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

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ClinicalTrials.gov Identifier: NCT01902472
Recruitment Status : Recruiting
First Posted : July 18, 2013
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
HIV

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
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)
Actual Study Start Date : September 2, 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP


Outcome Measures

Primary Outcome Measures :
  1. Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication [ Time Frame: Baseline to Year 3 ]
  2. Proportion of seroconverters with resistance mutations [ Time Frame: Baseline to Year 3 ]
  3. Proportion of seroconverters with signs/symptoms at or before seroconversion [ Time Frame: Baseline to Year 3 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902472


Contacts
Contact: Lindsey Smith Lindsey.Smith@gilead.com

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

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01902472     History of Changes
Other Study ID Numbers: GS-US-276-0103
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents