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RecruitingPhase 2NCT04375800

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

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

Sponsor

Merck Sharp & Dohme LLC

Enrollment

84 participants

Start Date

Feb 3, 2021

Study Type

INTERVENTIONAL

Conditions

Human Immunodeficiency Virus (HIV) Infection

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.

Eligibility

Min Age: 4 WeeksMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new HIV medication called doravirine (DOR) in children aged 4 weeks to under 12 years who are living with HIV and weigh less than 45 kg. The goal is to find the right dose and assess how well and how safely it works in young children who are either starting HIV treatment for the first time or switching from another regimen. **You may be eligible if...** - Your child has confirmed HIV-1 infection - Your child weighs more than 3 kg and less than 45 kg - Your child is either new to HIV treatment or has had a stable, suppressed viral load (undetectable HIV in the blood) for at least 3 months - Your child is not pregnant or breastfeeding (if female and of childbearing potential, contraception is required) **You may NOT be eligible if...** - Your child has kidney or liver disease - Your child has a history of any cancer - Your child has pancreatitis - Your child has active hepatitis B, active tuberculosis, or an AIDS-defining opportunistic infection - Your child has known resistance to doravirine - Your child has previously had high viral loads while on a similar class of HIV drugs (NNRTIs) - Your child is on immune-suppressing medications or has been in another drug study recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDoravirine

Administered orally

DRUG2 NRTIs

Administered orally

DRUGDOR/3TC/TDF

Administered orally

Locations(24)

University of Colorado at Denver ( Site 0108)

Aurora, Colorado, United States

Emory Children's Center ( Site 0103)

Atlanta, Georgia, United States

Clinica Somer ( Site 1003)

Rionegro, Antioquia, Colombia

Ciensalud Ips S A S ( Site 1001)

Barranquilla, Atlántico, Colombia

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

Cali, Valle del Cauca Department, Colombia

Instituto Nacional de Pediatria ( Site 0701)

Coyoacán, Mexico City, Mexico

Hospital Infantil de Mexico Federico Gomez ( Site 0702)

Mexico City, Mexico City, Mexico

Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)

Mérida, Yucatán, Mexico

Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)

Kemerovo, Kemerovo Oblast, Russia

Clinical Centre for Prevention and Control of AIDS ( Site 0504)

Krasnodar, Krasnodarskiy Kray, Russia

Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)

Krasnoyarsk, Krasnoyarsk Krai, Russia

Infectious Clinical Hospital #2 ( Site 0501)

Moscow, Moscow, Russia

FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)

Saint Petersburg, Sankt-Peterburg, Russia

FARMOVS PTY LTD ( Site 0601)

Bloemfontein, Free State, South Africa

Perinatal HIV Research Unit ( Site 0602)

Johannesburg, Gauteng, South Africa

Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)

Johannesburg, Gauteng, South Africa

Empilweni Services and Research Unit ( Site 0604)

Johannesburg, Gauteng, South Africa

King Edward Hospital ( Site 0600)

Durban, KwaZulu-Natal, South Africa

Family Clinic Research With UBUNTU ( Site 0605)

Cape Town, Western Cape, South Africa

Be Part Yoluntu Centre ( Site 0606)

Paarl, Western Cape, South Africa

Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)

Plettenberg Bay, Western Cape, South Africa

Siriraj Hospital ( Site 0901)

Bangkok, Bangkok, Thailand

Research Institute for Health Sciences ( Site 0902)

Chiang Mai, Thailand

Faculty of Medicine - Khon Kaen University ( Site 0903)

Khon Kaen, Thailand

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NCT04375800

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