Restarting HIV treatment with a single-pill regimen (B/F/TAF) after a treatment gap

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, single-arm phase 4 study evaluating rapid reinitiation of antiretroviral therapy using the once-daily fixed-dose combination bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in adults with HIV who have been off ART for 12 weeks or more. Participants begin screening, baseline assessments, and treatment on the same day to minimize delays in reengaging care. The study collects data on treatment effectiveness and safety in routine clinical settings and also documents reasons for prior interruptions and for restarting ART. B/F/TAF is presented as the guideline-recommended single-tablet regimen suitable for rapid restart, including use in diverse populations.

Why it matters

Who can join: the full rules

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

Where it's running

• CAN Community Health
  Clearwater, Florida, United States Recruiting
• Midway Specialty Care Center
  Ft. Pierce, Florida, United States Recruiting
• CAN Community Health
  Jacksonville, Florida, United States Recruiting
• CAN Community Health
  Orlando, Florida, United States Recruiting
• Midway Specialty Care Center
  Orlando, Florida, United States Recruiting
• CAN Community Health
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Jessica Altamirano, MD — CAN Community Health
• Study coordinator: Prerak Shukla, MD
• Email: pshukla@cancommunityhealth.org
• Phone: 941-366-0134

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reexamining how asymptomatic tuberculosis spreads

  This project will test whether people with asymptomatic tuberculosis—particularly adults living with HIV—can pass TB to their household and close contacts.

  Recruiting Barcelona Institute for Global Health · Manhiça, Maputo Province · NCT07312266

• ICONA Prevention Program for People Using PrEP in Italy

  This program will follow HIV-negative adults in Italy who are starting or already using PrEP to see how well PrEP prevents HIV, how tolerable it is, and what helps or hinders people from staying on it.

  Recruiting at 18 sites Fondazione ICONA · Chieti, Abruzzo and 52 other locations · NCT07186244

• Pregnant Women Living with HIV on Bictegravir/Emtricitabine/Tenofovir Alafenamide

  This study looks at how B/F/TAF is used in pregnant women with HIV and whether it helps maintain viral suppression from before conception through delivery.

  Recruiting Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Paris · NCT07921472

• Multiple interventions to try for HIV remission in people on ART

  This study tests a combination approach, including intensified ART, latency-reversal agents, and autologous dendritic cell therapy, to see if people living with HIV on long-term ART can achieve sustained viral suppression or prolonged remission.

  Recruiting Phase 2 Federal University of São Paulo · São Paulo, São Paulo · NCT07903441

• Weekly long-acting HIV-1 meds switch for people with undetectable virus

  This study tests whether switching to weekly oral long-acting HIV medicines works as well as staying on current daily pills for people with HIV who already have an undetectable viral load.

  Recruiting at 2 sites Phase 2 Gilead Sciences · Ft. Pierce, Florida and 1 other locations · NCT07841990

• Project SHIELD 2.0: Police Education to Support Public Health in Kentucky

  Aimed at police in Kentucky, this program tests whether SHIELD training given to officers, with health workers helping deliver it, can reduce drug-related arrests and steer people who use drugs toward MOUD and other health services.

  Recruiting Johns Hopkins Bloomberg School of Public Health · Lexington, Kentucky · NCT07804121

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.