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 August 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01902472
First received: July 15, 2013
Last updated: August 18, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 18, 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 August 26, 2014