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

Description

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.

Conditions

Human Immunodeficiency Virus (HIV) Infection

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Study Overview

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Study Details

Study overview

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.

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg

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

Condition
Human Immunodeficiency Virus (HIV) Infection
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado at Denver ( Site 0108), Aurora, Colorado, United States, 80045

Atlanta

Emory Children's Center ( Site 0103), Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

4 Weeks to 11 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2034-04-11