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

This study is currently recruiting participants.
Verified November 2017 by Gilead Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01902472
First Posted: July 18, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
July 15, 2013
July 18, 2013
November 6, 2017
September 2, 2013
September 2019   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01902472 on ClinicalTrials.gov Archive Site
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A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
One hundred fifty (150) HIV-1 negative adults (any sex/gender, including transgender) and ≥ 18 years of age who seroconvert while taking FTC/TDF for PrEP.
HIV
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
September 2019
September 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Lindsey Smith Lindsey.Smith@gilead.com
United States
 
 
NCT01902472
GS-US-276-0103
No
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Gilead Sciences
Gilead Sciences
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Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
November 2017