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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-02

Study Completion Date

2017-10-30

Brief Summary

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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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Detailed Description

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Conditions

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HIV

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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FTC/TDF for PrEP

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

No interventions assigned to this group

Eligibility Criteria

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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