New HIV pill combo could simplify treatment for kids

NCT ID NCT06532656

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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