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

Completed

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT01906255

Run by

Gilead Sciences

People needed

10577

Starts

2013-10-07

Expected to finish

2021-04-27

Last updated by the study team

2021-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Gilead Sciences, Inc. — Foster City, California, United States

Full record on ClinicalTrials.gov

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