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

N/ACompletedNCT01902472

Gilead Sciences172 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

172

Conditions

HIV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Gilead Sciences, Inc.

Foster City, California, United States

Outcomes

Primary Outcomes

Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication

Time frame: Baseline to Year 3

Proportion of seroconverters with resistance mutations

Time frame: Baseline to Year 3

Proportion of seroconverters with signs/symptoms at or before seroconversion

Time frame: Baseline to Year 3

Data from ClinicalTrials.gov

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