Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)

NCT01906255 | Completed

• 2 other identifiers: GS-US-276-0104EUPAS24332
• Study Type: observational
• Target: 10,577
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study of HIV-1 negative individuals who participated in demonstration projects or clinical studies and took daily Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for pre-exposure prophylaxis (PrEP). All individuals were enrolled and followed as described in the parent PrEP demonstration project or clinical study protocol until study completion, HIV-1 infection, discontinuation due to an adverse event, lost to follow-up, or administrative censoring. In the protocols of the parent PrEP observational or clinical studies, participants had follow-up visits on average every 3 months for evaluation of adherence, renal and bone adverse events, and HIV-1 infection status. Adherence was determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol. Gilead had collected data from 21 global PrEP demonstration projects and clinical studies for over 7,000 Truvada for PrEP users who had at least one measurement of adherence. Data from the different contributing studies were pooled for statistical analyses by Gilead.

Conditions

HIV

Keywords

HIV-1; Truvada; FTC/TDF; Pre-exposure prophylaxis; PrEP; Adherence; Resistance

Outcome Measures

Primary Outcomes (1)

• Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP

  Baseline to Year 3

Secondary Outcomes (2)

• Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment

  Baseline to Year 3

• Time to seroconversion during treatment

  Baseline to Year 3

Study Arms (1)

FTC/TDF for PrEP

HIV-1 negative adults (any sex/gender, including transgender, pregnancy) who are participating in observational or clinical studies on FTC/TDF for PrEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Seven thousand (7000) HIV-1 negative adults (any sex/gender, including transgender, pregnancy) who are participating in observational or clinical studies on FTC/TDF for PrEP

You may qualify if:

• Participants in an FTC/TDF for PrEP observational or clinical study
• HIV-1 negative individual at the time of enrollment in a demonstration project or clinical study
• Participants with at least one measurement of tenofovir-diphosphate (TFV-DP) in dried blood spot (DBS) or tenofovir (TFV) in plasma

You may not qualify if:

• This is an observational study and will collect HIV-1 infection and resistance information along with renal or skeletal adverse events without intervention.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences, Inc.

Foster City, California, 94404, United States

Location

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 24, 2013
• Study Start: October 7, 2013
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)