NCT07476339 REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE
| NCT ID | NCT07476339 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | CAN Community Health |
| Condition | HIV -1 Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2027-06-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2026-06-17 with a primary completion date of 2027-06-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * ≥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 Exclusion Criteria: * 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
Contact & Investigator
Jessica Altamirano, MD
PRINCIPAL INVESTIGATOR
CAN Community Health
Frequently Asked Questions
Who can join the NCT07476339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV -1 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07476339 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07476339 currently recruiting?
Yes, NCT07476339 is actively recruiting participants. Contact the research team at pshukla@cancommunityhealth.org for enrollment information.
Where is the NCT07476339 trial being conducted?
This trial is being conducted at Clearwater, United States, Ft. Pierce, United States, Jacksonville, United States, Orlando, United States and 6 additional locations.
Who is sponsoring the NCT07476339 clinical trial?
NCT07476339 is sponsored by CAN Community Health. The principal investigator is Jessica Altamirano, MD at CAN Community Health. The trial plans to enroll 200 participants.
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