HIV-1 Treatment: Bictegravir/Lenacapavir for Kids and Teens

We are studying a new combination medication for children and adolescents with HIV-1 to see how well it works and how safe it is. The trial will also check if young patients find the medication easy to take.

6-12 months 6-10 visits Efficacy phase (II)Confirmation phase (III)Post-Trial Drug Access No Placebo Cost Reimbursement Partially Remote Investigational Medicines OralInfectious DiseasesPediatrics

What diseases are being studied?

Health conditions and diseases that the clinical trial is designed to study and treat.

Who can participate in the clinical trial?

These questions help us understand your situation so we can let the trial team know whether you might be a potential match. This is not a medical evaluation and is not part of the official screening, the study doctor will make the final decision..

What medicines are being studied?

Medicines that are officially approved for use in the European Union and considered safe by EMA. These medicines are already on the market and may be tested for new conditions or populations.

Sunlenca

Sunlenca is a medicine used to treat adults with HIV, especially those with virus resistant to multiple other HIV drugs.

What active substances are being studied?

Active substances that are officially approved for use in the European Union and considered safe by EMA. These substances are already on the market and may be tested for new conditions or populations.

Bictegravir

Bictegravir is a substance that blocks HIV integrase to prevent viral replication and help control infection.

Lenacapavir

Lenacapavir is a long-acting antiviral substance used to treat HIV by blocking the virus from multiplying by targeting its protective shell.

What experimental substances are being tested?

Experimental substances that are being investigated in this clinical trial. These are not yet approved for general use.

Bictegravir

Lenacapavir

Where is the clinical trial being conducted?

Locations and medical facilities where this clinical trial is currently recruiting or conducting research. Select the locations where you would like to participate.

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ASST Fatebenefratelli Sacco

SC di Pediatria ad indirizzo infettivologico

Baranzate, Italy

Ospedale Pediatrico Bambino Gesu

U.O.S. Infezioni complesse e perinatali

Rome, Italy

Hospital Universitario La Paz

Pediatrics Service

Chamartín, Spain

Sponsor: Gilead Sciences Inc.

Last updated: Nov 26, 2025

Disclaimer: Parts of this content have been automatically extracted from the EU Clinical Trials registry. While we strive for accuracy, please always contact the trial site or sponsor directly for correct and official information before making any decisions about participation. View on EU Clinical Trials.