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Could a shot replace daily HIV pills? new trial tests injectable combo

NCT ID NCT07708727

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tests whether an injectable combination of two experimental drugs, GS-3242 and lenacapavir, can control HIV-1 as well as the daily pill Biktarvy. About 700 people with HIV who have never taken antiviral treatment will receive either the injectable regimen or the standard oral medication. The goal is to see if the shots can keep the virus at undetectable levels over several months, potentially offering a more convenient treatment option.

What this could mean

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

Active substance
an injectable combination of GS-3242 and lenacapavir
What this could lead to
If successful, this could offer a long-acting injectable alternative to daily pills for people newly diagnosed with HIV, simplifying treatment and improving adherence.
What could go wrong
This is an early-to-mid-stage trial, so the injectable regimen may not prove as effective or safe as the current standard of care. Side effects from the injections or the drugs themselves are possible.

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

About 700 people

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

Started

Jul 2026

Expected to finish

Apr 2033

An estimate. End dates often move.

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 ribonucleic acid (RNA) ≥ 500 copies/mL at screening. * Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening. Key Exclusion Criteria: * Prior usage of, or exposure to LEN or GS-3242 * Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine. 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

How to take part

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

  1. The places running it

    11 sites in 3 countries. 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

  • HOPE Clinical Research

    RECRUITING

    San Juan, PR, 00909, Puerto Rico

  • KC care Health Center

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Metro Infectious Disease Consultants, P.L.L.C

    RECRUITING

    Decatur, Georgia, 30033, United States

  • Midway Immunology and Research Center

    RECRUITING

    Ft. Pierce, Florida, 34982, United States

  • North Texas Infectious Diseases Consultants, PA

    RECRUITING

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center, PA

    RECRUITING

    Florida City, Florida, 32803, United States

  • Prism Health North Texas

    RECRUITING

    Dallas, Texas, 75208, United States

  • St Hope Foundation, Inc,

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Texas Centers for Infectious Disease Associates

    RECRUITING

    Fort Worth, Texas, 76109, United States

  • Triple O Research Institute, P.A.

    RECRUITING

    West Palm Beach, Florida, 33401, United States

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