Recruiting
Phase 2

Doravirine

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT04375800

Conditions

Human Immunodeficiency Virus (HIV) Infection

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Not accepted

Interventions

Doravirine

2 NRTIs

DOR/3TC/TDF

Study Details

Brief 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 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.

Conditions

Human Immunodeficiency Virus (HIV) Infection

Study ID

NCT04375800

Start date

Feb 3, 2021

Status verified date

Jul, 2026

Completion date

Apr 11, 2034

Anticipated

Primary completion date

Nov 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 11

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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 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 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
  • 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

Study Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Doravirine

Administered orally

2 NRTIs

Administered orally

DOR/3TC/TDF

Administered orally

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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Percentage of Participants With ≥1 Adverse Event (AE) [ Time Frame: Up to 24 weeks ]
  • Percentage of Participants With a Grade 3 or 4 AE [ Time Frame: Up to 24 weeks ]
  • Percentage of Participants With Events of Death [ Time Frame: Up to 24 weeks ]
  • Percentage of Participants Discontinuing From Study Intervention Due to an AE [ Time Frame: Up to 24 weeks ]
  • Percentage of Participants Discontinuing From Study Intervention Due to a Drug-Related AE [ Time Frame: Up to 24 weeks ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Emory Children's Center ( Site 0103)

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Study Coordinator

404-727-5642

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-07-08.