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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01906255
First received: July 15, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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
HIV

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to onset of signs and/or symptoms of acute HIV infection before and after seroconversion during treatment [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
    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.

  • Time to seroconversion during during treatment [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
    The time to seroconversion in relation to exposure to study drug will be recorded.


Estimated Enrollment: 7000
Study Start Date: October 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 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 are participating in observational or clinical studies on 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

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.
  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: NCT01906255

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: NCT01906255     History of Changes
Other Study ID Numbers: GS-US-276-0104
Study First Received: July 15, 2013
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014