Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2019 by Kenneth H. Mayer, MD, Fenway Community Health

Sponsor
Fenway Community Health


Information provided by (Responsible Party)
Kenneth H. Mayer, MD, Fenway Community Health

ClinicalTrials.gov Identifier
NCT03499483

First received: April 9, 2018
Last updated: April 4, 2019
Last Verified: April 2019
History of Changes
Purpose

Purpose

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)

Condition Intervention Phase
HIV Prevention

Drug : bictegravir
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description: Open Label single arm study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase IV Open-label Evaluation of Safety, Tolerability, and Acceptability of a Fixed-dose Formulation of Bictegravir, Emtricitabine/Tenofovir Alafenamide (B/F/TAF) for Non-occupational Prophylaxis Following Potential Exposure to HIV-1

Further study details as provided by Kenneth H. Mayer, MD, Fenway Community Health:

Primary Outcome Measures

  • nPEP Failure [ Time Frame: 4 months active study participation ]
    HIV sero-conversion during study participation following high risk exposure that occured within 72 hours of study product initiation.
  • Safety and Tolerability assessed as Adverse Events and Safety Lab Evaluation [ Time Frame: 4 months active study participation ]
    The following AEs will be evaluated: Diarrhea, Fatigue, Nausea/Vomiting, Headache, Dizziness, Body/Muscle/Joint pain
Secondary Outcome Measures:
  • Adherence and Acceptability assessed as study product completion rate [ Time Frame: 4 months of active study participation or 28 days of study product use ]
    Completion of Study Product as Prescribed; Stopped or Modified Study Product, Lost to Follow Up

Estimated Enrollment: 100
Study Start Date: January 24, 2019
Estimated Study Completion Date: September 1, 2021
Estimated Primary Completion Date: May 30, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Open Label Biktarvy
Single arm all participants receive open label study product intervention.
Drug: bictegravir

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

Other Name: emtricitabine/tenofovir alafenamide

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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

      contacts and locations

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: NCT03499483

      Contacts

      Contact:   Marcy S Gelman, NP MPH 617-927-6021 mgelman@fenwayhealth.org
      Contact:   Amy Ben-Arieh, JD MPH 617-927-6031 ABen-Arieh@fenwayhealth.org

      Locations

      United States, Massachusetts
      Fenway Community Health Recruiting
      Boston, Massachusetts, United States, 02215
      Principal Investigator: Kenneth Mayer, MPH

      Sponsors and Collaborators

      Fenway Community Health

      Investigators

      Principal Investigator: Kenneth H Mayer, MD Fenway Health
      More Information

      More Information


      Responsible Party: Kenneth H. Mayer, MD, Medical Research Director, Co-Chair TFI, Fenway Community Health  
      ClinicalTrials.gov Identifier: NCT03499483   History of Changes  
      Other Study ID Numbers: 1141260-1  
      Study First Received: April 9, 2018  
      Last Updated: April 4, 2019  
      Individual Participant Data    
      Plan to Share IPD: No  

      Studies a U.S. FDA-regulated Drug Product: Yes  
      Studies a U.S. FDA-regulated Device Product: No  
      Product Manufactured in and Exported from the U.S.: Yes  

      Keywords provided by Kenneth H. Mayer, MD, Fenway Community Health:

      Post-Exposure-Prophylaxis

      Additional relevant MeSH terms:
      Tenofovir
      Emtricitabine
      Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

      ClinicalTrials.gov processed this data on October 16, 2019
      This information is provided by ClinicalTrials.gov.