Bictegravir + Emtricitabine + Tenofovir Alafenamide for HIV
(REINITIATE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.
The REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B/F/TAF on the same day that they return to care. B/F/TAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.
Researchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.
Who Is on the Research Team?
Jessica Altamirano, MD
Principal Investigator
CAN Community Health
Hector Bolivar, MD
Principal Investigator
Midway Specialty Care Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive open-label B/F/TAF for either 24 or 48 weeks depending on baseline viral load
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Interviews
Semi-structured interviews conducted to understand participant experiences
What Are the Treatments Tested in This Trial?
Interventions
- Bictegravir, emtricitabine, and tenofovir alafenamide
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All participants receive open-label B/F/TAF. Treatment duration is determined by baseline viral load: viremic participants (defined by HIV-1 RNA ≥50 copies/mL) at baseline will receive 48 weeks of B/F/TAF; virologically suppressed participants (defined by HIV-1 RNA \<50 copies/mL) at baseline will receive 24 weeks of B/F/TAF.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CAN Community Health
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Midway Specialty Care Center
Collaborator
Costello Medical Inc.
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.