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

This study is currently recruiting participants.
Verified April 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01902472
First received: July 15, 2013
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition
HIV

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: September 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01902472

Contacts
Contact: Rebecca Guzman rebecca.guzman@gilead.com

Locations
United States, California
Gilead Sciences, Inc. Recruiting
Foster City, California, United States, 94404
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Keith Rawlings, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01902472     History of Changes
Other Study ID Numbers: GS-US-276-0103
Study First Received: July 15, 2013
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HIV-1
Truvada
FTC/TDF
Pre-exposure prophylaxy
PrEP
Resistance

ClinicalTrials.gov processed this record on April 16, 2014