A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)

Completed

Conditions studied: HIV

In brief

This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.

Key facts

Study ID

NCT01902472

Run by

Gilead Sciences

People needed

172

Starts

2013-09-02

Expected to finish

2017-10-30

Last updated by the study team

2020-07-14

Who can join

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

You may qualify if…

• Participant in a FTC/TDF PrEP demonstration project or FTC/TDF for PrEP clinical study
• HIV-1 negative adults (any sex/gender, including transgender) ≥ 18 years of age at time of enrollment in the demonstration project or clinical study.
• Evidence of seroconversion while receiving FTC/TDF for PrEP

You may not qualify if…

• This is an observational nested study and will monitor all reported seroconversions without intervention/exclusion.

Where it is running

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

Full record on ClinicalTrials.gov

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