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

Completed · Phase 4

Conditions studied: HIV Prevention

In brief

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)

Key facts

Study ID

NCT03499483

Run by

Fenway Community Health

People needed

52

Starts

2019-01-24

Expected to finish

2020-03-31

Last updated by the study team

2022-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• > Age of 18 at time of first visit.
• HIV uninfected
• Willing and able to provide written informed consent.
• Willing and able to provide adequate locator information.
• Willing and able to return to all study visits.
• Willing to participate in all study procedures.
• Childbearing age: Willing to use contraception for as long as they are on study medication plus 7 days after. (Appendix A: list of approved contraception).
• Possible sexual exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure. A possible exposure could include:
• Condomless anal, vaginal, oral, or mucosal (e.g. conjunctival) exposure to ejaculate from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage); or
• Condomless penile exposure to cervicovaginal secretions or anorectal secretions from a partner who is HIV-1 infected or high risk for HIV infection and of unknown HIV-1 serostatus (may include protected sexual exposure with condom failure, breakage or slippage)

You may not qualify if…

• An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.
• Pregnancy and/or breastfeeding.
• People who are actively trying to become pregnant.
• Acute or chronic hepatitis B infection.
• Acute or chronic renal disease.
• Creatinine clearance at or below 30 mL/min (Cockcroft-Gault0 Known intolerance or allergy to tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine, or bictegravir.
• Currently taking or plans to take prohibited medication while enrolled in the study. (Appendix B: complete list of prohibited medications).
• Non-English speakers.

Where it is running

• Fenway Community Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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