Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)

Status Completed

Clinical Trial Summary

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)

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

HIV Prevention

Clinical Trial Details

NCT number	NCT03499483
Study type	Interventional
Source	Fenway Community Health
Contact
Status	Completed
Phase	Phase 4
Start date	January 24, 2019
Completion date	March 31, 2020

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