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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gilead Sciences, Inc.

Foster City, California, 94404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Jul 18, 2013
Registry last updated: Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed