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

  • STATUS
    Recruiting
  • End date
    Nov 3, 2026
  • participants needed
    84
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 13 April 2022
immunodeficiency
antiretroviral therapy
tenofovir
lamivudine
HIV Vaccine
hiv-1 rna measurement

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 first primary objective is 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. The second primary objective is 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.

Details
Condition Human Immunodeficiency Virus (HIV) Infection
Treatment Doravirine, 2 NRTIs
Clinical Study IdentifierNCT04375800
SponsorMerck Sharp & Dohme Corp.
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Has HIV-1 infection confirmed at screening
Has treatment history defined as either TN or with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months on combination antiretroviral therapy (cART)
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

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
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