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Weekly HIV pill shows promise but study halted early

NCT ID NCT06613685

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a once-weekly oral combination of two experimental drugs (lepetegravir and lenacapavir pacfosacil) could control HIV as well as the standard daily pill Biktarvy. It enrolled 73 people newly diagnosed with HIV-1 who had never taken HIV medication. The study was terminated early, so we have limited data on its effectiveness and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lepetegravir and lenacapavir pacfosacil (oral weekly combination)
What this could lead to
If successful, this could offer a once-weekly pill option for HIV control, reducing the burden of daily medication.
What could go wrong
The study was terminated early with only 73 participants, so results are limited. Weekly dosing may not suppress the virus as effectively as daily therapy in all 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

73 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2026

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: * HIV-1 RNA ≥ 500 copies/mL at screening. * Antiretroviral (ARV) treatment-naive, except the use of oral pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or F/TAF, up to 1 month prior to screening. Key Exclusion Criteria: * Prior use of any long acting parenteral antiretrovirals (ARVs) such as monoclonal antibodies, broadly neutralizing antibodies targeting HIV-1, LEN, injectable cabotegravir (including oral cabotegravir lead-in), and/or injectable rilpivirine. * Documented resistance to the integrase strand-transfer inhibitor class, specifically, resistance-associated mutations E92G/Q, G118R, F121Y, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene. * Any of the following laboratory values at screening: 1. CD4 cell count \< 200 cells/mm3 at screening. 2. Estimated glomerular filtrations arate \< 60 mL/min according to the Modification of Diet in Renal Disease formula. 3. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) \> 1.5 × upper limit of normal (ULN). 4. Direct bilirubin \> 1.5 × ULN. 5. Platelets count \< 50,000 cells/mm3. 6. Hemoglobin \< 8.0 g/dL. * Active or occult hepatitis B virus infection. * Active hepatitis C virus infection. 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

  • CRISMO Research Center

    Germiston, 1401, South Africa

  • Chronic Viral Illness Service / McGill University Health Centre

    Montreal, H4A 3J1, Canada

  • Clinical Hospital of Infectious Diseases and Pneumophysiology Dr. Victor Babes Timisoara

    Timișoara, Romania

  • Clinical Research Institute of South Africa (CRISA)

    KwaZulu-Natal, 4449, South Africa

  • Clinique Médicale L'Actuel

    Montreal, H2L 4P9, Canada

  • Durban International Clinical Research Site, Enhancing Care Foundation

    Durban, 4013, South Africa

  • Emory University Hospital Midtown Infectious Disease Clinic

    Atlanta, Georgia, 30308, United States

  • FPD Ndevana Community Research Site

    Ndevana, 5660, South Africa

  • Floridian Clinical Research, LLC

    Miami Lakes, Florida, 33016, United States

  • Georgetown University Medical School

    Washington D.C., District of Columbia, 20007, United States

  • HOPE Clinical Research

    San Juan, PR, 00909, Puerto Rico

  • Hospital Arnau de Vilanova de Valencia

    Valencia, 46015, Spain

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario Alvaro Cunqueiro

    Pontevedra, 36312, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • ICH Study Center GmbH & Co. KG

    Hamburg, 20146, Germany

  • Institutul National De Boli Infectioase Prof. Dr. Matei Bals

    Bucharest, 021105, Romania

  • JOSHA Research

    Bloemfontein, 9301, South Africa

  • Klinikum rechts der Isar, Technische Universität München, Klinik und Poliklinik für Innere Medizin II

    München, 81675, Germany

  • Medical University of South Carolina (MUSC) Research Nexus

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover, Klinik für Rheumatologie und Immunologie, Gebäude K14

    Hanover, 30625, Germany

  • Mercer University, Department of Internal Medicine

    Macon, Georgia, 31201, United States

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720, United States

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982, United States

  • Mills Clinical Research

    West Hollywood, California, 90046, United States

  • MultiCare Rockwood Main Clinic

    Spokane, Washington, 99202, United States

  • NYU Langone Health Vaccine Center

    New York, New York, 10016, United States

  • North Texas Infectious Diseases Consultants, PA

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center

    Orlando, Florida, 32803, United States

  • Ottawa Hospital Research Institute

    Ottawa, K1H 8L6, Canada

  • Prism Health North Texas, Aids Arms

    Dallas, Texas, 75208, United States

  • Proyecto ACTU

    San Juan, PR, 00935, Puerto Rico

  • Punkt Zdrowia

    Gdansk, 80-172, Poland

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102, United States

  • Samodzielny Publiczny Wojewódzki Szpital Zespolony w Szczecinie

    Szczecin, 71-455, Poland

  • Spitalul Clinic De Boli Infectioase Cluj-Napoca

    Cluj-Napoca, 400003, Romania

  • Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu

    Bucharest, Romania

  • Spitalul Clinic de Boli Infectioase Constanta

    Constanța, 00709, Romania

  • St Hope Foundation, Inc.

    Bellaire, Texas, 77401, United States

  • Synergy Biomed Research Institute

    East London, 5241, South Africa

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104, United States

  • The Aurum Institute Tembisa Clinic 4

    Tembisa, 1632, South Africa

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407, United States

  • UAB 1917 Research Clinic

    Birmingham, Alabama, 35222, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • Unidade Local de Saude de Amadora Sinatra EPE, Hospital Prof. Doutor Fernando Fonseca

    Amadora, 2720- 276, Portugal

  • Unidade Local de Saúde de Lisboa Ocidental E.P.E. - Hospital Egas Moniz

    Lisbon, 1249-019, Portugal

  • Unidade Local de Saúde de Santo António, E.P.E.

    Porto, 4050, Portugal

  • Unidade Local de Saúde de Santo Maria E.P.E. - Hospital Santa Maria

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saúde de São João E.P.E.

    Porto, 4200-319, Portugal

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I, Immunologische Studienambulanz

    Bonn, 53127, Germany

  • Universitätsmedizin Essen, Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie, HPSTD-Ambulanz

    Essen, 45122, Germany

  • WITS RHI Research Centre

    Johannesburg, 2038, South Africa

  • Wojewódzki Szpital Obserwacyjno-Zakaźny im. Tadeusza Browicza

    Bydoszcz, 85-030, Poland

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