Actively Recruiting
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-28
84
Participants Needed
24
Research Sites
687 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed HIV-1 infection at screening
- Treatment-naive or virologically suppressed on stable combination antiretroviral therapy for at least 3 months
- Body weight greater than 3 kg and less than 45 kg
- If female, not pregnant or breastfeeding and either not of childbearing potential or using acceptable contraception or abstinent
- Negative pregnancy test within 24 hours of first dose if woman of childbearing potential
- Completed Week 96 visit to enter study extension
- Considered by investigator to have benefited from doravirine-based treatment by Week 96
- Considered clinically appropriate for additional doravirine treatment in extension
- Provided informed consent/assent for study extension
You will not qualify if you...
- Evidence of renal disease
- Evidence of liver disease
- Clinical or laboratory evidence of pancreatitis
- History of malignancy
- Presence of any active AIDS-defining opportunistic infection
- Active hepatitis, including hepatitis B co-infection
- Current active tuberculosis or treatment with rifampicin-containing regimen
- Medical condition preventing absorption or intake of oral pellets/granules
- History or current condition, therapy, laboratory abnormality, or circumstance that may affect study results or participation
- Use or anticipated need for systemic immunosuppressive therapy, immune modulators, or prohibited therapy
- Participation in another interventional clinical study with investigational compound or device within 45 days prior to Day 1
- Known or documented resistance to doravirine
- History of viremia (HIV RNA >1000 copies/mL) after at least 3 months on NNRTI-based regimen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
University of Colorado at Denver ( Site 0108)
Aurora, Colorado, United States, 80045
Completed
2
Emory Children's Center ( Site 0103)
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Clinica Somer ( Site 1003)
Rionegro, Antioquia, Colombia, 054040
Actively Recruiting
4
Ciensalud Ips S A S ( Site 1001)
Barranquilla, Atlántico, Colombia, 080020
Actively Recruiting
5
CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002)
Cali, Valle del Cauca Department, Colombia, 760042
Actively Recruiting
6
Instituto Nacional de Pediatria ( Site 0701)
Coyoacán, Mexico City, Mexico, 04530
Completed
7
Hospital Infantil de Mexico Federico Gomez ( Site 0702)
Mexico City, Mexico City, Mexico, 06720
Active, Not Recruiting
8
Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)
Mérida, Yucatán, Mexico, 97000
Completed
9
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)
Kemerovo, Kemerovo Oblast, Russia, 650056
Actively Recruiting
10
Clinical Centre for Prevention and Control of AIDS ( Site 0504)
Krasnodar, Krasnodarskiy Kray, Russia, 350015
Completed
11
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)
Krasnoyarsk, Krasnoyarsk Krai, Russia, 660049
Completed
12
Infectious Clinical Hospital #2 ( Site 0501)
Moscow, Moscow, Russia, 105275
Completed
13
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)
Saint Petersburg, Sankt-Peterburg, Russia, 196645
Actively Recruiting
14
FARMOVS PTY LTD ( Site 0601)
Bloemfontein, Free State, South Africa, 9301
Completed
15
Perinatal HIV Research Unit ( Site 0602)
Johannesburg, Gauteng, South Africa, 1864
Actively Recruiting
16
Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)
Johannesburg, Gauteng, South Africa, 2001
Actively Recruiting
17
Empilweni Services and Research Unit ( Site 0604)
Johannesburg, Gauteng, South Africa, 2093
Completed
18
King Edward Hospital ( Site 0600)
Durban, KwaZulu-Natal, South Africa, 4001
Actively Recruiting
19
Family Clinic Research With UBUNTU ( Site 0605)
Cape Town, Western Cape, South Africa, 7505
Actively Recruiting
20
Be Part Yoluntu Centre ( Site 0606)
Paarl, Western Cape, South Africa, 7626
Actively Recruiting
21
Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)
Plettenberg Bay, Western Cape, South Africa, 6600
Completed
22
Siriraj Hospital ( Site 0901)
Bangkok, Bangkok, Thailand, 10700
Actively Recruiting
23
Research Institute for Health Sciences ( Site 0902)
Chiang Mai, Thailand, 50200
Actively Recruiting
24
Faculty of Medicine - Khon Kaen University ( Site 0903)
Khon Kaen, Thailand, 40002
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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