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Can a Same-Day HIV pill restart help patients get back on track?

NCT ID NCT07476339

Disease control Sponsor: CAN Community Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study looks at whether people with HIV who have stopped their medication for at least 12 weeks can safely restart treatment with a single daily pill (B/F/TAF) on the same day they return to care. About 200 adults will take part to see if this quick restart helps lower the virus and keeps them engaged in treatment. The goal is to make it easier for patients to get back on therapy and control HIV.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV HIV (human immunodeficiency virus) HIV-1-infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CAN Community Health

    RECRUITING

    Clearwater, Florida, 33765, United States

  • CAN Community Health

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • CAN Community Health

    RECRUITING

    Orlando, Florida, 32804, United States

  • CAN Community Health

    RECRUITING

    Tampa, Florida, 33602, United States

  • CAN Community Health

    RECRUITING

    Las Vegas, Nevada, 89104, United States

  • Midway Specialty Care Center

    RECRUITING

    Ft. Pierce, Florida, 34982, United States

  • Midway Specialty Care Center

    RECRUITING

    Orlando, Florida, 32819, United States

  • Midway Specialty Care Center

    RECRUITING

    Temple Terrace, Florida, 33617, United States

  • Midway Specialty Care Center

    RECRUITING

    West Palm Beach, Florida, 33409, United States

  • Midway Specialty Care Center

    RECRUITING

    Wilton Manors, Florida, 33334, United States

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