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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-11
SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

Qualifiers

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

Is not a woman of childbearing potential (WOCBP)

Disqualifiers

Has evidence of renal disease

Demonstrates evidence of liver disease

Has clinical or laboratory evidence of pancreatitis

Has any history of malignancy

Trial design

Treatments tested in this trial

  • Doravirine
  • 2 NRTIs
  • DOR/3TC/TDF

Treatment groups

84 Participants
are divided into 1 treatment group

Sponsors and collaborators