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New Long-Acting HIV shot shows promise for kids and teens

NCT ID NCT06749054

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a long-acting HIV medicine called lenacapavir (Sunlenca®) in 12 adolescents and children with HIV who have tried other treatments. Participants take lenacapavir as pills and injections along with their other HIV drugs. The goal is to see if the combination is safe, tolerable, and effective at controlling the virus.

What this could mean

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

Active substance
lenacapavir (Sunlenca®) given as pills and injections, plus an optimized background regimen of other HIV medicines
What this could lead to
If it works, this could provide a long-acting, easier-to-take option for children and teens with HIV who have limited treatment choices.
What could go wrong
This is a small, early-phase study with only 12 participants, so results may not apply to everyone. Side effects or lack of effectiveness 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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 12 people

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

Started

Mar 2025

Expected to finish

Sep 2027

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

Up to 17 years

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: * Body weight at screening ≥ 35 kg. * On a stable failing antiretroviral (ARV) regimen for \> 8 weeks before screening and willing to continue the regimen until Day 1. * Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening. * Have previously changed their ARV regimen due to treatment failure. * ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access. * Able and willing to commit to taking LEN in combination with their OBR. * The following laboratory parameters at screening: 1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\^2 using Bedside Schwartz Formula. 2. Absolute neutrophil count \> 0.50 GI/L (\> 500 cells/mm\^3). 3. Hemoglobin ≥ 85 g/L (\> 8.5 g/dL). 4. Platelets ≥ 50 GI/L (≥ 50,000/mm\^3). 5. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal. 6. Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL). Key Exclusion Criteria: * Life expectancy ≤ 1 year. * An opportunistic illness requiring treatment within the 30 days prior to screening. * Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening. * Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening. * Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA undetectable, individual may be enrolled. 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

    8 sites in 2 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

  • Be Part Research Pty (Ltd)

    RECRUITING

    Paarl, 7626, South Africa

  • CRISMO Research Centre

    RECRUITING

    Germiston, 1401, South Africa

  • Clinical Research Institute of South Africa (CRISA)

    RECRUITING

    KwaDukuza, 4449, South Africa

  • Durban International Clinical Research Site, Enhancing Care Foundation

    RECRUITING

    KwaZulu - Natal, 4093, South Africa

  • FAMCRU

    RECRUITING

    Cape Town, 7505, South Africa

  • Grady Health System, Ponce De Leon Center

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Perinatal HIV Research Unit (PHRU)

    WITHDRAWN

    Soweto, 2013, South Africa

  • Rahima Moosa Mother and Child Hospital

    RECRUITING

    Johannesburg, 2112, South Africa

  • Wits RHI Shandukani Research Centre CRS

    RECRUITING

    Johannesburg, 2038, South Africa

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