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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 October 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01906255
First received: July 15, 2013
Last updated: October 31, 2014
Last verified: October 2014

July 15, 2013
October 31, 2014
October 2013
February 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01906255 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Seroconversions, Resistance, Adverse Events and Drug Adherence Among Subjects Taking Truvada® for PrEP: A Case Control Study
Seroconversions, Resistance, Adverse Events and Drug Adherence Among Subjects Taking Truvada® for PrEP: A Case Control Study

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

HIV
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
7000
February 2016
February 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Rebecca Guzman rebecca.guzman@gilead.com
United States
 
NCT01906255
GS-US-276-0104
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Keith Rawlings, MD Gilead Sciences
Gilead Sciences
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP