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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906255
• Other study ID #: GS-US-276-0104
• Secondary ID: EUPAS24332
• Status: Completed
• Start date: October 7, 2013
• Est. completion date: April 27, 2021

Study information

• Verified date: August 2021
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10577
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Infection

Locations

Country	Name	City	State
United States	Gilead Sciences, Inc.	Foster City	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP		Baseline to Year 3
Secondary	Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment	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.	Baseline to Year 3
Secondary	Time to seroconversion during treatment	The time to seroconversion in relation to exposure to study drug will be recorded.	Baseline to Year 3