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RECRUITING Phase 2

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

NCT04375800 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Doravirine
  • DRUG 2 NRTIs
  • DRUG DOR/3TC/TDF

Study Locations (20)

Gauteng

  • Perinatal HIV Research Unit ( Site 0602) — Johannesburg
  • Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603) — Johannesburg
  • Empilweni Services and Research Unit ( Site 0604) — Johannesburg

Mexico City

  • Instituto Nacional de Pediatria ( Site 0701) — Coyoacán
  • Hospital Infantil de Mexico Federico Gomez ( Site 0702) — Mexico City

Western Cape

  • Family Clinic Research With UBUNTU ( Site 0605) — Cape Town
  • Be Part Yoluntu Centre ( Site 0606) — Paarl

Colorado

  • University of Colorado at Denver ( Site 0108) — Aurora

Georgia

  • Emory Children's Center ( Site 0103) — Atlanta

Antioquia

  • Clinica Somer ( Site 1003) — Rionegro

Atlántico

  • Ciensalud Ips S A S ( Site 1001) — Barranquilla

Valle del Cauca Department

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

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2021-02-03
Est. Completion 2034-04-11
Phase Phase 2

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04375800

The ClinicalTrials.gov registry entry for NCT04375800 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Human Immunodeficiency Virus (HIV) Infection appearing as the primary indexed condition, and to 3 interventions — of which Doravirine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04375800 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Gauteng, Mexico City, Western Cape. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04375800 about?

NCT04375800 is a clinical study titled "Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)". 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 the...

What is the current status of trial NCT04375800?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2021-02-03. Estimated completion is 2034-04-11.

What conditions does trial NCT04375800 study?

This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV) Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04375800?

The interventions under investigation include: Doravirine (DRUG), 2 NRTIs (DRUG), DOR/3TC/TDF (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04375800?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04375800 being conducted?

This trial has 20 study locations across Colorado, Georgia, Antioquia, Atlántico, Valle del Cauca Department. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial