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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01902472
First received: July 15, 2013
Last updated: July 17, 2014
Last verified: July 2014

July 15, 2013
July 17, 2014
September 2013
January 2016   (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 ] [ Designated as safety issue: No ]
  • Proportion of seroconverters with resistance mutations [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
  • Proportion of seroconverters with signs/symptoms at or before seroconversion [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01902472 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2016
January 2016   (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.
Both
18 Years and older
No
Contact: Rebecca Guzman rebecca.guzman@gilead.com
United States
 
NCT01902472
GS-US-276-0103
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Keith Rawlings, MD Gilead Sciences
Gilead Sciences
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP