REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE

Recruiting now · Phase 4

Conditions studied: HIV -1 Infection, HIV (Human Immunodeficiency Virus), HIV, HIV 1 Infection

In brief

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.

Key facts

Study ID: NCT07476339
Run by: CAN Community Health
People needed: 200
Starts: 2026-06-17
Expected to finish: 2027-06-17
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥18 years of age at the time of signing the informed consent form (ICF)
Diagnosis of HIV-1 confirmed by any positive HIV 4th generation test or detectable HIV-1 RNA level in >6 months
Previously received ART for ≥30 consecutive days, as self-reported
No ART dose received for ≥12 weeks prior to provision of informed consent, by any route of administration (i.e., injection or oral), as self-reported
Returning to care with an interest to restart ART therapy
Body weight ≥55.12lbs (25 kg)
Signed ICF as described in the protocol which includes compliance with the requirements and restrictions listed in ICF and study protocol

You may not qualify if…

Diagnosis of HIV-2 infection
Known or suspected history of severe hepatic impairment (Child-Pugh Class C)
Known or suspected history of severe renal impairment (estimated creatinine clearance [eCrCl] <30 mL/min)
Concomitant medication that is contraindicated with B/F/TAF
Known or suspected resistance to BIC (resistance-associated mutations [RAMs] include: G118R, Y143C/H/R, Q148H/K/R, N155H/S, or R263K in the integrase gene)
Known/suspected resistance to tenofovir (TFV) (RAMs include: K65R/E/N, or K70E)
Known/suspected history of 3 or more thymidine analog mutation (TAMs) (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in reverse transcriptase (RT)
History of B/F/TAF intolerance
Unable to swallow whole tablets or swallow tablets cut into halves
Unable to communicate in either English or Spanish

Where it is running

CAN Community Health — Las Vegas, Nevada, United States (enrolling)
Midway Specialty Care Center — Ft. Pierce, Florida, United States (enrolling)
CAN Community Health — Jacksonville, Florida, United States (enrolling)
CAN Community Health — Orlando, Florida, United States (enrolling)
Midway Specialty Care Center — West Palm Beach, Florida, United States (enrolling)
CAN Community Health — Clearwater, Florida, United States (enrolling)
CAN Community Health — Tampa, Florida, United States (enrolling)
Midway Specialty Care Center — Temple Terrace, Florida, United States (enrolling)
Midway Specialty Care Center — Orlando, Florida, United States
Midway Specialty Care Center — Wilton Manors, Florida, United States

Full record on ClinicalTrials.gov

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