Human Immunodeficiency Virus (HIV) InfectionPhase 2NCT04375800
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
A Phase 2 study testing Doravirine, 2 NRTIs and DOR/3TC/TDF in people with Human Immunodeficiency Virus (HIV) Infection, run by Merck Sharp & Dohme LLC at 26 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 weeks to 11 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Infection
- What is being tested?
- Doravirine, 2 NRTIs and DOR/3TC/TDF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 26 sitesin 8 countries
- Study dates
- 3 Feb 2021to 11 Apr 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 8 countries
South Africa8 sites, 5 recruiting
- Completed
FARMOVS PTY LTD ( Site 0601)
Bloemfontein, Free State, 9301
- Recruiting
Family Clinic Research With UBUNTU ( Site 0605)
Cape Town, Western Cape, 7505
Study Coordinator, +27219384153
- Recruiting
King Edward Hospital ( Site 0600)
Durban, KwaZulu-Natal, 4001
Study Coordinator, +27312611093
- Recruiting
Perinatal HIV Research Unit ( Site 0602)
Johannesburg, Gauteng, 1864
Study Coordinator, +2711 989 9700
- Recruiting
Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)
Johannesburg, Gauteng, 2001
Study Coordinator, +27 11 358 5300
- Completed
Empilweni Services and Research Unit ( Site 0604)
Johannesburg, Gauteng, 2093
- Recruiting
Be Part Yoluntu Centre ( Site 0606)
Paarl, Western Cape, 7626
Study Coordinator, +2782 660 5795
- Completed
Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)
Plettenberg Bay, Western Cape, 6600
Russia5 sites
- Active, not recruiting
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)
Kemerovo, Kemerovo Oblast, 650056
- Completed
Clinical Centre for Prevention and Control of AIDS ( Site 0504)
Krasnodar, Krasnodarskiy Kray, 350015
- Completed
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)
Krasnoyarsk, Krasnoyarsk Krai, 660049
- Completed
Infectious Clinical Hospital #2 ( Site 0501)
Moscow, Moscow, 105275
- Active, not recruiting
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)
Saint Petersburg, Sankt-Peterburg, 196645
Colombia3 sites, 2 recruiting
- Recruiting
Ciensalud Ips S A S ( Site 1001)
Barranquilla, Atlántico, 080020
Study Coordinator, 573183894721
- Completed
CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002)
Cali, Valle del Cauca Department, 760042
- Recruiting
Clinica Somer ( Site 1003)
Rionegro, Antioquia, 054040
Study Coordinator, +573235903405
Mexico3 sites
- Completed
Instituto Nacional de Pediatria ( Site 0701)
Coyoacán, Mexico City, 04530
- Completed
Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)
Mérida, Yucatán, 97000
- Active, not recruiting
Hospital Infantil de Mexico Federico Gomez ( Site 0702)
Mexico City, Mexico City, 06720
Thailand3 sites, 3 recruiting
- Recruiting
Siriraj Hospital ( Site 0901)
Bangkok, Bangkok, 10700
Study Coordinator, +6624180545
- Recruiting
Research Institute for Health Sciences ( Site 0902)
Chiang Mai, 50200
Study Coordinator, +6653936148
- Recruiting
Faculty of Medicine - Khon Kaen University ( Site 0903)
Khon Kaen, 40002
Study Coordinator, +66897112236
United States2 sites, 1 recruiting
- Recruiting
Emory Children's Center ( Site 0103)
Atlanta, Georgia, 30322
Study Coordinator, 404-727-5642
- Completed
University of Colorado at Denver ( Site 0108)
Aurora, Colorado, 80045
Dominican Republic1 site, 1 recruiting
- Recruiting
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 1100)
Santo Domingo, 10306
Study Coordinator, +18095703439
Guatemala1 site, 1 recruiting
- Recruiting
Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 1201)
Guatemala City, 01009
Study Coordinator, +50223196600
About this study
Official title: 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
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.
Read the detailed description
Participants who complete the Week 96 visit will be eligible to enroll in an Extension Study and receive DOR until it is commercially available, or for up to an additional 224 weeks (whichever comes first).
- Being tested
- Doravirine, 2 NRTIs, DOR/3TC/TDF
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoravirineDrug
Also called MK-1439
Administered orally
2 NRTIsDrug
Administered orally
DOR/3TC/TDFDrug
Also called MK-1439A
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF | Experimental | 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. Receives: Drug: Doravirine; Drug: 2 NRTIs; Drug: DOR/3TC/TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Per protocol, intensive pharmacokinetic (PK) sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr.
Measured: 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
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax.
Measured: 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
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine C24.
Measured: 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
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Tmax.
Measured: 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
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine AUC0-12hr.
Measured: Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Cmax of DOR Following Twice-Daily Dosing in Plasma at Steady-State
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Cmax.
Measured: 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
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine C12.
Measured: Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Tmax of DOR Following Twice-Daily Dosing in Plasma at Steady-State
Per protocol, intensive PK sampling includes multiple blood samples collected up to 12 hours postdose at a single visit to determine Tmax.
Measured: Intensive pharmacokinetic sampling: at designated timepoints up to 12 hours postdose
Percentage of Participants With ≥1 Adverse Event (AE)
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.
Measured: Up to 24 weeks
Percentage of Participants With a Grade 3 or 4 AE
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).
Measured: Up to 24 weeks
Percentage of Participants With Events of Death
The percentage of participants with events of death at Week 24 will be reported.
Measured: Up to 24 weeks
Percentage of Participants Discontinuing From Study Intervention Due to an AE
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.
Measured: Up to 24 weeks
Percentage of Participants Discontinuing From Study Intervention Due to a Drug-Related AE
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.
Measured: Up to 24 weeks
Secondary outcomes (35)
Plasma Concentration of DOR
Per protocol, sparse PK sampling includes up to 2 blood samples collected at multiple visits up to 24 weeks.
Measured: Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
Plasma Concentration of Lamivudine (3TC) Following Once-Daily Dosing of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) as an Age-Appropriate Fixed-Dose Combination (FDC)
Per protocol, sparse PK sampling includes up to 2 blood samples collected at multiple visits up to 24 weeks.
Measured: Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
Plasma Concentration of Tenofovir (TFV) Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Per protocol, sparse PK sampling includes up to 2 blood samples collected at multiple visits up to 24 weeks.
Measured: Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
AUC0-24hr of 3TC Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr of 3TC.
Measured: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
AUC0-24hr of TFV Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine AUC0-24hr of TFV.
Measured: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Cmax of 3TC Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax of 3TC.
Measured: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Cmax of TFV Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Per protocol, intensive PK sampling includes multiple blood samples collected up to 24 hours postdose at a single visit to determine Cmax of TFV.
Measured: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Percentage of Participants With ≥1 AE at Week 48
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.
Measured: Up to 48 weeks
Percentage of Participants With ≥1 AE at Week 96
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.
Measured: Up to 96 weeks
Percentage of Participants With Grade 3 or 4 AE at Week 48
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).
Measured: Up to 48 weeks
Percentage of Participants With Grade 3 or 4 AE at Week 96
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).
Measured: Up to 96 weeks
Percentage of Participants With Events of Death at Week 48
The percentage of participants with events of death at Week 48 will be reported.
Measured: Up to 48 weeks
Percentage of Participants With Events of Death at Week 96
The percentage of participants with events of death at Week 96 will be reported.
Measured: Up to 96 weeks
Percentage of Participants Discontinuing From Study Intervention Due to AE at Week 48
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.
Measured: Up to 48 weeks
Percentage of Participants Discontinuing from Study Intervention Due to AE at Week 96
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.
Measured: Up to 96 weeks
Percentage of Participants Discontinuing From Study Intervention Due to Drug-Related AE at Week 48
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.
Measured: Up to 48 weeks
Percentage of Participants Discontinuing From Study Intervention Due to Drug-Related AE at Week 96
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.
Measured: Up to 96 weeks
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time polymerase chain reaction (PCR) assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 24 weeks
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 48 weeks
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 96 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 24 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 48 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 96 weeks
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 24 weeks
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 48 weeks
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Up to 96 weeks
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 24
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Baseline (Day 1) and Week 24
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 48
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Baseline (Day 1) and Week 48
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 96
Plasma HIV-1 RNA quantification will be performed at the central laboratory using a real-time PCR assay with a lower limit of detection of 40 copies/mL.
Measured: Baseline (Day 1) and Week 96
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 24
CD4+ T-cell counts will be performed at the central laboratory.
Measured: Baseline (Day 1) and Week 24
Change From Baseline in CD4+ T-Cell Counts at Week 48
CD4+ T-cell counts will be performed at the central laboratory.
Measured: Baseline (Day 1) and Week 48
Change From Baseline in CD4+ T-Cell Counts at Week 96
CD4+ T-cell counts will be performed at the central laboratory.
Measured: Baseline (Day 1) and Week 96
Viral Resistance-Associated Substitutions (RASs) to DOR or Other Treatment Components
The presence of viral RASs to DOR or other treatment components will be monitored for up to 96 weeks.
Measured: Up to 96 weeks
Percentage of Participants Adhering to DOR or to the FDC of DOR/3TC/TDF
Adherence to DOR or to the FDC of DOR/3TC/TDF will be monitored for up to 96 weeks.
Measured: Up to 96 weeks
Assessment of Palatability/Acceptability of Oral Pellets/Granules of DOR or the FDC of DOR/3TC/TDF
Palatability/acceptability will be based on scores on the 5-point facial hedonic scale (FHS). FHS scores will be tabulated and summarized by mean and standard deviation (SD), on Day 28. The highest possible FHS score is 5, with higher scores indicative of greater palatability.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start3 Feb 2021
- Primary completion12 Nov 2028 (estimated)
- Study completion11 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375800
- Sponsor's protocol ID
- 1439-066
- Other IDs
- MK-1439-066, 2019-003955-13, 2019
- Status last verified
- Oct 2026
- First submitted
- 4 May 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04375800
- Acronym / sponsor ID
- 1439-066
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 12 Nov 2028 (estimated)
- Study completion
- 11 Apr 2034 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants who complete the Week 96 visit will be eligible to enroll in an Extension Study and receive DOR until it is commercially available, or for up to an additional 224 weeks (whichever comes first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF | Experimental | Drug: Doravirine, Drug: 2 NRTIs, Drug: DOR/3TC/TDFParticipants 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. |
Who may qualify
- Ages
- 4 weeks to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoravirineAlso: MK-1439Administered orally | Drug | Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF |
| 2 NRTIsAdministered orally | Drug | Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF |
| DOR/3TC/TDFAlso: MK-1439AAdministered orally | Drug | Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF |
Primary outcome
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.
35 secondary outcomes
Plasma Concentration of DOR
Time frame: Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
Plasma Concentration of Lamivudine (3TC) Following Once-Daily Dosing of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) as an Age-Appropriate Fixed-Dose Combination (FDC)
Time frame: Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
Plasma Concentration of Tenofovir (TFV) Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Time frame: Sparse pharmacokinetic sampling: at designated timepoints up to 24 weeks
AUC0-24hr of 3TC Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Time frame: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
AUC0-24hr of TFV Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Time frame: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Cmax of 3TC Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Time frame: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Cmax of TFV Following Once-Daily Dosing of DOR/3TC/TDF as an Age-Appropriate FDC
Time frame: Intensive pharmacokinetic sampling: at designated timepoints up to 24 hours postdose
Percentage of Participants With ≥1 AE at Week 48
Time frame: Up to 48 weeks
Percentage of Participants With ≥1 AE at Week 96
Time frame: Up to 96 weeks
Percentage of Participants With Grade 3 or 4 AE at Week 48
Time frame: Up to 48 weeks
Percentage of Participants With Grade 3 or 4 AE at Week 96
Time frame: Up to 96 weeks
Percentage of Participants With Events of Death at Week 48
Time frame: Up to 48 weeks
Percentage of Participants With Events of Death at Week 96
Time frame: Up to 96 weeks
Percentage of Participants Discontinuing From Study Intervention Due to AE at Week 48
Time frame: Up to 48 weeks
Percentage of Participants Discontinuing from Study Intervention Due to AE at Week 96
Time frame: Up to 96 weeks
Percentage of Participants Discontinuing From Study Intervention Due to Drug-Related AE at Week 48
Time frame: Up to 48 weeks
Percentage of Participants Discontinuing From Study Intervention Due to Drug-Related AE at Week 96
Time frame: Up to 96 weeks
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24
Time frame: Up to 24 weeks
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Time frame: Up to 48 weeks
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Time frame: Up to 96 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 24
Time frame: Up to 24 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48
Time frame: Up to 48 weeks
Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96
Time frame: Up to 96 weeks
Percentage of Participants With HIV-1 RNA ≥50 copies/mL at Week 24
Time frame: Up to 24 weeks
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48
Time frame: Up to 48 weeks
Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
Time frame: Up to 96 weeks
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 24
Time frame: Baseline (Day 1) and Week 24
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 48
Time frame: Baseline (Day 1) and Week 48
Percentage of Participants With Log10 Drop in Plasma HIV-1 RNA From Baseline at Week 96
Time frame: Baseline (Day 1) and Week 96
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-Cell Counts at Week 24
Time frame: Baseline (Day 1) and Week 24
Change From Baseline in CD4+ T-Cell Counts at Week 48
Time frame: Baseline (Day 1) and Week 48
Change From Baseline in CD4+ T-Cell Counts at Week 96
Time frame: Baseline (Day 1) and Week 96
Viral Resistance-Associated Substitutions (RASs) to DOR or Other Treatment Components
Time frame: Up to 96 weeks
Percentage of Participants Adhering to DOR or to the FDC of DOR/3TC/TDF
Time frame: Up to 96 weeks
Assessment of Palatability/Acceptability of Oral Pellets/Granules of DOR or the FDC of DOR/3TC/TDF
Time frame: Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doravirine, 2 NRTIs and DOR/3TC/TDF in people with Human Immunodeficiency Virus (HIV) Infection, run by Merck Sharp & Dohme LLC at 26 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Africa, Russia, Colombia, Mexico, Thailand and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.