adenine and AIDS Seroconversion

adenine has been researched along with AIDS Seroconversion in 65 studies

Research

Studies (65)

Authors

Clinical Trials (38)

Trial Overview

Trial Outcomes

Change From Baseline in CD4+ Cell Count at Week 24: Full Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment. (NCT03631732)
Timeframe: Baseline to Week 24

Change From Baseline in CD4+ Cell Count at Week 24: Week 24 Per Protocol Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment. (NCT03631732)
Timeframe: Baseline to Week 24

Change From Baseline in CD4+ Cell Count at Week 48: Full Analysis Set

The analysis includes values up to 1 day after permanent discontinuation of study treatment. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. (NCT03631732)
Timeframe: Baseline to Week 48

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A treatment-emergent adverse event was defined as any adverse event with onset date on or after the study treatment start date and no later than 30 days after the study drug stop date; or any adverse event leading to study drug discontinuation. (NCT03631732)
Timeframe: First B/F/TAF dose date up to Week 72 plus 30 days

Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Severity grades were defined by 'Gilead Grading Scale for Severity of AEs and Laboratory Abnormalities'. (NCT03631732)
Timeframe: First B/F/TAF dose date up to Week 72 plus 30 days

Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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. (NCT03631732)
Timeframe: Week 24

Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Week 24 Per Protocol Analysis Set

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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. (NCT03631732)
Timeframe: Week 24

Percentage of Participants Who Had HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. (NCT03631732)
Timeframe: Week 48

Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined 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. (NCT03631732)
Timeframe: Week 24

Percentage of Participants Who Had HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm: Full Analysis Set

The percentage of participants who had HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined 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. By Week 48, participants in B/F/TAF had received 48 weeks of treatment with B/F/TAF, while those in the Delayed B/F/TAF group had received only 24 weeks of treatment with B/F/TAF. (NCT03631732)
Timeframe: Week 48

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.

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

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

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

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

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

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

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

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

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

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

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

Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity

Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period. (NCT03302299)
Timeframe: Hepatotoxicity occurring during the six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.

Number of Participants Who Discontinued Treatment

Lack of tolerability will be defined as any isoniazid (INH) treatment discontinuation prior to completion of the prescribed course (6 months of INH taken over a maximum period of 9 months) due to side effects or alanine transaminase (ALT)/aspartate transaminase (AST) elevations. (NCT03302299)
Timeframe: Six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months.

Number of Participants With Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Elevations at Study Screening

Alanine transaminase (ALT) or aspartate transaminase (AST) elevations (>2x the upper limit of normal) at study screening (NCT03302299)
Timeframe: Study screening visit

Number of Participants With Latent Tuberculosis at Study Screening.

Latent tuberculosis assessed at screening via tuberculin skin testing (TST). A TST induration >=5mm was considered positive for latent tuberculosis. (NCT03302299)
Timeframe: Study screening visit

INH Concentration in Hair: (INH Pmol + Acetyl INH Pmol) Per mg of Hair

INH concentration in hair (pmol/mg) will be measured at 3- and 6- months during INH therapy. (NCT03302299)
Timeframe: Measured at 3- and 6- months after INH initiation

Percentage of Participants With Suboptimal INH Medication Adherence

Suboptimal INH adherence was defined as <90% of days with at least 1 electronic medication management (EMM) pill cap opening in the previous 90 days, at 3- and 6-months. (NCT03302299)
Timeframe: Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter)

Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days

"Participants were asked In the past 30 days, how many days in total have you not taken your pill? and were presented with a visual analog scale (VAS) to indicate the percentage of INH taken in the past 30 days. We converted the VAS percentage into number of days out of 30 to match the first question. Our final self-report measure was the minimum number of the 2 self-reported measurements." (NCT03302299)
Timeframe: Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH

Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale

The Self Rating Single Item (SRSI) adherence scale asks participants to rate their ability to take their medications as prescribed over the past 30 days. Participants reporting INH use in the prior 30 days at the 3- or 6-month interview are included here, and reported their INH adherence in the prior 30 days as excellent, very good, good, fair, poor, or very poor. (NCT03302299)
Timeframe: Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

CD4+ T-cell Count

CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks (NCT00625404)
Timeframe: Up to 16 weeks

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

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

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

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

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

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

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

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

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

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

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

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