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

NCT ID: NCT03499483

Last Updated: 2022-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-24
• Study Completion Date: 2020-03-31

Brief 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)

Detailed 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.

Conditions

HIV Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Open Label Biktarvy

Single arm all participants receive open label study product intervention.

Group Type: EXPERIMENTAL

bictegravir

Intervention Type: DRUG

Single One Pill Formulation of bictegravir, emtricitabine/tenofovir alafenamide (Bictarvy) to be taken once daily orally for a period of 28 days.

Interventions

bictegravir

Single One Pill Formulation of bictegravir, emtricitabine/tenofovir alafenamide (Bictarvy) to be taken once daily orally for a period of 28 days.

Intervention Type: DRUG

Other Intervention Names

emtricitabine/tenofovir alafenamide

Eligibility Criteria

Inclusion Criteria

1. > Age of 18 at time of first visit.

2. HIV uninfected

3. Willing and able to provide written informed consent.

4. Willing and able to provide adequate locator information.

5. Willing and able to return to all study visits.

6. Willing to participate in all study procedures.

7. 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).

8. 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:

1. 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

2. 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)

Exclusion Criteria

1. An active psychiatric illness or active drug or alcohol abuse that, in the opinion of the investigator, could prevent compliance with study procedures.

2. Pregnancy and/or breastfeeding.

3. People who are actively trying to become pregnant.

4. Acute or chronic hepatitis B infection.

5. Acute or chronic renal disease.

6. Creatinine clearance at or below 30 mL/min (Cockcroft-Gault0 Known intolerance or allergy to tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine, or bictegravir.

8. Currently taking or plans to take prohibited medication while enrolled in the study. (Appendix B: complete list of prohibited medications).

9. Non-English speakers.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fenway Community Health

OTHER

Sponsor Role: lead

Responsible Party

Kenneth H. Mayer, MD

Medical Research Director, Co-Chair TFI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth H Mayer, MD

Role: PRINCIPAL_INVESTIGATOR

Fenway Health

Locations

Fenway Community Health

Boston, Massachusetts, United States

Countries

United States

References

Mayer KH, Gelman M, Holmes J, Kraft J, Melbourne K, Mimiaga MJ. Safety and Tolerability of Once Daily Coformulated Bictegravir, Emtricitabine, and Tenofovir Alafenamide for Postexposure Prophylaxis After Sexual Exposure. J Acquir Immune Defic Syndr. 2022 May 1;90(1):27-32. doi: 10.1097/QAI.0000000000002912.

Reference Type: DERIVED

PMID: 34991141 (View on PubMed)

Other Identifiers

1141260-1

Identifier Type: -

Identifier Source: org_study_id