Recruiting

B/F/TAF

Sponsor:

CAN Community Health

Code:

NCT07476339

Conditions

HIV -1 Infection

HIV (Human Immunodeficiency Virus)

HIV

HIV 1 Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bictegravir, emtricitabine, and tenofovir alafenamide

Study Details

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.

Conditions

HIV -1 Infection

HIV (Human Immunodeficiency Virus)

HIV

HIV 1 Infection

Study ID

NCT07476339

Start date

Jun 17, 2026

Status verified date

Sep, 2026

Completion date

Jun 17, 2027

Anticipated

Primary completion date

Jun 17, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open-label B/F/TAF

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.

Interventions

Bictegravir, emtricitabine, and tenofovir alafenamide

Oral, film-coated tablet containing 50 mg BIC, 200 mg FTC, and 25 mg TAF taken once daily with or without food administered for 24 or 48 weeks.

Primary outcome measure

  • Percentage of participants in Cohort 1 with plasma HIV-1 RNA <50 copies/mL [ Time Frame: Week 24 ]
  • Percentage of participants in Cohort 2 with plasma HIV-1 RNA ≥50 copies/mL [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Prerak Shukla, MD

941-366-0134pshukla@cancommunityhealth.org

Miranda Townsend

+44 7709-514-696biktarvy.rapidrestartstudy@costellomedical.com

Locations

CAN Community Health

Recruiting

Clearwater, Florida, United States, 33765

Contacts

Jessica Altamirano, MD

786-800-5631jaltamirano@cancommunityhealth.org

Jeanette Cancel, MD

727-216-6193jcancel@cancommunityhealth.org

Midway Specialty Care Center

Recruiting

Ft. Pierce, Florida, United States, 34982

Contacts

Hector Bolivar, MD

561-249-2279drbolivar@midwaycare.org

Jenn L Kuretski, DNP, APRN, NP-C,AAHIVS

772-464-9746Jkuretski@midwaycare.org

CAN Community Health

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Jessica Altamirano, MD

786-800-5631jaltamirano@cancommunityhealth.org

Katherine Rogers, APRN

904-508-0701krogers@cancommunityhealth.org

CAN Community Health

Recruiting

Orlando, Florida, United States, 32804

Contacts

Jessica Altamirano, MD

786-800-5631jaltamirano@cancommunityhealth.org

Vincenzo Scotto D'Antuono, MD

407-246-1946vsdantuono@cancommunityhealth.org

Midway Specialty Care Center

Recruiting

Orlando, Florida, United States, 32819

Contacts

Hector Bolivar, MD

561-249-2279drbolivar@midwaycare.org

Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS

407-745-1171Jkuretski@midwaycare.org

CAN Community Health

Recruiting

Tampa, Florida, United States, 33602

Contacts

Jessica Altamirano, MD

786-800-5631jaltamirano@cancommunityhealth.org

Elier Rodriguez, MD

941-300-4440erodriguez@cancommunityhealth.org

Midway Specialty Care Center

Recruiting

Temple Terrace, Florida, United States, 33617

Contacts

Hector Bolivar, MD

561-249-2279drbolivar@midwaycare.org

Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS

813-733-8224Jkuretski@midwaycare.org

Midway Specialty Care Center

Recruiting

West Palm Beach, Florida, United States, 33409

Contacts

Hector Bolivar, MD

561-249-2279drbolivar@midwaycare.org

Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS

561-249-2279Jkuretski@midwaycare.org

Midway Specialty Care Center

Recruiting

Wilton Manors, Florida, United States, 33334

Contacts

Hector Bolivar, MD

561-249-2279drbolivar@midwaycare.org

Jenn L Kuretski, DNP, APRN, NP-C, AAHIVS

954-530-8357Jkuretski@midwaycare.org

CAN Community Health

Recruiting

Las Vegas, Nevada, United States, 89104

Contacts

Jessica Altamirano, MD

786-800-5631jaltamirano@cancommunityhealth.org

Archer Grimley, MD

702-979-1111archgrimley@cancommunityhealth.org

More Information

Sponsor

CAN Community Health

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • HIV-1
  • HIV Infections
  • Bictegravir
  • Emtricitabine
  • Tenofovir Alafenamide
  • Antiretroviral Therapy
  • Antiretroviral Therapy, Highly Active
  • Treatment Interruption
  • Virologically Suppressed
  • Treatment-Experienced
  • Returning to Care
  • Phase 4
  • B/F/TAF
  • B/F/TAF; bictegravir, emtricitabine, tenofovir alafenamide, drug combination
  • Rapid Restart

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CAN Community Health on 2026-09-03.