adenine and Nausea

adenine has been researched along with Nausea in 11 studies

Nausea: An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Research

Studies (11)

Authors

Clinical Trials (25)

Trial Overview

Trial Outcomes

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

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

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

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

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

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

Change From Baseline in CD4+ Cell Count at Week 144

(NCT01780506)
Timeframe: Baseline; Week 144

Change From Baseline in CD4+ Cell Count at Week 48

(NCT01780506)
Timeframe: Baseline; Week 48

Change From Baseline in CD4+ Cell Count at Week 96

(NCT01780506)
Timeframe: Baseline; Week 96

Change From Baseline in Serum Creatinine at Week 144

(NCT01780506)
Timeframe: Baseline; Week 144

Change From Baseline in Serum Creatinine at Week 48

(NCT01780506)
Timeframe: Baseline; Week 48

Change From Baseline in Serum Creatinine at Week 96

(NCT01780506)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip BMD at Week 144

Hip BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 144

Percent Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT01780506)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 144

Spine BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 144

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan. (NCT01780506)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 144

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 144

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01780506)
Timeframe: Baseline; Week 48

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. (NCT01780506)
Timeframe: Week 48

Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01780506)
Timeframe: Up to 144 weeks

Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01780506)
Timeframe: Up to 48 weeks

Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01780506)
Timeframe: Up to 96 weeks

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were analyzed using the snapshot algorithm, which defines a patient'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. (NCT01780506)
Timeframe: Weeks 48, 96. and 144

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were analyzed using the snapshot algorithm, which defines a patient'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. (NCT01780506)
Timeframe: Weeks 96 and 144

Change From Baseline in CD4+ Cell Count at Week 48

(NCT01797445)
Timeframe: Baseline; Week 48

Change From Baseline in CD4+ Cell Count at Week 96

(NCT01797445)
Timeframe: Baseline; Week 96

Change From Baseline in Serum Creatinine at Week 48

(NCT01797445)
Timeframe: Baseline; Week 48

Change From Baseline in Serum Creatinine at Week 96

(NCT01797445)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan. (NCT01797445)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. (NCT01797445)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan. (NCT01797445)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan. (NCT01797445)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 48

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 96

Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury. (NCT01797445)
Timeframe: Baseline; Week 48

Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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. (NCT01797445)
Timeframe: Week 48

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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. (NCT01797445)
Timeframe: Week 96

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient'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. (NCT01797445)
Timeframe: Weeks 48 and 96

Percentage of Participants With Treatment-emergent Proteinuria Through Week 48

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01797445)
Timeframe: Baseline to Week 48

Percentage of Participants With Treatment-emergent Proteinuria Through Week 96

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant. (NCT01797445)
Timeframe: Baseline to Week 96

Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT)

Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported. (NCT01611090)
Timeframe: Baseline to EOT (Up to 2 years)

Change From Baseline in EORTC QLQ-C30 Physical Functioning Score at End of Treatment

"EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms." (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Utility Score Scale at End of Treatment

The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1. High score indicating a high level of utility. (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)

Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale at End of Treatment

The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)

Change From Baseline in FACIT-Fatigue Scale at End of Treatment

FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)

Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale

Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5-point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). (NCT01611090)
Timeframe: Up to 2 years

Number of Participants Who Received Subsequent Antineoplastic Therapy

Number of participants who received subsequent antineoplastic therapy was reported. (NCT01611090)
Timeframe: Up to 5 years

Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms

The disease-related symptoms included fatigue, weight loss, fevers, night sweats, abdominal discomfort/splenomegaly and anorexia. (NCT01611090)
Timeframe: From the date of randomization to disease progression (Up to 2 years)

Overall Response Rate (ORR)

ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: >=50% decrease in ALC, >=50% decrease in sum products of up to 6 lymph nodes, >=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils >1.5*10^9/L, Platelets >100*10^9/L and Hgb>11 g/dL or >=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly. (NCT01611090)
Timeframe: Up to 5 years

Overall Survival (OS)

OS was defined as the interval between the date of randomization and the date of death from any cause. (NCT01611090)
Timeframe: Up to 5 years

Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response

MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia [CLL] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders. (NCT01611090)
Timeframe: Up to 5 years

Progression-free Survival (PFS)

PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); >=50% increase in existing lymph nodes; >=50% increase in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) or >=50% increase from nadir count confirmed on >=2 serial assessments if absolute lymphocyte count (ALC) >=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b [Hgb] or platelets) attributable to CLL; and transformation to a more aggressive histology. (NCT01611090)
Timeframe: Up to 5 years

Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment

The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much). (NCT01611090)
Timeframe: Baseline to EOT (up to 2 years)

Percentage of Participants With Sustained Hematologic Improvement

Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline. (NCT01611090)
Timeframe: Up to 5 years

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

Percent of Participants That Adhered to PrEP Over the Past Seven Days for Participants That Initiated PrEP

Participants will be asked to self-report their PrEP use over the past seven days on a follow up questionnaire. (NCT04048382)
Timeframe: 3 months

Percent of Participants That Attended an Appointment for PrEP Consultation.

Participants will be asked if they have attended an appointment for PrEP consultation on a follow up questionnaire. It will be confirmed by reviewing their medical records. (NCT04048382)
Timeframe: 3 months

Percent of Participants That Filled Their PrEP Prescription.

Participants will be asked if they have filled their PrEP prescription on a follow up questionnaire. It will be confirmed by reviewing their medical records. (NCT04048382)
Timeframe: 3 months

Percent of Participants That Initiated PrEP Use.

Participants will be asked to self-report their PrEP initiation on a follow up questionnaire. (NCT04048382)
Timeframe: 3 months

Percent of Participants That Received a PrEP Prescription.

Participants will be asked if they have received a PrEP prescription on a follow up questionnaire. It will be confirmed by reviewing their medical records. (NCT04048382)
Timeframe: 3 months

Percent of Participants That Scheduled an Appointment for PrEP Consultation.

Participants will be asked if they have scheduled an appointment for PrEP consultation on a follow up questionnaire. It will be confirmed by reviewing their medical records. (NCT04048382)
Timeframe: 3 months

ARV (TFV-DP) Levels

Intracellular TFV-DP will be measured in red blood cells using dried blood spots. TFV-DP levels provide a measure of long-term adherence over the preceding month (like hemoglobin A1C). The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average). (NCT02611362)
Timeframe: 24 weeks

HIV Knowledge at 24 Weeks

"The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 5 items with true, false, or do not know response options. Total scores range from 0 to 5. Higher scores indicate greater knowledge." (NCT02611362)
Timeframe: 24 weeks

Motivational Readiness for Adherence at 24 Weeks

Rollnick's Readiness Ruler will be used to assess motivation for adherence to medication and medical visits. Respondents rate how ready they are to take PrEP as prescribed on a scale from 1 (not ready) to 10 (ready to be consistent or already consistent) each month. (NCT02611362)
Timeframe: 24 weeks

Social Support for Medication Adherence

This six item measure assesses social support for taking medications, going to medical appointments and other tasks related to adherence using Likert style items with a four point scale. Scores range from 6 to 24 Higher scores indicate greater social support. (NCT02611362)
Timeframe: 24 weeks

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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

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)

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)

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)

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)

Duration of PrEP Use

Mean duration of interruptions (NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Duration of PrEP Use

Number of study drug interruptions (NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected

(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Measurement of PrEP Adherence by Medication Possession Ratio

Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits (NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Measurement of Acceptance Rate of PrEP

(NCT01632995)
Timeframe: Measured through enrollment (Week 0)

Measurement of PrEP Adherence by TFV-DP Levels in DBS

(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Measurement of Refusal Rate of PrEP

(NCT01632995)
Timeframe: Measured through enrollment (Week 0)

Measurement of Side Effects/Toxicities

(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Number of Male Sexual Partners

(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Number of Participants Who Seroconvert

(NCT01632995)
Timeframe: Participants were followed for 48 weeks, or up to the point of early termination

Affect Dysregulation Scale

"A six-item scale assessing adolescents' perceived abilities to manage emotional upset (e.g., In the past three months, I have had trouble controlling my feelings.) in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations." (NCT02921841)
Timeframe: 3 months post-intervention (average 6 months)

Condom Use Intention

"On a scale of 0 to 100, participants report how likely it is that they will use a condom when they have sex in the next 3 months. Zero represented I will not use a condom, 50 represented I will use a condom half the time., and 100 represented I will use a condom all the time.." (NCT02921841)
Timeframe: 3-months post-intervention

Frequency of Condom Use

Number of times a condom was used during oral, vaginal, and/or anal sex (NCT02921841)
Timeframe: 3-months post-intervention

Frequency of Recent Alcohol Use

Number of days alcohol was used in the past 30 days (NCT02921841)
Timeframe: 3-months post-intervention

Frequency of Recent Marijuana Use

Number of days marijuana was used in the past 30 days (NCT02921841)
Timeframe: 3-months post-intervention

Frequency of Sexual Intercourse

Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months. (NCT02921841)
Timeframe: 3-months post-intervention

HIV Knowledge

HIV Knowledge Questionnaire. A 18-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness. Scores range from 0-18 with higher scores indicating greater HIV knowledge. (NCT02921841)
Timeframe: 3 months post-intervention

Number of Sexual Partners

Number of sexual partners in the past 3 months. (NCT02921841)
Timeframe: 3-months post-intervention

Quantity of Recent Alcohol Use

Number of drinks reported on days that a participant drank alcohol in the past 30 days (NCT02921841)
Timeframe: 3-months post-intervention

Self-efficacy for HIV Prevention

"The scale contains 13 items that reflect the context of condom use, such as could use a condom when I'm very upset. Scores range from 13 to 52 with higher scores indicated lower self-efficacy for HIV prevention." (NCT02921841)
Timeframe: 3 months post-intervention

Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase

Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US. (NCT02165202)
Timeframe: Up to 52 weeks

Number of Adverse Events Based on PE, Blood Test and Event Reporting on Raltegravir Based PrEP, in HIV Negative Individuals

Subject safety and tolerability will be determined by physical examination, blood tests and adverse event reporting. FBC, U&E and LFTs will be carried out at baseline and thereafter as symptom directed. Adverse event review. If significant adverse events have been reported, these will be clinically followed in accordance to the instruction of the study physician. (NCT03205566)
Timeframe: Through Study completion, an average of 55 days

The Level of Raltegravir Alone or Raltegravir /Lamivudine Required in the Plasma, Vagina and Rectum for 100% ex Vivo Protection From HIV

"The level of Raltegravir alone or Raltegravir /lamivudine required in the plasma, vagina and rectum for 100% ex vivo protection from HIV .~High viral dose challenge: ex vivo challenge of tissue with 104 TCID50/mL HIV-1BaL Low viral dose challenge: ex vivo challenge of tissue with 102 TCID50/mL HIV-1BaL" (NCT03205566)
Timeframe: Through Study completion, an average of 55 days

The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.

Time in days from first receipt of antiretroviral (Raltegravir 400mg +/-lamivudine) until maximal ex vivo protection (against high or low titre of HIV-1BaL) was observed. (NCT03205566)
Timeframe: Up to 7 days from first dose

The Time From First Dose of Drug to Maximum Mucosal ex Vivo Protection From HIV.

Time in days from first receipt of antiretroviral (Raltegravir 400mg +/-lamivudine) until maximal ex vivo protection (against high or low titre of HIV-1BaL) was observed. (NCT03205566)
Timeframe: Up to 7 days from first dose

The Time to Cessation of Mucosal ex Vivo Protection From HIV After Stopping ART at Steady State.

Time in days from stopping antiretroviral (Raltegravir 400mg +/-lamivudine) until ex vivo protection (against high or low viral titre of HIV-1BaL) was no longer observed. (NCT03205566)
Timeframe: 5 days post last dose

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

Estradiol Concentration

Estradiol concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF

Total Testosterone

Total testosterone concentrations in blood plasma by LC-MS/MS (NCT04050371)
Timeframe: Baseline and after 4 weeks of daily FTC/TDF

CD4 Count Among HIV Infected Participants

CD4 cell count for HIV infected participants during the trial (NCT00458393)
Timeframe: at the time infection was detected

Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.

Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status. (NCT00458393)
Timeframe: At 24 weeks

Diagnosis of Gonorrhea During the Follow-up Period

Diagnosis of gonorrhea during the follow-up period by PCR (NCT00458393)
Timeframe: All of follow-up period, median of 1.2 years

Grade 1 or Higher Creatinine Toxicity

Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf (NCT00458393)
Timeframe: Duration of follow-up, median 1.2 years

Grade 2, 3, or 4 Clinical Adverse Events

Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf (NCT00458393)
Timeframe: Entire follow-up, median 1.2 years

Grade 2, 3, or 4 Laboratory Adverse Events

Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf (NCT00458393)
Timeframe: Entire follow-up, median 1.2 years

Grade 3 or Higher Phosphorous Toxicity

Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL) (NCT00458393)
Timeframe: The entire follow-up period, median 1.2 years

Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis

"A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to >5 fold upper limit of normal at any visit, or an increase to >2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.~More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/" (NCT00458393)
Timeframe: Quarterly lab tests through a median follow-up of 1.2 years

HIV Seroconversion

Confirmed HIV infection (NCT00458393)
Timeframe: Monthly follow-up through a median of 1.2 years

Incidence of Confirmed Syphilis During Follow-Up

Number of participants who have at least 1 confirmed syphilis infection during the study (NCT00458393)
Timeframe: All Follow-Up median of 1.2 years of follow-up

Incidence of HSV-2 During the Follow-up Period

Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline (NCT00458393)
Timeframe: Total study follow-up, a median of 1.2 years

Number of Condomless Sexual Partners With HIV Positive or Unknown Status

Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex (NCT00458393)
Timeframe: At 24 weeks

Percent Change in Total Cholesterol

Percent change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in fasting total cholesterol from baseline (NCT00458393)
Timeframe: Baseline and Week 24

Percentage Change in Body Fat

Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Body Fat from Baseline by dual-energy x-ray absorptiometry (NCT00458393)
Timeframe: Baseline and Week 24

Percentage Change in Fasting Triglycerides

Percentage Change (Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Triglycerides from Baseline from a fasting sample. (NCT00458393)
Timeframe: Baseline and Week 24

Percentage of Missed Doses by Estimate During CASI Interview

Percentage of missed doses by estimate during computer assisted structured interview (NCT00458393)
Timeframe: Week 24

Proportion of Missed Doses by Pill Count

Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles) (NCT00458393)
Timeframe: At 24 weeks

Total Number of Sexual Partners

Self-reported total number of sexual partners in the previous 12 weeks. (NCT00458393)
Timeframe: 24 weeks

Viral Load Among HIV Infected Participants

HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection (NCT00458393)
Timeframe: At the time closest to HIV detection

Among HIV Infected Participants Drug Resistance

Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period (NCT00458393)
Timeframe: at the time of HIV acquisition

Percentage Change in Bone Mineral Density

% Change from baseline in bone mineral density (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry (NCT00458393)
Timeframe: baseline and week 24.

Reviews

1 review available for adenine and Nausea

Trials

8 trials available for adenine and Nausea