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Seroconversions, Resistance, Adverse Events and Drug Adherence Among Subjects Taking Truvada® for PrEP: A Case Control Study

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ClinicalTrials.gov Identifier: NCT01906255
Recruitment Status : Recruiting
First Posted : July 24, 2013
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

This is an observational nested case control study among pre-exposure prophylaxis (PrEP) observational or clinical studies. The study will assess level of adherence as measured by drug level and its relationship to renal and bone adverse events, risk of seroconversion, and resistance development in subjects taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for PrEP.

In the protocols of the parent PrEP observational or clinical studies, participants will have follow-up visits on average every 3 months for evaluation of adherence, HIV-1 status, renal and bone adverse events, and seroconversion. Adherence will be determined by the specific FTC/TDF drug level measurement(s) outlined in the parent protocol.

There are two case definitions: a) One-hundred-fifty subjects who seroconvert (become HIV-1 positive) and b) any subjects who either develop a protocol-defined renal adverse event (stratified by Division of AIDS [DAIDS] grading) or have a skeletal adverse event (any fracture) while taking FTC/TDF for PrEP.

Among the estimated 7,000 subjects from Truvada for PrEP observational and clinical studies all cases, defined as subjects who seroconvert and/or develop either renal or skeletal adverse events, will be identified. Randomly chosen controls on Truvada will be selected in a 3:1 ratio, from the same site, with a similar treatment duration.


Condition or disease
HIV

Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Seroconversions, Resistance, Adverse Events and Drug Adherence Among Subjects Taking Truvada® for PrEP: A Case Control Study
Actual Study Start Date : October 7, 2013
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Group/Cohort
FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender) who are participating in observational or clinical studies on FTC/TDF for PrEP



Primary Outcome Measures :
  1. Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP [ Time Frame: Baseline to Year 3 ]

Secondary Outcome Measures :
  1. Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment [ Time Frame: Baseline to Year 3 ]
    The time to onset of signs and/or symptoms if acute HIV infection in relation to exposure to study drug will be recorded. Signs and symptoms include fever, lymphadenopathy, pharyngitis, rash, myalgia, malaise, mouth and esophageal sores, and may also include, but less commonly, headache, nausea and vomiting, enlarged liver/spleen, weight loss, thrush, and neurological symptoms.

  2. Time to seroconversion during during treatment [ Time Frame: Baseline to Year 3 ]
    The time to seroconversion in relation to exposure to study drug will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Seven thousand (7000) HIV-1 negative adults (any sex/gender, including transgender) who are participating in observational or clinical studies on FTC/TDF for PrEP
Criteria

Inclusion Criteria:

  • Participants in an FTC/TDF for PrEP observational or clinical study
  • HIV-1 negative adults (any sex/gender, including transgender) in an FTC/TDF for PrEP observational or clinical study
  • HIV-1 negative and without signs or symptoms of acute HIV-1 infection

Exclusion Criteria:

  • This is an observational study and will monitor all reported seroconversions, and renal or skeletal adverse events without intervention/exclusion.

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): NCT01906255


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

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01906255     History of Changes
Other Study ID Numbers: GS-US-276-0104
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

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