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

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ClinicalTrials.gov Identifier: NCT03499483
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health

Tracking Information
First Submitted Date  ICMJE April 9, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE January 24, 2019
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open Label single arm study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Prevention
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Open Label Biktarvy
Single arm all participants receive open label study product intervention.
Intervention: Drug: bictegravir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499483
Other Study ID Numbers  ICMJE 1141260-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kenneth H. Mayer, MD, Fenway Community Health
Study Sponsor  ICMJE Fenway Community Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth H Mayer, MD Fenway Health
PRS Account Fenway Community Health
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP