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HIV patients successfully switch from shots to daily pill in new study

NCT ID NCT06104306

Disease control Sponsor: Gilead Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looked at 33 adults with well-controlled HIV who switched from a monthly injectable treatment (CAB+RPV) to a daily oral pill (B/F/TAF). The main goal was to check if the switch was safe, especially for those who couldn't or didn't want to continue injections. Over 12 weeks, researchers monitored for serious side effects and lab changes. The study found that switching to the oral pill was a safe option for these patients.

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

33 people

The number who actually took part.

Started

Dec 2023

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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.

Key Inclusion Criteria: * People with human immunodeficiency virus type 1 (HIV-1) (PWH) or provider decision to switch off cabotegravir + rilpivirine (CAB+RPV) intramuscular (IM) injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). * Currently virologically suppressed (HIV-1 ribonucleic acid (RNA) \< 50 copies/mL) on CAB+RPV IM injections every 2 months. * Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections. * Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV. * Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit. * No documented or suspected resistance to bictegravir, emtricitabine, or tenofovir. Key Exclusion Criteria: * History of B/F/TAF intolerance. * History of previous integrase strand-transfer inhibitor (INSTI) virologic failure including CAB+RPV. * Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug. * Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies) * Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease

As listed by the trial registrant

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

HIV-1-infection

Contacts and locations

Locations

  • APHM - Hospital Sainte Marguerite

    Marseille, France

  • BIOS Clinical Research

    Palm Springs, California, 92262, United States

  • Bliss Health

    Orlando, Florida, 32806, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CHR Orleans

    Orléans, 45100, France

  • CHU Bordeaux - Hopital Saint-Andre

    Bordeaux, 33075, France

  • Centre Hospitalier Annecy Genevois

    Pringy, 74374, France

  • Franco Felizarta, MD

    Bakersfield, California, 93301, United States

  • HU de Strasbourg - Nouvel Hopital Civil

    Strasbourg, France

  • Hamilton Health Sciences-SIS Clinic

    Hamilton, L8L2X2, Canada

  • Indiana University Infectious Diseases Research

    Indianapolis, Indiana, 46202, United States

  • Las Vegas Research Center

    Las Vegas, Nevada, 89106, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • MultiCare Rockwood Main Clinic

    Spokane, Washington, 99202, United States

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • St. Michael's Hospital

    Toronto, M5B 1W8, Canada

  • UC San Diego AntiViral Research Center (AVRC)

    San Diego, California, 92103, United States

  • University Health Network - Toronto General Hospital

    Toronto, M5G 2C4, Canada

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