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

NCT07476339 | Not Yet Recruiting Phase 4 FDA Drug

• 3 other identifiers: CAN-MID-REINITIATE-01CO-US-380-7671CO-US-380-7672
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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

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

Outcome Measures

Primary Outcomes (2)

• Percentage of participants in Cohort 1 with plasma HIV-1 RNA <50 copies/mL

  Percentage of all participants who have plasma HIV-1 RNA Viral Load \<50 c/mL at W24 using FDA snapshot analysis, which defines a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation

  Week 24

• Percentage of participants in Cohort 2 with plasma HIV-1 RNA ≥50 copies/mL

  Percentage of all participants who have plasma HIV-1 RNA Viral Load ≥50 c/mL at W24 using FDA snapshot analysis, which defines a participant's virologic response status using only the viral load at the predefined timepoint within a certain window of time, along with study drug discontinuation

  Week 24

Secondary Outcomes (22)

• Percentage of participants with plasma HIV-1 RNA <50 copies/mL

  48 weeks

• Percentage of participants with plasma HIV-1 RNA <200 copies/mL

  48 weeks

• Percentage of participants meeting protocol-defined virologic failure (PDVF) criteria in Cohort 1

  48 weeks

• Percentage of participants meeting PDVF criteria in Cohort 2

  24 weeks

• Absolute and change from baseline in log10 HIV-1 RNA viral load of participants

  48 weeks

Study Arms (1)

Open-label B/F/TAF

EXPERIMENTAL

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.

Drug: Bictegravir, emtricitabine, and tenofovir alafenamide

Interventions

Bictegravir, emtricitabine, and tenofovir alafenamide DRUG

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.

Also known as: B/F/TAF, BIKTARVY®

Open-label B/F/TAF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 ≥25 kg
• Signed ICF 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: T66A/I/K, E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene)
• Known/suspected resistance to TFV (RAMs include: K65R/E/N, or K70E)
• Known/suspected history of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in 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

Sponsors & Collaborators

• CAN Community Health: lead
• Gilead Sciences: collaborator
• Midway Specialty Care Center: collaborator
• Costello Medical Inc.: collaborator

Study Sites (10)

CAN Community Health

Clearwater, Florida, 33765, United States

Location

Midway Specialty Care Center

Ft. Pierce, Florida, 34982, United States

Location

CAN Community Health

Jacksonville, Florida, 32207, United States

Location

CAN Community Health

Orlando, Florida, 32804, United States

Location

Midway Specialty Care Center

Orlando, Florida, 32819, United States

Location

CAN Community Health

Tampa, Florida, 33602, United States

Location

Midway Specialty Care Center

Temple Terrace, Florida, 33617, United States

Location

Midway Specialty Care Center

West Palm Beach, Florida, 33409, United States

Location

Midway Specialty Care Center

Wilton Manors, Florida, 33334, United States

Location

CAN Community Health

Las Vegas, Nevada, 89104, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jessica Altamirano, MD

  CAN Community Health

  PRINCIPAL INVESTIGATOR

• Hector Bolivar, MD

  Midway Specialty Care Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prerak Shukla, MD

CONTACT

941-366-0134; pshukla@cancommunityhealth.org

Miranda Townsend

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, non-randomized study without a control group. The rapid restart nature of this study involves the concurrent initiation of screening, baseline assessments, and administration of B/F/TAF on the same day. The study treatment commences without all baseline test results being available, provided the participant fulfills all eligibility criteria. All eligible participants commence on the same oral, once-daily, fixed-dose combination of B/F/TAF which is a single-tablet regimen of 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). Once baseline assessment of viral load results are available participants are allocated into the relevant cohort which defines the duration of their study intervention. Cohort 1 (48 week follow up) will include viremic participants (HIV-1 RNA ≥50 copies/mL) at baseline and Cohort 2 (24 week follow up) will include virologically suppressed participants (HIV-1 RNA \<50 copies/mL) at baseline.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)