Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Recruiting · NCT04375800 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
4 Weeks to 11 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Has human immunodeficiency virus type 1 (HIV-1) infection confirmed at screening
- Has appropriate treatment history defined as treatment-naïve (TN) or with documented virologic suppression (HIV-1 ribonucleic acid \[RNA\] \<50 copies/mL) on stable combination antiretroviral therapy (cART) for ≥3 months
- Body weight is \>3 kg to \<45 kg
- If female, is not pregnant or breastfeeding, and one of the following applies:
- Is not a woman of childbearing potential (WOCBP)
- Is a WOCBP using an acceptable form of contraception, or is abstinent
- If a WOCBP must have a negative pregnancy test (urine or serum) within 24 hours of the first dose of study intervention
- Study Extension Inclusion Criteria:
- Has completed the Week 96 visit
- Is considered, in the opinion of the investigator, to have derived benefit from treatment with doravirine (DOR) plus the 2 nucleoside/nucleotide analog reverse transcriptase inhibitor (NRTIs) selected by the investigator, or doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), by Week 96 of the study
- Is considered, in the opinion of the investigator, to be a clinically appropriate candidate for additional treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF)
- Understands the procedures in the study extension and has provided (or have the participant's legally acceptable representative, if applicable, provide) documented informed consent/assent to enter the study extension and continue treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) until it is available locally in countries participating in the study or for up to an additional 224 weeks (whichever comes first)
Exclusion criteria
- Has evidence of renal disease
- Demonstrates evidence of liver disease
- Has clinical or laboratory evidence of pancreatitis
- Has any history of malignancy
- Has presence of any active acquired immunodeficiency syndrome (AIDS)-defining opportunistic Infection
- Has an active diagnosis of hepatitis, including hepatitis B co-infection
- Has current active tuberculosis and/or is being treated with a rifampicin-containing regimen
- Has a medical condition that precludes absorption or intake of oral pellets/granules
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound results of the study or interfere with participating for the entire duration of the study
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or other prohibited therapy
- Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the treatment period
- Has a documented or known virologic resistance to DOR
- Has any history of viremia (HIV RNA \>1000 copies/mL) after at least 3 months on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen
Where it is running
24 locations listed across 2 US states.
- University of Colorado at Denver ( Site 0108) - Aurora, Colorado, United States
- Emory Children's Center ( Site 0103) - Atlanta, Georgia, United States
- Research Institute for Health Sciences ( Site 0902) - Chiang Mai, Thailand
- Faculty of Medicine - Khon Kaen University ( Site 0903) - Khon Kaen, Thailand
- Clinica Somer ( Site 1003) - Rionegro, Antioquia, Colombia
- Ciensalud Ips S A S ( Site 1001) - Barranquilla, Atlántico, Colombia
- Siriraj Hospital ( Site 0901) - Bangkok, Bangkok, Thailand
- 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
- 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
- King Edward Hospital ( Site 0600) - Durban, KwaZulu-Natal, South Africa
- Instituto Nacional de Pediatria ( Site 0701) - Coyoacán, Mexico City, Mexico
- Hospital Infantil de Mexico Federico Gomez ( Site 0702) - Mexico City, Mexico City, Mexico
- Infectious Clinical Hospital #2 ( Site 0501) - Moscow, Moscow, Russia
- FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500) - Saint Petersburg, Sankt-Peterburg, Russia
- CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002) - Cali, Valle del Cauca Department, Colombia
- 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
- Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700) - Mérida, Yucatán, Mexico