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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499483
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kenneth H. Mayer, MD, Fenway Community Health

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)

Condition or disease Intervention/treatment Phase
HIV Prevention Drug: bictegravir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
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
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499483


Contacts
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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
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United States, Massachusetts
Fenway Community Health Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Kenneth Mayer, MPH         
Sponsors and Collaborators
Fenway Community Health
Investigators
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Principal Investigator: Kenneth H Mayer, MD Fenway Health
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Responsible Party: Kenneth H. Mayer, MD, Medical Research Director, Co-Chair TFI, Fenway Community Health
ClinicalTrials.gov Identifier: NCT03499483    
Other Study ID Numbers: 1141260-1
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents