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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
  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 ]
  • 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 ]

Estimated Enrollment: 150
Actual Study Start Date: September 2, 2013
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (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

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 Submitted: July 15, 2013
First Posted: July 18, 2013
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