Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04375800 · ClinicalTrials.gov registry record · Phase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
A Phase 2 study of Human Immunodeficiency Virus (HIV) Infection, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 20
- Study locations
NCT04375800: Recruiting Phase 2 study of Human Immunodeficiency Virus (HIV) Infection, sponsored by Merck Sharp & Dohme.
NCT04375800 is a Phase 2 study of Human Immunodeficiency Virus (HIV) Infection that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375800, a Phase 2 study of Human Immunodeficiency Virus (HIV) Infection, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Per protocol, intensive pharmacokinetic (PK) sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2034-04-11 |
| Phase | Phase 2 |
What NCT04375800 shows while recruiting
NCT04375800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
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.
NCT04375800 names 20 study sites across 16 states, led by Gauteng, Mexico City, Western Cape.
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.
What interventions are being tested in trial NCT04375800?
The interventions under investigation include: Doravirine (DRUG), 2 NRTIs (DRUG), DOR/3TC/TDF (DRUG).
Who is sponsoring clinical trial NCT04375800?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Human Immunodeficiency Virus (HIV) Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04375800's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,174 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02391519 · 84 participants
Effects of High Altitude on AMPK Activation
- NCT03838536 · 84 participants · NA
Synergistic Activity of Human Milk Nutrients and Infant Cognition
- NCT03884075 · 84 participants · Phase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
- NCT03894917 · 84 participants
Characterizing Disease Biology, Treatment and Toxicity in Older Adults With Hepatocellular Carcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI