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.
|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|
- Treatment adherence, as measured by drug level, to the once-daily dosing regimen of FTC/TDF for PrEP [ Time Frame: Baseline to Year 3 ]
- 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.
- 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.
|Actual Study Start Date:||October 7, 2013|
|Estimated Study Completion Date:||April 2020|
|Estimated Primary Completion Date:||April 2020 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01906255
|Contact: Lindsey Smith||Lindsey.Smith@gilead.com|
|United States, California|
|Gilead Sciences, Inc.||Recruiting|
|Foster City, California, United States, 94404|
|Study Director:||Gilead Study Director||Gilead Sciences|