Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)
Verified April 2019 by Kenneth H. Mayer, MD, Fenway Community Health
Fenway Community Health
Information provided by (Responsible Party)
Kenneth H. Mayer, MD, Fenway Community Health
First received: April 9, 2018
Last updated: April 4, 2019
Last Verified: April 2019
History of Changes
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)
Drug : bictegravir
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
[ 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
- 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
|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)|
Open Label Biktarvy
Single arm all participants receive open label study product intervention.
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
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
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- > 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
- 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)
- 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.
Contacts and LocationsChoosing 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
|Contact: Marcy S Gelman, NP MPHfirstname.lastname@example.org|
|Contact: Amy Ben-Arieh, JD MPH||617-927-6031||ABen-Arieh@fenwayhealth.org|
Locations Show More
|United States, Massachusetts|
|Fenway Community Health||Recruiting|
|Boston, Massachusetts, United States, 02215|
Principal Investigator: Kenneth Mayer, MPH
Sponsors and CollaboratorsFenway Community Health
|Principal Investigator:||Kenneth H Mayer, MD||Fenway Health|
|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:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
ClinicalTrials.gov processed this data on August 16, 2019
This information is provided by ClinicalTrials.gov.