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New HIV pill study aims to help young children

NCT ID NCT04375800

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests an HIV medicine called doravirine in children aged 4 weeks to under 12 years who weigh less than 45 kg. The goal is to see how the drug works in their bodies and if it is safe. About 84 children who are either new to treatment or already have the virus under control will take part.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2021

Expected to finish

Apr 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

4 weeks to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Has human immunodeficiency virus type 1 (HIV-1) infection confirmed at screening * Has appropriate treatment history defined as treatment-naïve (TN) or with documented virologic suppression (HIV-1 ribonucleic acid \[RNA\] \<50 copies/mL) on stable combination antiretroviral therapy (cART) for ≥3 months * Body weight is \>3 kg to \<45 kg * If female, is not pregnant or breastfeeding, and one of the following applies: * Is not a woman of childbearing potential (WOCBP) * Is a WOCBP using an acceptable form of contraception, or is abstinent * If a WOCBP must have a negative pregnancy test (urine or serum) within 24 hours of the first dose of study intervention Study Extension Inclusion Criteria: * Has completed the Week 96 visit * Is considered, in the opinion of the investigator, to have derived benefit from treatment with doravirine (DOR) plus the 2 nucleoside/nucleotide analog reverse transcriptase inhibitor (NRTIs) selected by the investigator, or doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), by Week 96 of the study * Is considered, in the opinion of the investigator, to be a clinically appropriate candidate for additional treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) * Understands the procedures in the study extension and has provided (or have the participant's legally acceptable representative, if applicable, provide) documented informed consent/assent to enter the study extension and continue treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) until it is available locally in countries participating in the study or for up to an additional 224 weeks (whichever comes first) Exclusion Criteria: * Has evidence of renal disease * Demonstrates evidence of liver disease * Has clinical or laboratory evidence of pancreatitis * Has any history of malignancy * Has presence of any active acquired immunodeficiency syndrome (AIDS)-defining opportunistic Infection * Has an active diagnosis of hepatitis, including hepatitis B co-infection * Has current active tuberculosis and/or is being treated with a rifampicin-containing regimen * Has a medical condition that precludes absorption or intake of oral pellets/granules * Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study or interfere with participating for the entire duration of the study * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the treatment period * Has a documented or known virologic resistance to DOR * Has any history of viremia (HIV RNA \>1000 copies/mL) after at least 3 months on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen

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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.

Human immunodeficiency virus (HIV) infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Be Part Yoluntu Centre ( Site 0606)

    RECRUITING

    Paarl, Western Cape, 7626, South Africa

  • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002)

    COMPLETED

    Cali, Valle del Cauca Department, 760042, Colombia

  • Ciensalud Ips S A S ( Site 1001)

    RECRUITING

    Barranquilla, Atlántico, 080020, Colombia

  • Clinica Somer ( Site 1003)

    RECRUITING

    Rionegro, Antioquia, 054040, Colombia

  • Clinical Centre for Prevention and Control of AIDS ( Site 0504)

    COMPLETED

    Krasnodar, Krasnodarskiy Kray, 350015, Russia

  • Emory Children's Center ( Site 0103)

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Empilweni Services and Research Unit ( Site 0604)

    COMPLETED

    Johannesburg, Gauteng, 2093, South Africa

  • FARMOVS PTY LTD ( Site 0601)

    COMPLETED

    Bloemfontein, Free State, 9301, South Africa

  • FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)

    ACTIVE_NOT_RECRUITING

    Saint Petersburg, Sankt-Peterburg, 196645, Russia

  • Faculty of Medicine - Khon Kaen University ( Site 0903)

    RECRUITING

    Khon Kaen, 40002, Thailand

  • Family Clinic Research With UBUNTU ( Site 0605)

    RECRUITING

    Cape Town, Western Cape, 7505, South Africa

  • Hospital Infantil de Mexico Federico Gomez ( Site 0702)

    ACTIVE_NOT_RECRUITING

    Mexico City, Mexico City, 06720, Mexico

  • Infectious Clinical Hospital #2 ( Site 0501)

    COMPLETED

    Moscow, Moscow, 105275, Russia

  • Instituto Nacional de Pediatria ( Site 0701)

    COMPLETED

    Coyoacán, Mexico City, 04530, Mexico

  • King Edward Hospital ( Site 0600)

    RECRUITING

    Durban, KwaZulu-Natal, 4001, South Africa

  • Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)

    COMPLETED

    Krasnoyarsk, Krasnoyarsk Krai, 660049, Russia

  • Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)

    ACTIVE_NOT_RECRUITING

    Kemerovo, Kemerovo Oblast, 650056, Russia

  • Perinatal HIV Research Unit ( Site 0602)

    RECRUITING

    Johannesburg, Gauteng, 1864, South Africa

  • Research Institute for Health Sciences ( Site 0902)

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Siriraj Hospital ( Site 0901)

    RECRUITING

    Bangkok, Bangkok, 10700, Thailand

  • Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)

    COMPLETED

    Plettenberg Bay, Western Cape, 6600, South Africa

  • Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)

    COMPLETED

    Mérida, Yucatán, 97000, Mexico

  • University of Colorado at Denver ( Site 0108)

    COMPLETED

    Aurora, Colorado, 80045, United States

  • Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)

    RECRUITING

    Johannesburg, Gauteng, 2001, South Africa

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