NCT04375800 · Merck Sharp & Dohme LLC
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Ages 4 Weeks to <12 Years and <45 kg (MK-1439-066)
What this study is about
This is a single-group, where both patients and doctors know the treatment given, 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 how the drug moves through the body (PK) of doravirine (DOR) \[MK-1439\] when given in combinat
View original scientific 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.
Interventions
DRUG
Doravirine
Administered orally
DRUG
2 NRTIs
Administered orally
DRUG
DOR/3TC/TDF
Administered orally
Primary outcome 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-State
Time frame: Intensive 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-State
Time frame: Intensive 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-State
Time frame: Intensive 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-State
Time frame: Intensive 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-State
Time frame: Intensive 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-State
Time frame: Intensive 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-State
Time frame: Intensive 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-State
Time frame: Intensive 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)
Time frame: 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 AE
Time frame: Up 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 Death
Time frame: Up 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 AE
Time frame: 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 Discontinuing From Study Intervention Due to a Drug-Related AE
Time frame: Up 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Study Extension Inclusion Criteria:
- Has completed the Week 96 visit.
- Is considered, in the opinion of the investigator, to have derived benefit from treatment with DOR plus the 2 NRTIs selected by the investigator, or 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 plus 2 NRTIs sel
Where
- Aurora, Colorado
- Atlanta, Georgia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations