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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01906255

Enrollment

10577

Registered

2013-07-24

Start date

2013-10-07

Completion date

2021-04-27

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

United States

Outcome results