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

Gilead Sciences

Status: Completed

Conditions: HIV

Study type: Observational

Funder types: Industry

Identifiers

NCT01902472

EUPAS24374 (Registry Identifier)

GS-US-276-0103

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

172 participants in 1 patient group

FTC/TDF for PrEP

Description:

HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP