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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST FBF Sacco Ospedale Sacco
Milan, 20157, Italy
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Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614, United States
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Be Part Yoluntu
Cape Town, 7646, South Africa
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Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
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Clinical Research Institute of South Africa (CRISA)
KwaDukuza, 4449, South Africa
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Durban International Clinical Research Site, Enhancing Care Foundation
Durban, 3629, South Africa
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FAMCRU Ukwanda School for Rural Health
Cape Town, 7505, South Africa
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Grady Ponce de Leon Center
Atlanta, Georgia, 30308, United States
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Helios Salud S.A
Buenos Aires, C1141ACG,, Argentina
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Hospital General Universitario Gregorio Marano
Madrid, 28007, Spain
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Hospital Universitario 12 De Octubre
Madrid, 28041, Spain
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Hospital Universitario La Paz
Madrid, 28046, Spain
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IRCCS Ospedale Pediatrico Bambino Gesu, UOS Infezioni Complesse e Perinatali
Roma, 00165, Italy
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Khomanani Health Research and Wellness Centre
Ka-Majosi, 944, South Africa
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Monti Clinical Research Centre
East London, 5219, South Africa
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Nkanyezi VIDA Research Unit
Johannesburg, 2112, South Africa
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Perinatal HIV Research Unit
Johannesburg, 1862, South Africa
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Setshaba Research Centre
Soshanguve, 0152, South Africa
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The Aurum Institute: Pretoria Clinical Research Centre
Pretoria, 0087, South Africa
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University of South Florida
Tampa, Florida, 33612, United States
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Wits RHI Shandukani Research Centre CRS
Johannesburg, 2038, South Africa
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