---|
| Total Protein, Baseline, n= 16 | Total Protein, Day 3, n= 16 | Total Protein, Day 7, n= 15 | Total Protein, Day 9, n= 15 | Globulin, Baseline, n= 16 | Globulin, Day 3, n= 16 | Globulin, Day 7, n= 15 | Globulin, Day 9, n= 15 | Albumin, Baseline, n= 16 | Albumin, Day 3, n= 16 | Albumin, Day 7, n= 15 | Albumin, Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 72.6 | 72.8 | 75.7 | 73.3 | 28.7 | 28.9 | 30.9 | 28.8 | 43.9 | 43.9 | 44.8 | 44.5 |
[back to top]
Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Milliseconds (Mean) |
---|
| PR Interval, Baseline, n= 16 | PR Interval, Day 1, 2 hours post-dose, n= 16 | PR Interval, Day 1, 4 hours post-dose, n= 16 | PR Interval, Day 4, Pre-dose, n= 15 | PR Interval, Day 4, 2 hours post-dose, n= 15 | PR Interval, Day 4, 4 hours post-dose, n= 15 | PR Interval, Day 7, Pre-dose, n= 15 | PR Interval, Day 7, 2 hours post-dose, n= 15 | PR Interval, Day 7, 4 hours post-dose, n= 15 | PR Interval, Day 9 post-dose, n= 15 | QRS Duration, Baseline, n= 16 | QRS Duration, Day 1, 2 hours post-dose, n= 16 | QRS Duration, Day 1, 4 hours post-dose, n= 16 | QRS Duration, Day 4, Pre-dose, n= 15 | QRS Duration, Day 4, 2 hours post-dose, n= 15 | QRS Duration, Day 4, 4 hours post-dose, n= 15 | QRS Duration, Day 7, Pre-dose, n= 15 | QRS Duration, Day 7, 2 hours post-dose, n= 15 | QRS Duration, Day 7, 4 hours post-dose, n= 15 | QRS Duration, Day 9 post-dose, n= 15 | QT Interval, Baseline, n= 16 | QT Interval, Day 1, 2 hours post-dose, n= 16 | QT Interval, Day 1, 4 hours post-dose, n= 16 | QT Interval, Day 4, Pre-dose, n= 15 | QT Interval, Day 4, 2 hours post-dose, n= 15 | QT Interval, Day 4, 4 hours post-dose, n= 15 | QT Interval, Day 7, Pre-dose, n= 15 | QT Interval, Day 7, 2 hours post-dose, n= 15 | QT Interval, Day 7, 4 hours post-dose, n= 15 | QT Interval, Day 9 post-dose, n= 15 | QTcF Interval, Baseline, n= 16 | QTcF Interval, Day 1, 2 hours, n= 16 | QTcF Interval, Day 1, 4 hours post-dose, n= 16 | QTcF Interval, Day 4, Pre-dose, n= 15 | QTcF Interval, Day 4, 2 hours post-dose, n= 15 | QTcF Interval, Day 4, 4 hours post-dose, n= 15 | QTcF Interval, Day 7, Pre-dose, n= 15 | QTcF Interval, Day 7, 2 hours post-dose, n= 15 | QTcF Interval, Day 7, 4 hours post-dose, n= 15 | QTcF Interval, Day 9 post-dose, n= 15 | QTcB Interval, Baseline, n= 16 | QTcB Interval, Day 1, 2 hours post-dose, n= 16 | QTcB Interval, Day 1, 4 hours post-dose, n= 16 | QTcB Interval, Day 4, Pre-dose, n= 15 | QTcB Interval, Day 4, 2 hours post-dose, n= 15 | QTcB Interval, Day 4, 4 hours post-dose, n= 15 | QTcB Interval, Day 7, Pre-dose, n= 15 | QTcB Interval, Day 7, 2 hours post-dose, n= 15 | QTcB Interval, Day 7, 4 hours post-dose, n= 15 | QTcB Interval, Day 9 post-dose, n= 15 |
---|
TAF/FTC+GSK3640254 | 167.3 | 160.4 | 163.6 | 167.1 | 160.7 | 163.7 | 164.9 | 164.3 | 163.9 | 168.8 | 91.4 | 88.9 | 90.1 | 91.8 | 91.8 | 91.1 | 94.5 | 92.7 | 91.6 | 94.3 | 377.7 | 365.1 | 375.9 | 385.6 | 371.5 | 383.9 | 381.7 | 369.9 | 384.1 | 382.4 | 390.0 | 385.6 | 392.4 | 395.0 | 388.3 | 393.4 | 393.0 | 383.8 | 389.5 | 396.8 | 395.7 | 396.4 | 400.4 | 399.2 | 396.2 | 398.0 | 398.3 | 390.5 | 391.9 | 404.0 |
[back to top]
Period 2: Absolute Values of Heart Rate
Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose
Intervention | Beats per minute (Mean) |
---|
| Baseline, n= 16 | Day 1, 2 hours post-dose, n= 16 | Day 1, 4 hours post-dose, n= 16 | Day 4, Pre-dose, n= 15 | Day 4, 2 hours post-dose, n= 15 | Day 4, 4 hours post-dose, n= 15 | Day 7, Pre-dose, n= 15 | Day 7, 2 hours post-dose, n= 15 | Day 7, 4 hours post-dose, n= 15 | Day 9 post-dose, n= 15 |
---|
TAF/FTC+GSK3640254 | 66.5 | 71.5 | 69.3 | 65.1 | 68.9 | 65.3 | 65.9 | 67.4 | 63.3 | 67.7 |
[back to top]
Period 2: Absolute Values of pH of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | pH (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 6.03 | 6.22 | 6.07 | 6.07 |
[back to top]
Period 2: Absolute Values of Pulse Rate
Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Beats per minute (Mean) |
---|
| Baseline, n= 16 | Day 4, n=15 | Day 7, n=15 | Day 9, n=15 | Day 10, n=15 |
---|
TAF/FTC+GSK3640254 | 70.5 | 71.9 | 71.4 | 69.2 | 79.0 |
[back to top]
Period 2: Absolute Values of Specific Gravity of Urine
Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Ratio (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 1.0147 | 1.0178 | 1.0170 | 1.0151 |
[back to top]
Period 2: Absolute Values of Temperature
Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Degree Celsius (Mean) |
---|
| Baseline, n= 16 | Day 4, n=15 | Day 7, n=15 | Day 9, n=15 | Day 10, n=15 |
---|
TAF/FTC+GSK3640254 | 36.49 | 36.37 | 36.40 | 36.46 | 36.53 |
[back to top]
Period 1: Absolute Values of pH of Urine
Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | pH (Mean) |
---|
| Baseline | Day 7 | Day 14 |
---|
TAF/FTC | 6.22 | 5.88 | 6.03 |
[back to top]
Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Giga cells per liter (Mean) |
---|
| Basophils, Period 2 Baseline, n= 16 | Basophils, Period 2 Day 3, n= 15 | Basophils, Period 2 Day 7, n= 15 | Basophils, Period 2 Day 9, n= 15 | Eosinophils, Period 2 Baseline, n= 16 | Eosinophils, Period 2 Day 3, n= 15 | Eosinophils, Period 2 Day 7, n= 15 | Eosinophils, Period 2 Day 9, n= 16 | Monocytes, Period 2 Baseline, n= 16 | Monocytes, Period 2 Day 3, n= 16 | Monocytes, Period 2 Day 7, n= 15 | Monocytes, Period 2 Day 9, n= 15 | Leukocytes, Period 2 Baseline, n= 16 | Leukocytes, Period 2 Day 3, n= 16 | Leukocytes, Period 2 Day 7, n= 15 | Leukocytes, Period 2 Day 9, n= 15 | Lymphocytes, Period 2 Baseline, n= 16 | Lymphocytes, Period 2 Day 3, n= 16 | Lymphocytes, Period 2 Day 7, n= 15 | Lymphocytes, Period 2 Day 9, n= 15 | Neutrophils, Period 2 Baseline, n= 16 | Neutrophils, Period 2 Day 3, n= 16 | Neutrophils, Period 2 Day 7, n= 15 | Neutrophils, Period 2 Day 9, n= 15 | Platelets, Period 2 Baseline, n= 16 | Platelets, Period 2 Day 3, n= 16 | Platelets, Period 2 Day 7, n= 15 | Platelets, Period 2 Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.040 | 0.036 | 0.038 | 0.043 | 0.208 | 0.185 | 0.157 | 0.153 | 0.545 | 0.492 | 0.448 | 0.421 | 6.20 | 5.14 | 5.39 | 5.51 | 1.718 | 1.560 | 1.570 | 1.563 | 3.724 | 2.857 | 3.189 | 3.324 | 274.3 | 283.4 | 294.0 | 290.4 |
[back to top]
Period 2: Absolute Values of the Hematology Parameter: Erythrocytes
Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Trillion cells per liter (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 5.203 | 5.090 | 5.190 | 5.001 |
[back to top]
Period 2: Absolute Values of the Hematology Parameter: Hematocrit
Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Proportion of red blood cells in blood (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 0.4453 | 0.4306 | 0.4444 | 0.4247 |
[back to top]
Period 2: Absolute Values of the Hematology Parameter: Hemoglobin
Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Grams per liter (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 150.4 | 146.4 | 149.1 | 143.9 |
[back to top]
Period 2: Absolute Values of the Hematology Parameter: MCH
Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Picograms (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 28.98 | 28.88 | 28.83 | 28.87 |
[back to top]
Period 2: Absolute Values of the Hematology Parameter: MCV
Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Femtoliters (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 85.85 | 84.83 | 85.85 | 85.20 |
[back to top]
Period 2: Absolute Values of Urine Urobilinogen
Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. (NCT03836729)
Timeframe: Baseline and at Days 3, 7, 9
Intervention | Micromoles per liter (Mean) |
---|
| Baseline, n= 16 | Day 3, n= 16 | Day 7, n= 15 | Day 9, n= 15 |
---|
TAF/FTC+GSK3640254 | 3.3860 | 3.3860 | 3.3860 | 3.3860 |
[back to top]
Period 2: Change From Baseline in Blood Pressure
SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 4, 7, 9, and 10
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Day 4 | SBP, Day 7 | SBP, Day 9 | SBP, Day 10 | DBP, Day 4 | DBP, Day 7 | DBP, Day 9 | DBP, Day 10 |
---|
TAF/FTC+GSK3640254 | -0.3 | 1.1 | -1.7 | 4.1 | 0.1 | 3.7 | -4.0 | -2.1 |
[back to top]
Period 1: Absolute Values of Respiratory Rate
Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Breaths per minute (Mean) |
---|
| Baseline | Day 2 | Day 3 | Day 4 | Day 5 | Day 7 |
---|
TAF/FTC | 14.0 | 12.5 | 13.5 | 13.5 | 15.3 | 14.6 |
[back to top]
Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)
Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value. (NCT03836729)
Timeframe: Baseline and at Days 7, 14
Intervention | Picograms (Mean) |
---|
| Day 7 | Day 14 |
---|
TAF/FTC | 0.13 | 0.36 |
[back to top]
Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 250.4 |
[back to top]
Period 1: AUC (0-tau) of FTC
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 9787.5 |
[back to top]
Period 1: AUC (0-tau) of Tenofovir (TFV)
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 221.9 |
[back to top]
Period 1: Cmax of TFV
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 13.14 |
[back to top]
Period 1: Ctau of TFV
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 7.688 |
[back to top]
Period 1: Maximum Observed Concentration (Cmax) of TAF
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 203.4 |
[back to top]
Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 71.81 |
[back to top]
Period 1: Tmax of FTC
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours (Median) |
---|
TAF/FTC | 1.500 |
[back to top]
Period 1: Tmax of TAF
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours (Median) |
---|
TAF/FTC | 1.00 |
[back to top]
Period 1: Tmax of TFV
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Hours (Median) |
---|
TAF/FTC | 3.000 |
[back to top]
Period 1:Cmax of FTC
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC | 1811 |
[back to top]
Period 2: AUC (0-tau) of FTC
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 9421.0 |
[back to top]
Period 2: AUC (0-tau) of GSK3640254
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 24.53 |
[back to top]
Period 2: AUC (0-tau) of TAF
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 215.4 |
[back to top]
Period 2: AUC (0-tau) of TFV
Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours*nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 229.1 |
[back to top]
Period 2: Cmax of GSK3640254
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 1.411 |
[back to top]
Period 2: Cmax of TAF
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 175.1 |
[back to top]
Period 2: Cmax of TFV
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 13.30 |
[back to top]
Period 2: Ctau of FTC
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 82.92 |
[back to top]
Period 2: Ctau of GSK3640254
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 0.7883 |
[back to top]
Period 2: Ctau of TFV
Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 8.244 |
[back to top]
Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 5.000 |
[back to top]
Period 2: Tmax of FTC
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 1.500 |
[back to top]
Period 2: Tmax of TAF
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 1.000 |
[back to top]
Period 2: Tmax of TFV
Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Hours (Median) |
---|
TAF/FTC+GSK3640254 | 3.000 |
[back to top]
Period 2:Cmax of FTC
Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis. (NCT03836729)
Timeframe: Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7
Intervention | Nanogram per milliliter (Geometric Mean) |
---|
TAF/FTC+GSK3640254 | 1701 |
[back to top]
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)
An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before (NCT03836729)
Timeframe: Up to Day 24
Intervention | Participants (Number) |
---|
| Non-SAEs | SAEs |
---|
TAF/FTC | 9 | 0 |
,TAF/FTC+GSK3640254 | 3 | 0 |
[back to top]
Period 1: Absolute Values of Blood Pressure
SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. (NCT03836729)
Timeframe: Baseline and at Days 2, 3, 4, 5 and 7
Intervention | Millimeters of mercury (Mean) |
---|
| SBP, Baseline | SBP, Day 2 | SBP, Day 3 | SBP, Day 4 | SBP, Day 5 | SBP, Day 7 | DBP, Baseline | DBP, Day 2 | DBP, Day 3 | DBP, Day 4 | DBP, Day 5 | DBP, Day 7 |
---|
TAF/FTC | 123.3 | 124.7 | 121.5 | 120.6 | 121.0 | 124.1 | 75.3 | 75.4 | 73.8 | 75.4 | 73.9 | 78.2 |
[back to top]
Average Testosterone Concentrations in Serum.
Average testosterone concentrations in serum measured in ng/mL (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 55.45 |
[back to top]
Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.
Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 2-5
Intervention | fmol/million cells (Mean) |
---|
Tenofovir/Emtricitabine | 13.005 |
[back to top]
Average Emtricitabine Concentrations in Plasma.
Average emtricitabine concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 78.07 |
[back to top]
Average Emtricitabine Concentrations in Peripheral Blood Mononuclear Cells.
Average emtricitabine concentrations in peripheral blood mononuclear cells reported in Fmol/million cells. (NCT03917420)
Timeframe: Day 5
Intervention | Fmol/million cells (Mean) |
---|
Tenofovir/Emtricitabine | 5601.95 |
[back to top]
Average Emtricitabine Triphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.
Average emtricitabine triphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 12-15
Intervention | fmol/million cells (Mean) |
---|
Tenofovir/Emtricitabine | 74.822 |
[back to top]
Average Estradiol Concentrations in Serum.
Average estradiol concentrations in serum reported in pg/mL (NCT03917420)
Timeframe: Day 5
Intervention | pg/ml (Mean) |
---|
Tenofovir/Emtricitabine | 101.06 |
[back to top]
Average Progesterone Concentrations in Serum.
Average progesterone concentrations in serum measured in ng/mL. (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 2.46 |
[back to top]
Average Tenofovir Concentrations in Plasma.
Average tenofovir concentrations in plasma reported in ng/mL. (NCT03917420)
Timeframe: Day 5
Intervention | ng/ml (Mean) |
---|
Tenofovir/Emtricitabine | 61.02 |
[back to top]
Average Tenofovir Diphosphate Concentrations in Mixed Rectal Cells During the Early (Low Estradiol) Follicular Phases of the Menstrual Cycle.
Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the early (low estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells. (NCT03917420)
Timeframe: Days 2-5
Intervention | fmol/million cells (Mean) |
---|
Tenofovir/Emtricitabine | 406.14 |
[back to top]
Average Tenofovir Diphosphate Concentrations in Peripheral Blood Mononuclear Cells.
Average tenofovir diphosphate concentrations in peripheral blood mononuclear cells reported in Fmol/million cells. (NCT03917420)
Timeframe: Day 5
Intervention | Fmol/million cells (Mean) |
---|
Tenofovir/Emtricitabine | 96.40 |
[back to top]
Average Tenofovir Diphosphate Concentrations Measured in Mixed Rectal Cells During the Late (High Estradiol) Follicular Phases of the Menstrual Cycle.
Average tenofovir diphosphate concentrations measured in mixed rectal cells collected via cytobrush during the late (high estradiol) follicular phases of the menstrual cycle reported in Fmol/million cells (NCT03917420)
Timeframe: Days 12-15
Intervention | fmol/million cells (Mean) |
---|
Tenofovir/Emtricitabine | 480.4 |
[back to top]
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 116.5 |
[back to top]
Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 9.25 | 0 |
[back to top]
Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 1.23 | 0.02 |
[back to top]
Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 9.54 | 0.02 |
[back to top]
Rectal Tissue Concentration of Emtricitabine (FTC)
Median drug concentrations in rectal tissue of the FTC component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0.17 |
[back to top]
Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 41.47 | 0 |
[back to top]
Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 0.60 | 0.02 |
[back to top]
Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 51.23 | 1.03 |
[back to top]
Rectal Tissue Concentration of Elvitegravir (EVG)
Median drug concentrations in rectal tissue of the EVG component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0.31 |
[back to top]
Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 0 | 0 |
[back to top]
Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 0 | 0 |
[back to top]
Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 0 | 0 |
[back to top]
Plasma Concentration of Tenofovir (TFV)
Median drug concentrations of the TFV component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0 |
[back to top]
Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 1725 | 0 |
[back to top]
Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 113 | 0 |
[back to top]
Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 2710 | 0 |
[back to top]
Plasma Concentration of Emtricitabine (FTC)
Median drug concentrations of the FTC component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 300 |
[back to top]
Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 1818 | 0 |
[back to top]
Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 0.01 |
[back to top]
Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 2243 | 0 |
[back to top]
Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 283 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 621 | 158 |
[back to top]
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 45.9 | 11.9 |
[back to top]
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 20.2 | 14.7 |
[back to top]
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 39.1 | 18.2 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 569 | 291 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 375 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 4 hour | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 7800 | 955 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 5140 | 714 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 7705 | 2120 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Emtricitabine-triphosphate (FTC-TP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, NK cells) and monocytes. Median drug levels were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 6855 |
[back to top]
Rectal Tissue Concentration of Tenofovir-diphosphate (TFV-DP)
Median drug concentrations of TFV-DP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 8 hours |
---|
Genvoya - Single Time Point Specimen Collection | 0 | 23.7 |
[back to top]
Plasma Concentration of Elvitegravir (EVG)
Median drug concentrations of the EVG component of Genvoya were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mL (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 232 | 0 |
[back to top]
Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 0.30 | 0 |
[back to top]
Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 0.03 | 0 |
[back to top]
Rectal Tissue Concentration of Tenofovir (TFN)
Median drug concentrations in rectal tissue of the TFN component of Genvoya were determined at baseline and at each of the protocol specified time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | ng/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 0 | 0 |
[back to top]
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 4 hours | 72 hours |
---|
Genvoya - 4 and 72 Hours Specimen Collection | 0 | 198.2 | 15.1 |
[back to top]
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 104.3 | 12.5 |
[back to top]
Rectal Tissue Concentration of Emtricitabine-triphosphate (FTC-TP)
Median drug concentrations of FTC-TP in rectal tissue were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/mg (Median) |
---|
| Baseline | 2 hours | 48 hours |
---|
Genvoya - 2 and 48 Hours Specimen Collection | 0 | 187.5 | 56.3 |
[back to top]
Peripheral Blood Mononuclear Cell (PBMC) Concentration of Tenofovir-diphosphate (TFV-DP)
A peripheral blood mononuclear cell (PBMC) is any peripheral blood cell having a round nucleus: lymphocytes (T cells, B cells, natural killer (NK) cells) and monocytes. Median drug concentrations were determined at baseline and at each of the protocol specified follow-up time points. Concentrations below the limit of quantification (LOQ) are assigned a value of zero. (NCT03976752)
Timeframe: Baseline, and 2, 4, 8, 24, 48, 72, 96 hours after taking the second dose of medication
Intervention | fmol/10^6 cells (Median) |
---|
| Baseline | 24 hours | 96 hours |
---|
Genvoya - 24 and 96 Hours Specimen Collection | 0 | 429 | 117 |
[back to top]
Percentage of Participants With Grade 3 or Greater Adverse Events
The percentage of participants experiencing grade 3 or greater adverse events at Week 24 (NCT03998176)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 12 |
[back to top]
Percentage of Participants With Grade 3 or Greater Adverse Events
The percentage of participants experiencing grade 3 or greater adverse events at Week 48 (NCT03998176)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 15 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 analyzed by the snapshot algorithm, which defines a participants virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03998176)
Timeframe: Week 24
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 32 |
[back to top]
Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm
The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 analyzed by the snapshot algorithm, which defines a participants virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. (NCT03998176)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
B/F/TAF | 21 |
[back to top]
Total Testosterone
Total testosterone concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF
Intervention | ng/dL (Median) |
---|
| Week 0 | Week 4 |
---|
Transgender Men | 559 | 595 |
,Transgender Women | 56.5 | 56.7 |
[back to top]
Estradiol Concentration
Estradiol concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF
Intervention | pg/mL (Median) |
---|
| Week 0 | Week 4 |
---|
Transgender Men | 24.2 | 23.1 |
,Transgender Women | 141.5 | 116 |
[back to top]
Tenofovir Diphosphate Concentration in Dried Blood Spots (DBS)
Tenofovir diphosphate concentration in dried blood spots at week 4 (NCT04050371)
Timeframe: After 4 weeks of daily observed dosing of FTC/TDF
Intervention | fmol/punch (Median) |
---|
Transgender Women | 973.5 |
Transgender Men | 1078 |
[back to top]
Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit
This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | pg/mL (Geometric Mean) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 529.4 | 492.0 | 457.0 | 418.9 | 402.8 | 20.0 |
[back to top]
Geometric Mean of Maternal DPV Concentrations From Plasma by Visit
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | pg/mL (Geometric Mean) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 327.9 | 314.9 | 275.4 | 263.8 | 260.4 | 16.7 |
[back to top]
Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit
This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | mg/mL (Geometric Mean) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 552.6 | 447.6 | 319.9 | 313.0 | 296.6 | 2.8 |
[back to top]
Geometric Mean of Infant DPV Concentrations From Plasma by Visit
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | pg/mL (Geometric Mean) |
---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Infants - Group A: DPV VR | 11.7 | 11.5 | 11.0 | 10.5 | 10 |
[back to top]
Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods
"Based on participant report on the question Overall, how much did you like using the study product? on the Product End Use Visit Behavioral Assessment." (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 141 |
Mothers - Group B: Truvada Tablet | 46 |
[back to top]
Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 47 | 48 | 45 | 44 | 47 | 45 |
[back to top]
The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product
The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs <= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations < 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study. (NCT04140266)
Timeframe: Measured through Month 3
Intervention | Participants (Count of Participants) |
---|
| Month 1 | Month 2 | Month 3 |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 14 | 28 | 29 |
,Mothers - Group B: Truvada Tablet | 2 | 0 | 0 |
[back to top]
Residual Drug Levels in Returned VRs
The residual DPV concentrations from the returned VRs are summarized. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | mg (Median) |
---|
| Month 1 | Month 2 | Month 3 |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 22.1 | 22.4 | 22.1 |
[back to top]
Geometric Mean of Infant FTC-TP Concentration by Visit
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | pmol/punch (Geometric Mean) |
---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Infants - Group B: Truvada Tablet | 0.1 | 0.1 | 0.1 | 0.1 | 0.1 |
[back to top]
Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N)
"Based on participant report to the question Would you be willing to use the study product for HIV prevention while breastfeeding in the future?" (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 142 |
Mothers - Group B: Truvada Tablet | 48 |
[back to top]
Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms
As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010) (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 2 |
Mothers - Group B: Truvada Tablet | 0 |
[back to top]
Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms
As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
Infants - Group A: DPV VR | 10 |
Infants - Group B: Truvada Tablet | 1 |
[back to top]
Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms
As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]) (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 3 |
Group B: Truvada Tablet | 2 |
[back to top]
Geometric Mean of Maternal FTC-TP Concentrations by Visit
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | pmol/punch (Geometric Mean) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 0.3 | 0.3 | 0.3 | 0.2 | 0.2 | 0.1 |
[back to top]
Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms
As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010) (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
Infants - Group A: DPV VR | 4 |
Infants - Group B: Truvada Tablet | 0 |
[back to top]
Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 139 | 136 | 139 | 138 | 136 | 48 |
[back to top]
Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 45 | 46 | 38 | 34 | 38 | 1 |
[back to top]
Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations
This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 47 | 44 | 42 | 38 | 38 | 3 |
[back to top]
Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations
This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 47 | 45 | 44 | 39 | 40 | 1 |
[back to top]
Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations
This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004 | 137 | 137 | 138 | 138 | 135 | 94 |
[back to top]
Number and Proportion of Infants With Detectable TFV-DP Concentrations
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study Exit Visit |
---|
Infants - Group B: Truvada Tablet | 0 | 0 | 0 | 0 | 0 |
[back to top]
Number and Proportion of Infants With Detectable Plasma DPV Concentrations
This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study Exit Visit |
---|
Infants - Group A: DPV VR | 21 | 20 | 14 | 7 | 0 |
[back to top]
Geometric Mean of Infant TFV-DP Concentrations by Visit
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | fmol/punch (Geometric Mean) |
---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Infants - Group B: Truvada Tablet | 15.6 | 15.6 | 15.6 | 15.6 | 15.6 |
[back to top]
Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit
This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | ng/mL (Geometric Mean) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 5.6 | 4.3 | 3.3 | 3.2 | 2.7 | 0.6 |
[back to top]
Geometric Mean of Maternal TFV-DP Concentrations by Visit
This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | fmol/punch (Geometric Mean) |
---|
| Week 1 | Week 2 | Month 1 | Month 2 | Product Use End Visit | Study End Visit |
---|
Mothers - Group B: Truvada Tablet | 254.6 | 424.2 | 524.7 | 551.9 | 591.5 | 330.8 |
[back to top]
Number and Proportion of Infants With Detectable FTC-TP Concentrations
This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above. (NCT04140266)
Timeframe: Measured through Month 3.5
Intervention | Participants (Count of Participants) |
---|
| Week 2 | Month 1 | Month 2 | Product Use End Visit | Study Exit Visit |
---|
Infants - Group B: Truvada Tablet | 4 | 2 | 2 | 1 | 0 |
[back to top]
Percentage of Participants Who Experienced an Adverse Event (AE) up to Week 48
An AE is any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who experience an AE was reported. (NCT04233879)
Timeframe: Up to approximately 48 weeks
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 90.6 |
Group 2: BIC/FTC/TAF | 86.3 |
[back to top]
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <200 copies/mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 will be presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 89.6 |
Group 2: BIC/FTC/TAF | 88.6 |
[back to top]
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA <40 copies/mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 will be presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 88.6 |
Group 2: BIC/FTC/TAF | 86.3 |
[back to top]
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott Real Time polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was presented using the FDA Snapshot missing data approach. (NCT04233879)
Timeframe: Week 48
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 88.9 |
Group 2: BIC/FTC/TAF | 88.3 |
[back to top]
Change From Baseline in Body Weight at Week 48
Body weight was measured at baseline and at Week 48. Baseline measurements were defined as the Day 1 value of each participant. The change from baseline in body weight at Week 48 was presented. (NCT04233879)
Timeframe: Baseline (Day 1) and Week 48
Intervention | kilogram (Mean) |
---|
Group 1: DOR/ISL | 3.45 |
Group 2: BIC/FTC/TAF | 3.32 |
[back to top]
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 48
Plasma CD4+ T-cell count was measured in cells/mm^3 for baseline and 48 weeks by a central laboratory. Baseline measurements were defined as the Day 1 value of each participant. The mean change from baseline in CD4+ T-cell count at Week 48 was presented. (NCT04233879)
Timeframe: Baseline (Day 1) and Week 48
Intervention | cells/mm^3 (Mean) |
---|
Group 1: DOR/ISL | 182.4 |
Group 2: BIC/FTC/TAF | 233.5 |
[back to top]
Incidence of Viral Resistance-Associated Substitutions (RASs) at Week 48
RASs was defined as participants with confirmed HIV-1 RNA ≥200 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated RASs at Week 48 was presented. (NCT04233879)
Timeframe: Week 48
Intervention | Participants (Count of Participants) |
---|
Group 1: DOR/ISL | 1 |
Group 2: BIC/FTC/TAF | 0 |
[back to top]
Percentage of Participants Who Discontinued Study Treatment Due to an AE up to Week 48
An AE is any untoward medical occurrence in a study participant administered a study drug, which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug whether or not it is considered related to the study drug. The percentage of participants who discontinued study treatment due to an AE were reported. (NCT04233879)
Timeframe: Up to approximately 48 weeks
Intervention | Percentage of participants (Number) |
---|
Group 1: DOR/ISL | 7.4 |
Group 2: BIC/FTC/TAF | 3.3 |
[back to top]
Extracellular Tenofovir (TFV) for Recent Drug Exposure
"Dried blood spots were collected at each monthly study visit to characterize drug adherence by measuring extracellular tenofovir (TFV) for recent drug exposure (~24 hours). Of 229 participants, 196 participants had monthly DBSs available for analysis. A sampling algorithm was designed to make inference to TFV and TFV-DP levels at all 12 months. For the TFV extracellular analysis, participants were randomly assigned to one of three sampling schedules, with equal probability: (a) months 1, 2, 5, 8, and 11; (b) months 1, 3, 6, 9, and 12; and (c) months 1, 4, 7, 10, and 12. These 196 participants contributed a total of 777 monthly DBSs for the TFV extracellular analysis.~Extracellular TFV detectability was defined as having a mean TFV level (of up to four measurements) equal to or greater than 5 ng/mL." (NCT04318210)
Timeframe: Up to 12 months
Intervention | number of DBS samples (Number) |
---|
| Detectable TFV | No detectable TFV |
---|
TDF-FTC as PrEP | 713 | 64 |
[back to top]
Self-reported Drug Adherence Over the Past 3 Days
"A 30-day supply of TDF/FTC was dispensed at each monthly visit, for up to 12 months.~Participants were asked monthly about their drug adherence and were asked to recall their time of dosing over the past 3 days.~Question: Please think back to [yesterday, 2 days ago, 3 days ago]. What time did you take Truvada? Was it in the morning, afternoon, evening, or you weren't able to take the pill that day?" (NCT04318210)
Timeframe: Up to 12 Months
Intervention | Participants (Count of Participants) |
---|
| Took daily dosage in past 3 days | Took 2 doses in past 3 days | Took 1 doses in past 3 days | No doses taken in past 3 days |
---|
TDF-FTC as PrEP | 199 | 9 | 2 | 19 |
[back to top]
Number of Sex Partners
"Number of sex partners was assessed at baseline and each scheduled monthly visit, for up to 12 months.~Responses to the following question refers to the number of partners reported in the past 30 days:~In the past 30 days, with how many partners have you had sexual intercourse?" (NCT04318210)
Timeframe: Up to 12 months
Intervention | sexual partners (Mean) |
---|
| Number of sex partners among women, overall | Number of sex partners among men, overall |
---|
TDF-FTC as PrEP | 0.87 | 1.03 |
[back to top]
Number of Sex Acts by Condom Usage
"Number of sex acts by condom usage was assessed at baseline and each scheduled monthly visit, for up to 12 months.~Responses to the following question refers to the number of sex acts with up to 3 partners.~In the past 30 days, how many times did you have sex with ['this partner']? When I ask about the number of times you had sex, please count each sexual act. For example, if you had 2 rounds of sexual intercourse with your partner on a single evening, count that as two times you had sex. Please remember that this only refers to vaginal and anal sex. It does not refer to oral sex.~To assess condom use by sex act, the following question was asked to assess the number of sex acts with condoms and without condoms with up to 3 partners:~Of the ___ sex acts, how many times did you not use condoms the entire time?" (NCT04318210)
Timeframe: Up to 12 months
Intervention | sex acts (Mean) |
---|
| Number of sex acts among women | Number of sex acts among men | Number of condomless sex acts among women | Number of condomless sex acts among men | Number of sex acts involving a condom among women | Number of sex acts involving a condom among men |
---|
TDF-FTC as PrEP | 4.01 | 5.95 | 1.28 | 1.70 | 2.72 | 4.24 |
[back to top]
Intracellular Tenofovir-diphosphate (TFV-DP)
Dried blood spots were collected at each monthly study visit to characterize drug adherence by measuring intracellular tenofovir-diphosphate (TFV-DP) for long-term drug exposure (~7 days). The 196 participants who had monthly DBSs available were stratified by site, gender, and the 3 patterns previously assigned for the TFV extracellular analysis (2×2×3 = 12 strata). Then 60 participants were selected, 5 from each of the 12 strata, to balance by site, gender, and the above 3 patterns were maintained. In turn, the monthly DBSs indicated by the assigned pattern were analyzed. These 60 participants contributed a total of 237 monthly DBSs for the TFV-DP intracellular analysis. The observed TFV-DP levels in our study population were categorized as follows (units of drug in fmol/mL): 0 doses per week (<912); 1 dose taken per week (≥912 and <1824); 2 doses taken per week (≥1824 and <2688); 3 doses taken per week (≥2688 and <3600); 4 doses taken per week (≥3600 and <4464); 5 to 7 doses taken (NCT04318210)
Timeframe: Up to 12 months
Intervention | number of DBS samples (Number) |
---|
| 7 doses per week | 6 doses per week | 5 doses per week | 4 doses per week | 3 doses per week | 2 doses per week | 1 dose per week | 0 doses per week |
---|
TDF-FTC as PrEP | 141 | 29 | 20 | 6 | 12 | 4 | 5 | 19 |
[back to top]
HIV Seroconversion
Study visits were scheduled every month until completion of the study and during monthly study visits, HIV testing was performed, for up to 12 months. During monthly visits, routine HIV testing was performed with two HIV rapid tests. If HIV-infection was suspected, HIV antigen-antibody (Ag/Ab) combination enzyme immunoassay (EIA) (Bio-Rad, GS HIV Combo Ag/Ab EIA) testing was performed, and RNA viral load was measured. (NCT04318210)
Timeframe: Up to 12 Months
Intervention | Participants (Count of Participants) |
---|
TDF-FTC as PrEP | 0 |
[back to top]
Serious Adverse Events
Study visits were scheduled every month until study completion. Participants were instructed to return to the clinic for evaluation in event of illness. Participants reported any adverse effects (AEs) at monthly or interim visits and were determined as serious adverse events (SAE) when at least possibly related to study drug. DAIDS Table for Grading Severity of Adult Adverse Experiences for Vaccine & Prevention Research Programs was used for grading. Definitions: Grade 3-'probably related'-strong temporal relationship to study product that cannot be explained by participant's clinical state or other factors and a causal relationship is biologically plausible. Grade 4-'definitely related'-distinct temporal relationship to administration of the study product that cannot be explained by the participant's clinical state or other factors or AE occurs on re-challenge or the AE is a known reaction to the product or chemical group or can be predicted by the product's pharmacology. (NCT04318210)
Timeframe: Up to 12 Months
Intervention | participants (Number) |
---|
| Hyperamylasemia, Grade 3 | Hypophosphatemia, Grade 3 | Hypercreatininemia, Grade 1 |
---|
TDF-FTC as PrEP | 2 | 5 | 1 |
[back to top]