🏛️ Verified NIH Record • Updated 2026-07-06

Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066) (NCT04375800)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

This is a single-group, open-label, multi-site study in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection, aged 4 weeks to \<12 years and weighing \<45 kg, who are treatment-naive (TN) or have been virologically suppressed (VS) on stable combination antiretroviral therapy (cART) for ≥3 months with no history of treatment failure. The primary objectives are: * To evaluate the steady state pharmacokinetics (PK) of doravirine (DOR) \[MK-1439\] when given in combination with 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs) or as part of the fixed-dose combination (FDC) of DOR/lamivudine (3TC)/tenofovir disproxil fumarate (TDF) in participants ≥6 to \<12 years and weighing ≥14 to \<45 kg. * To evaluate the safety and tolerability of DOR when given with 2 NRTIs or as part of the FDC of DOR/3TC/TDF, in participants ≥6 to 12 years and weighing ≥14 to \<45 kg, through Week 24.

Who can join: Review the eligibility criteria below.

Location: University of Colorado at Denver ( Site 0108) — Aurora, Colorado

Age range: 4 Weeks to 11 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (24 Sites)

  • University of Colorado at Denver ( Site 0108) — Aurora, Colorado
  • Emory Children's Center ( Site 0103) — Atlanta, Georgia
  • Clinica Somer ( Site 1003) — Rionegro, Antioquia
  • Ciensalud Ips S A S ( Site 1001) — Barranquilla, Atlántico
  • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002) — Cali, Valle del Cauca Department
  • Instituto Nacional de Pediatria ( Site 0701) — Coyoacán, Mexico City
  • Hospital Infantil de Mexico Federico Gomez ( Site 0702) — Mexico City, Mexico City
  • Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700) — Mérida, Yucatán
  • Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506) — Kemerovo, Kemerovo Oblast
  • Clinical Centre for Prevention and Control of AIDS ( Site 0504) — Krasnodar, Krasnodarskiy Kray
  • Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507) — Krasnoyarsk, Krasnoyarsk Krai
  • Infectious Clinical Hospital #2 ( Site 0501) — Moscow, Moscow
  • FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500) — Saint Petersburg, Sankt-Peterburg
  • FARMOVS PTY LTD ( Site 0601) — Bloemfontein, Free State
  • Perinatal HIV Research Unit ( Site 0602) — Johannesburg, Gauteng
  • Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603) — Johannesburg, Gauteng
  • Empilweni Services and Research Unit ( Site 0604) — Johannesburg, Gauteng
  • King Edward Hospital ( Site 0600) — Durban, KwaZulu-Natal
  • Family Clinic Research With UBUNTU ( Site 0605) — Cape Town, Western Cape
  • Be Part Yoluntu Centre ( Site 0606) — Paarl, Western Cape
  • Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607) — Plettenberg Bay, Western Cape
  • Siriraj Hospital ( Site 0901) — Bangkok, Bangkok
  • Research Institute for Health Sciences ( Site 0902) — Chiang Mai,
  • Faculty of Medicine - Khon Kaen University ( Site 0903) — Khon Kaen,

📞 Contact the Study Coordinator

Phone: (888) 577-8839

Email: Trialsites@msd.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗