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HIV drug data dive: what happens when young patients take darunavir or etravirine?

NCT ID NCT04194021

Knowledge-focused Sponsor: Elizabeth Glaser Pediatric AIDS Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are collecting health records from young people with HIV in ten African countries who have taken the drugs darunavir, etravirine, or both. The study follows their demographics, clinical and laboratory profiles, and HIV drug resistance over time. The goal is to understand real-world outcomes for children and young adults on these treatments, including those who transition out of donor-supported programs after age 25.

What this could mean

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

What this could lead to
If the data show these drugs work well in young people, it could help guide HIV treatment decisions in African countries and support programs for children and young adults.
What could go wrong
This is a data collection study, not a controlled experiment, so it can only show patterns, not prove cause and effect. Missing or incomplete records could limit what researchers can learn.

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

Study facts

What this study's own registry entry says, in plain language.

Participants

871 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All patients who ever received darunavir and/or etravirine before turning age 25 and residing in the following countries: Cameroon, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, Zimbabwe.

Ages

Up to 25 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ever received darunavir and/or etravirine. * Under age 25. * Residing in any of the following countries: Cameroon, Ethiopia, Eswatini, Kenya, Lesotho, Nigeria, Rwanda, Uganda, Zambia, and Zimbabwe. Exclusion Criteria: * Above age 25. * Residing in a country not participating in the New Horizons Collaborative.

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV/AIDS

Contacts and locations

Locations

  • Elizabeth Glaser Pediatric AIDS Foundation/Cameroon

    Yaoundé, Centre Region, Cameroon

  • Elizabeth Glaser Pediatric AIDS Foundation/Eswatini

    Mbabane, Hhohho Region, Eswatini

  • Elizabeth Glaser Pediatric AIDS Foundation/Kenya

    Nairobi, Kenya

  • Elizabeth Glaser Pediatric AIDS Foundation/Lesotho

    Maseru, Lesotho

  • Elizabeth Glaser Pediatric AIDS Foundation/Uganda

    Mbarara, Uganda

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