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Doravirine for Children with HIV-1 Infection

This study is testing a medication called doravirine (DOR) in children aged 4 weeks to less than 12 years old who have HIV-1 infection and weigh less than 45 kg. Researchers want to understand how doravirine is absorbed and processed by the body when given with two other anti-HIV medications (2 NRTIs) or as a combined pill called DOR/3TC/TDF. This study is for children who have never taken HIV medication before or who have their HIV under control with current treatment. The main goal is to measure the levels of doravirine in the blood over time to find the right dose for children. About 84 children are expected to join this study.

Study design
This is an open-label study, meaning everyone knows which treatment is being given. It involves one group of participants and will take place at multiple locations.
What's involved
Participants will have intensive blood draws at specific times up to 24 hours after taking the medication to measure drug levels. Those who complete 96 weeks may continue in an extension study for up to 224 additional weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants who complete the 96-week study may be eligible to continue receiving doravirine for up to an additional 224 weeks in an extension study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04375800

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

Recruiting
PHASE2Ages 4–11InterventionalTreatment
Merck Sharp & Dohme LLC
~84 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Doravirine2 NRTIsDOR/3TC/TDF

At a glance

Recruiting sites
11 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
+12 more outcomes measured

Conditions

Human Immunodeficiency Virus (HIV) Infection

Explore related trials

HIV InfectionHIV Infection

Where it's being run

24 sites across 18 states
Gauteng3
Western Cape3
Mexico City2
Thailand2
Colorado1
Georgia1
Antioquia1
Atlántico1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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 completed the Week 96 visit
Is considered, in the opinion of the investigator, to have derived benefit from treatment with doravirine (DOR) plus the 2 nucleoside/nucleotide analog reverse transcriptase inhibitor (NRTIs) selected by the investigator, or doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), by Week 96 of the study
Is considered, in the opinion of the investigator, to be a clinically appropriate candidate for additional treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF)
Understands the procedures in the study extension and has provided (or have the participant's legally acceptable representative, if applicable, provide) documented informed consent/assent to enter the study extension and continue treatment with DOR regimens (DOR plus 2 NRTIs selected by the investigator or DOR/3TC/TDF) until it is available locally in countries participating in the study or for up to an additional 224 weeks (whichever comes first)

Exclusion

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

What this trial measures

  • 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-StateIntensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose

    Per protocol, intensive pharmacokinetic (PK) sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr.

  • Maximum Concentration (Cmax) of DOR Following Once-Daily Dosing in Plasma at Steady-StateIntensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose

    Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax.

  • Concentration at 24 Hours (C24) of DOR Following Once-Daily Dosing in Plasma at Steady-StateIntensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose

    Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine C24.

  • Time to Maximum Concentration (Tmax) of DOR Following Once-Daily Dosing in Plasma at Steady-StateIntensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose

    Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Tmax.

  • AUC From 0 to 12 Hours Postdose (AUC0-12hr) of DOR Following Twice-Daily Dosing in Plasma at Steady-StateIntensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose

    Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine AUC0-12hr.

  • Cmax of DOR Following Twice-Daily Dosing in Plasma at Steady-StateIntensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose

    Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Cmax.

  • Concentration at 12 Hours (C12) of DOR Following Twice-Daily Dosing in Plasma at Steady-StateIntensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose

    Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine C12.

  • Tmax of DOR Following Twice-Daily Dosing in Plasma at Steady-StateIntensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose

    Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Tmax.

  • Percentage of Participants With ≥1 Adverse Event (AE)Up to 24 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.

  • Percentage of Participants With a Grade 3 or 4 AEUp to 24 weeks

    Grade 3 or 4 AEs are "severe symptoms that cause inability to perform usual social and functional activities with intervention or hospitalization indicated" (Grade 3), or "potentially life-threatening events" (Grade 4).

  • Percentage of Participants With Events of DeathUp to 24 weeks

    The percentage of participants with events of death at Week 24 will be reported.

  • Percentage of Participants Discontinuing From Study Intervention Due to an AEUp to 24 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study interventions.

  • Percentage of Participants Discontinuing From Study Intervention Due to a Drug-Related AEUp to 24 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, that is considered to be related to the study interventions.