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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2034-04-11

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Human Immunodeficiency Virus (HIV) Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Doravirine

Intervention Type DRUG

Administered orally

2 NRTIs

Intervention Type DRUG

Administered orally

DOR/3TC/TDF

Intervention Type DRUG

Administered orally

Interventions

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Doravirine

Administered orally

Intervention Type DRUG

2 NRTIs

Administered orally

Intervention Type DRUG

DOR/3TC/TDF

Administered orally

Intervention Type DRUG

Other Intervention Names

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MK-1439 MK-1439A

Eligibility Criteria

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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

* 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

Minimum Eligible Age

4 Weeks

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Khon Kaen, , Thailand

Site Status RECRUITING

Countries

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United States Colombia Mexico Russia South Africa Thailand

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]

1-888-577-8839

Review additional registry numbers or institutional identifiers associated with this trial.

MK-1439-066

Identifier Type: OTHER

Identifier Source: secondary_id

2019-003955-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1439-066

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

DORA: A Doravirine-based First-line Antiretroviral Therapy for Women of Reproductive Potential Living With HIV

DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)

DORAvirine Versus DOlutegravir Based Antiretroviral Regimens in Treatment-naïve People Living With HIV-1 Infection

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/

Detailed Description

Conditions

Study Design

Study Groups

Doravirine as a single entity plus 2 NRTIs or Doravirine as a FDC with 3TC and TDF

Doravirine

2 NRTIs

DOR/3TC/TDF

Interventions

Doravirine

2 NRTIs

DOR/3TC/TDF

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Merck Sharp & Dohme LLC

Responsible Party

Principal Investigators

Medical Director

Locations

University of Colorado at Denver ( Site 0108)

Emory Children's Center ( Site 0103)

Clinica Somer ( Site 1003)

Ciensalud Ips S A S ( Site 1001)

CEIP - Centro de Estudios en Infectología Pediátrica ( Site 1002)

Hospital Infantil de Mexico Federico Gomez ( Site 0702)

Unidad de Atencion Medica e Investigacion en Salud S.C. ( Site 0700)

Instituto Nacional de Pediatria ( Site 0701)

Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 0506)

Clinical Centre for Prevention and Control of AIDS ( Site 0504)

Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 0507)

Infectious Clinical Hospital #2 ( Site 0501)

FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 0500)

FARMOVS PTY LTD ( Site 0601)

Perinatal HIV Research Unit ( Site 0602)

Wits Reproductive Health and HIV Institute (WRHI) ( Site 0603)

Empilweni Services and Research Unit ( Site 0604)

King Edward Hospital ( Site 0600)

Family Clinic Research With UBUNTU ( Site 0605)

Be Part Yoluntu Centre ( Site 0606)

Tsitsikamma Clinical Research Initiative (TCRI) ( Site 0607)

Siriraj Hospital ( Site 0901)

Research Institute for Health Sciences ( Site 0902)

Faculty of Medicine - Khon Kaen University ( Site 0903)

Countries

Central Contacts

Toll Free Number

Facility Contacts

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Study Coordinator

Related Links

Other Identifiers

MK-1439-066

2019-003955-13

1439-066

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