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

Completed

• Conditions: HIV

• Registration Number: NCT01906255
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-24
• Study Start: 2013-10-07
• Primary Completion: 2021-04-27
• Study Completion: 2021-04-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10577

Inclusion Criteria

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP	Baseline to Year 3

Secondary Outcome Measures

Name	Time	Method
Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment	Baseline to Year 3	The time to onset of signs and/or symptoms if acute HIV infection in relation to exposure to study drug will be recorded. Signs and symptoms include fever, lymphadenopathy, pharyngitis, rash, myalgia, malaise, mouth and esophageal sores, and may also include, but less commonly, headache, nausea and vomiting, enlarged liver/spleen, weight loss, thrush, and neurological symptoms.
Time to seroconversion during treatment	Baseline to Year 3	The time to seroconversion in relation to exposure to study drug will be recorded.

Trial Locations

Locations (1)

Gilead Sciences, Inc.; 🇺🇸 Foster City, California, United States