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NCT01902472 Clinical Trial

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

HIV Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01902472
Other study ID # GS-US-276-0103
Secondary ID EUPAS24374
Status Completed
Phase
First received
Last updated
Start date September 2, 2013
Est. completion date October 30, 2017

Study information
Verified date July 2020
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 172
Est. completion date October 30, 2017
Est. primary completion date October 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Gilead Sciences, Inc. Foster City California

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication Baseline to Year 3
Primary Proportion of seroconverters with resistance mutations Baseline to Year 3
Primary Proportion of seroconverters with signs/symptoms at or before seroconversion Baseline to Year 3
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