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

NCT03499483 | Completed Phase 4 FDA Drug

• 1 other identifier: 1141260-1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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)

Conditions

HIV Prevention

Keywords

Post-Exposure-Prophylaxis

Outcome Measures

Primary Outcomes (2)

• nPEP Failure

  HIV sero-conversion during study participation following high risk exposure that occured within 72 hours of study product initiation.

  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

  4 months active study participation

Secondary Outcomes (1)

• Adherence and Acceptability assessed as study product completion rate

  4 months of active study participation or 28 days of study product use

Study Arms (1)

Open Label Biktarvy

EXPERIMENTAL

Single arm all participants receive open label study product intervention.

Drug: bictegravir

Interventions

bictegravir DRUG

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

Also known as: emtricitabine/tenofovir alafenamide

Open Label Biktarvy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fenway Community Health: lead

Study Sites (1)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 34991141 DERIVED

MeSH Terms

Interventions

bictegravir; emtricitabine tenofovir alafenamide

Study Officials

• Kenneth H Mayer, MD

  Fenway Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Research Director, Co-Chair TFI

Model Details: Open Label single arm study

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: January 24, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 31, 2020
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)