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

Conditions

• Human Immunodeficiency Virus (HIV) Infection

Eligibility Criteria

Sex

ALL

Age

4 Weeks - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Doravirine — DRUG
  Administered orally
• 2 NRTIs — DRUG
  Administered orally
• DOR/3TC/TDF — DRUG
  Administered orally

Study Details

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.

Key Dates

Start date

Feb 3, 2021

Status verified

Apr 2026

Primary completion

Nov 12, 2028

Completion

Apr 11, 2034

Study Design

Enrollment

84 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF
  Participants receive doravirine (DOR) at 7.2 mg to 100 mg, based on weight, PLUS 2 nucleoside/nucleotide analog reverse transcriptase inhibitors (NRTIs), based on local label, for 96 weeks, OR a fixed-dose combination (FDC) of doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), based on weight, for 96 weeks.

Primary Outcome Measure

Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Postdose (AUC0-24hr) of Doravirine (DOR) Following Once-Daily Dosing in Plasma at Steady-State [ Time Frame: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (2)

Find similar trials in Aurora, CO

Related Studies

• Strategies to AchieVe Viral Suppression for Youth With HIV
  Recruiting · Johns Hopkins University · Baltimore, Maryland