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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 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. The trial reports 20 study locations across 16 states.
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.
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 |
Interested in This Trial?
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, categorized as Phase 2. 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 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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