Doravirine treatment for HIV-infected children under 12 years old

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Emory Children's Center ( Site 0103)
  Atlanta, Georgia, United States Recruiting
• Clinica Somer ( Site 1003)
  Rionegro, Antioquia, Colombia Recruiting
• Ciensalud Ips S A S ( Site 1001)
  Barranquilla, Atlántico, Colombia Recruiting
• Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1100)
  Santo Domingo, Dominican Republic Recruiting
• Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1201)
  Guatemala City, Guatemala Recruiting
• Perinatal HIV Research Unit ( Site 0602)
  Johannesburg, Gauteng, South Africa Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.