A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
Completed
- Conditions
- HIV
- Registration Number
- NCT01902472
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
Inclusion Criteria
- 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
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Exclusion Criteria
- This is an observational nested study and will monitor all reported seroconversions without intervention/exclusion.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication Baseline to Year 3 Proportion of seroconverters with resistance mutations Baseline to Year 3 Proportion of seroconverters with signs/symptoms at or before seroconversion Baseline to Year 3
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Gilead Sciences, Inc.
🇺🇸Foster City, California, United States