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
|Condition or disease||Intervention/treatment||Phase|
|HIV Prevention||Drug: bictegravir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label single arm study|
|Masking:||None (Open Label)|
|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|
Experimental: 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
- 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
- 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
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
|Contact: Marcy S Gelman, NP MPHfirstname.lastname@example.org|
|Contact: Amy Ben-Arieh, JD MPH||617-927-6031||ABen-Arieh@fenwayhealth.org|
|United States, Massachusetts|
|Fenway Community Health||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator: Kenneth Mayer, MPH|
|Principal Investigator:||Kenneth H Mayer, MD||Fenway Health|