HIV
Conditions
Keywords
HIV-1, Truvada, FTC/TDF, Pre-exposure prophylaxis, PrEP, Resistance
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.
Interventions
None listed
Sponsors
Gilead Sciences
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Exclusion criteria
* This is an observational nested study and will monitor all reported seroconversions without intervention/exclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed