Condition: Human Immunodeficiency Virus (HIV) Infection · Sponsor: Merck Sharp & Dohme LLC
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.
This description comes directly from the study's public registry record.
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| University of Colorado at Denver ( Site 0108) | Aurora, Colorado, United States | Completed |
| Emory Children's Center ( Site 0103) | Atlanta, Georgia, United States | Recruiting |
| Clinica Somer ( Site 1003) | Rionegro, Antioquia, Colombia | Recruiting |
| Ciensalud Ips S A S ( Site 1001) | Barranquilla, Atlántico, Colombia | Recruiting |
| CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002) | Cali, Valle del Cauca Department, Colombia | Completed |
| Instituto Nacional de Pediatria ( Site 0701) | Coyoacán, Mexico City, Mexico | Completed |
| Hospital Infantil de Mexico Federico Gomez ( Site 0702) | Mexico City, Mexico City, Mexico | Active Not Recruiting |
| Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700) | Mérida, Yucatán, Mexico | Completed |
| Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506) | Kemerovo, Kemerovo Oblast, Russia | Active Not Recruiting |
| Clinical Centre for Prevention and Control of AIDS ( Site 0504) | Krasnodar, Krasnodarskiy Kray, Russia | Completed |
| Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507) | Krasnoyarsk, Krasnoyarsk Krai, Russia | Completed |
| Infectious Clinical Hospital #2 ( Site 0501) | Moscow, Moscow, Russia | Completed |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04375800