Could a Two-Drug pill replace triple therapy for kids with HIV?

NCT ID NCT04337450

Ongoing Disease control Sponsor: PENTA Foundation Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a two-drug combination (dolutegravir and lamivudine) is as safe and effective as the standard three-drug HIV treatment for children aged 2 to 15. About 386 children who already have undetectable HIV levels will take either the two-drug pill or their usual three-drug regimen. The goal is to see if the simpler treatment can keep the virus suppressed for up to 96 weeks.

What this could mean

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

Active substance: dolutegravir and lamivudine (two anti-HIV medicines)
What this could lead to: If successful, this could offer a simpler, two-drug daily pill for children with HIV, reducing side effects and treatment burden while maintaining viral suppression.
What could go wrong: This is a mid-stage trial with 386 children, so results may not apply to all. There is a risk that the two-drug combo may not suppress the virus as well as three-drug regimens, leading to viral rebound.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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 INFECTIONS

Contacts and locations

Locations

Baylor

Kampala, Uganda
Birmingham Heartlands Hospital

Birmingham, United Kingdom
Chiangrai Prachanukroh Hospital

Chiang Rai, Thailand
Great Ormand Street Hospital

London, United Kingdom
Hospital Universitario 12 de Octubre

Madrid, Spain
Joint Clinical Research Centre

Kampala, Uganda
Khon Kaen Hospital

Khon Kaen, Thailand
King Edward VIII Hospital

Durban, South Africa
MUJHU

Kampala, Uganda
Nakornping Hospital

Chiang Mai, Thailand
PHRU

Soweto, South Africa
PHRU Klerksdorp

Klerksdorp, South Africa
Prapokklao Hospital

Chanthaburi, Thailand
St. Mary's Hospital

London, United Kingdom

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