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New HIV pill combo could simplify treatment for kids

NCT ID NCT06532656

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new combination of two HIV drugs, bictegravir and lenacapavir, in children and adolescents aged 2 to 17 with HIV-1. The goal is to see if this once-daily pill is safe and works well enough to replace more complex daily medication routines. About 75 participants who already have controlled HIV will take the drug, and researchers will monitor drug levels, side effects, and lab results for 24 weeks.

What this could mean

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

Active substance
Bictegravir/Lenacapavir (BIC/LEN) combination tablets
What this could lead to
If successful, this could offer a simpler, once-daily pill option for children and teens with HIV-1 who currently need complex daily regimens.
What could go wrong
This is an early-to-mid stage study with only 75 participants, so results may not apply to all. Side effects or lack of effectiveness in younger children 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 75 people

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

Started

Nov 2024

Expected to finish

Dec 2030

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

2 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: * Age and body weight at screening: * Cohort 1: ≥ 12 years to \< 18 years weighing ≥ 35 kg. * Cohort 2: ≥ 6 years to \< 12 years weighing ≥ 25 kg to \< 35 kg. * Cohort 3: ≥ 2 years to \< 6 years weighing ≥ 10 kg to \< 25 kg. * On a complex ARV regimen. Complex regimens are any ARV therapy that is not a single-tablet regimen taken once daily (eg, \> 1 tablet or any other formulation a day). * Documented plasma HIV-1 ribonucleic acid (RNA) levels must be \< 50 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is \< 50 copies/mL) in the last 6 months prior to screening (at least 1 measure prior to screening). * Plasma HIV-1 RNA levels \< 50 copies/mL at screening. * No documented or suspected resistance to integrase strand transfer inhibitors (mutations T66A/I/K, E92G/Q/V, G118R, F121C/Y, G140R, Y143C/H/R, S147G, Q148H/K/R, N155H/S, or R263K in the integrase gene). * The following laboratory parameters at screening: * Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 using the Bedside Schwartz formula. * Absolute neutrophil count \> 0.50 cells/L (\> 500 cells/mm3). * Hemoglobin ≥ 85 g/L (\> 8.5 g/dL). * Platelets ≥ 50 cells/L (≥ 50,000 cells/mm3). * Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 x upper limit of normal. * Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL). Key Exclusion Criteria: * CD4 cell count \< 200 cells/mm\^3. * CD4 percentage \< 20%. * Life expectancy ≤ 1 year. * An opportunistic illness indicative of Stage 3 HIV diagnosed within the 30 days prior to screening. * Evidence of active pulmonary or extrapulmonary tuberculosis within 3 months prior to screening. * Acute hepatitis within 30 days prior to screening. * Positive hepatitis C virus (HCV) antibody with detectable HCV RNA (participants positive for HCV antibody will have an HCV RNA test performed). * Positive hepatitis B surface antigen (HBsAg) or positive hepatitis B virus (HBV) core antibody (antibody against hepatitis B core antigen \[anti-HBc\]) at screening. If a participant is negative for HBsAg and positive for anti-HBc but HBV DNA is undetectable, the participant may be enrolled. * A history of or current decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).Current alcohol or substance use judged by the investigator to potentially interfere with the participant's study compliance. 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

  • ASST FBF Sacco Ospedale Sacco

    Milan, 20157, Italy

  • Ann and Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60614, United States

  • Be Part Yoluntu

    Cape Town, 7646, South Africa

  • Children's National Hospital

    Washington D.C., District of Columbia, 20010, United States

  • Clinical Research Institute of South Africa (CRISA)

    KwaDukuza, 4449, South Africa

  • Durban International Clinical Research Site, Enhancing Care Foundation

    Durban, 3629, South Africa

  • FAMCRU Ukwanda School for Rural Health

    Cape Town, 7505, South Africa

  • Grady Ponce de Leon Center

    Atlanta, Georgia, 30308, United States

  • Helios Salud S.A

    Buenos Aires, C1141ACG,, Argentina

  • Hospital General Universitario Gregorio Marano

    Madrid, 28007, Spain

  • Hospital Universitario 12 De Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali

    Roma, 00165, Italy

  • Khomanani Health Research and Wellness Centre

    Ka-Majosi, 944, South Africa

  • Monti Clinical Research Centre

    East London, 5219, South Africa

  • Nkanyezi VIDA Research Unit

    Johannesburg, 2112, South Africa

  • Perinatal HIV Research Unit

    Johannesburg, 1862, South Africa

  • Setshaba Research Centre

    Soshanguve, 0152, South Africa

  • The Aurum Institute: Pretoria Clinical Research Centre

    Pretoria, 0087, South Africa

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Wits RHI Shandukani Research Centre CRS

    Johannesburg, 2038, South Africa

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