Clinical trial NCT01906255: Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Truvada® for HIV Pre-Exposure Prophylaxis (PrEP)
Official title: Adherence, HIV-1 Infection, Resistance, and Renal and Skeletal Adverse Event in Individuals Taking Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF, Truvada®) for HIV Pre-Exposure Prophylaxis (PrEP): A Pooled Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV-1
Truvada
FTC/TDF
Pre-exposure prophylaxis
PrEP
Adherence
Resistance
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-07-24
Enrollment: 10577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP
timeFrame: Baseline to Year 3
Secondary outcomes:
measure: Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment
timeFrame: Baseline to Year 3
measure: Time to seroconversion during treatment
timeFrame: Baseline to Year 3
Other outcomes:
Locations:
city: Foster City
country: United States
facility: Gilead Sciences, Inc.
state: California
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: