Study will evaluate the safety and tolerability of once daily Biktarvy for 28 days for prevention of HIV infection in HIV-1-seronegative adults after high-risk sexual contact. (non-occupational post exposure prophylaxis - nPEP)
Non-randomized, open label single arm trial conducted at Fenway Health as a single site. 100 subjects will be enrolled following a high risk sexual exposure in which HIV exposure is a concern. Each person will be provided with detailed informed consent and if they agree, will receive a 28 day regimen of BIC/F/TAF (Biktary) in a single fixed-dose tablet. Subjects will be seen for 3 visits over a period of four months in which assessments will be done to evaluate safety of product, tolerability of product and HIV status. All subjects will be compared to historical controls in the previous one daily TDF-based nPEP studies which were conducted at Fenway Health.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
52
Single One Pill Formulation of bictegravir, emtricitabine/tenofovir alafenamide (Bictarvy) to be taken once daily orally for a period of 28 days.
Fenway Community Health
Boston, Massachusetts, United States
nPEP Failure
HIV sero-conversion during study participation following high risk exposure that occured within 72 hours of study product initiation.
Time frame: 4 months active study participation
Safety and Tolerability assessed as Adverse Events and Safety Lab Evaluation
The following AEs will be evaluated: Diarrhea, Fatigue, Nausea/Vomiting, Headache, Dizziness, Body/Muscle/Joint pain
Time frame: 4 months active study participation
Adherence and Acceptability assessed as study product completion rate
Completion of Study Product as Prescribed; Stopped or Modified Study Product, Lost to Follow Up
Time frame: 4 months of active study participation or 28 days of study product use
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