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Doravirine treatment for HIV-infected children under 12 years old

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg

PHASE2 · Merck Sharp & Dohme LLC · NCT04375800

This study is testing a new HIV treatment called doravirine in children under 12 to see if it's safe and effective for them.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment84 (estimated)
Ages4 Weeks to 11 Years
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionscART
Locations24 sites (Aurora, Colorado and 23 other locations)
Trial IDNCT04375800 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the pharmacokinetics and safety of doravirine (DOR) in pediatric participants aged 4 weeks to less than 12 years who are either treatment-naive or have been virologically suppressed on stable antiretroviral therapy. The study involves administering DOR in combination with two nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs) or as part of a fixed-dose combination with lamivudine and tenofovir. Participants will be monitored for safety and tolerability over a 24-week period, with the option to continue treatment in an extension study for up to 224 weeks. The trial is conducted across multiple sites in the United States and Colombia.

Who should consider this trial

Good fit: Ideal candidates include children aged 4 weeks to less than 12 years with confirmed HIV-1 infection who are either treatment-naive or have maintained viral suppression on stable therapy.

Not a fit: Patients who are older than 12 years or those who have a history of treatment failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective and safe option for managing HIV in young children.

How similar studies have performed: Other studies have shown promise in using doravirine for HIV treatment, indicating a potential for success with this approach in pediatric populations.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Aurora, Colorado and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Human Immunodeficiency Virus Infection

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.