Testing a new HIV medication for children under 12 years old

Plain-English translation of NCT04375800 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study is testing a medication called to see if it works well and is safe for children with HIV who are under 12 years old and weigh less than 45 kilograms. Some children will take by itself along with two other HIV medications, while others will take a combination pill that contains plus two additional HIV medicines. The trial will follow these children for 96 weeks to measure how well the medication controls their HIV and what side effects, if any, they experience.

HIV medications that are safe and effective for very young children are limited. This medication has shown promise in adults, so researchers want to test whether it works equally well for children and to find the right doses for different weights.

Do you qualify?

You likely qualify if…

you have been diagnosed with HIV type 1 infection
you are either treatment-naïve (have never taken HIV medications) or have taken HIV medicines for at least 3 months with your virus controlled to very low levels
you weigh more than 3 kilograms but less than 45 kilograms
if you are a girl or woman of childbearing age, you are using reliable contraception or not pregnant, and you have a negative pregnancy test within 24 hours before starting

You likely don't qualify if…

you have kidney disease or liver disease
you have active hepatitis or hepatitis B co-infection
you have tuberculosis or are taking tuberculosis medications
you are known to be resistant to this medication, or you have had high levels of HIV in your blood after being on certain other HIV medications for at least 3 months
you have a condition that prevents you from taking oral medicines in pellet or granule form

What participation looks like

You or your child will visit the research clinic regularly over 96 weeks to take the assigned medication — either with two other HIV medicines, or a three-in-one combination pill. At each visit, the study team will check your health, do blood tests to see how well the medication is working and to watch for side effects, and answer any questions. If the medication is working well after 96 weeks, you may be able to continue it for up to an additional 224 weeks in an extension study.

AI-generated summary from trial data · Jul 20, 2026 · Not medical advice

Testing a new HIV medication for children under 12 years old

What is this trial?

Do you qualify?

What participation looks like

Trial locations