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

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling

Phase 2

Conditions

Human Immunodeficiency Virus (HIV) Infection

Treatments

Drug: 2 NRTIs

Drug: Doravirine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04375800

1439-066

MK-1439-066 (Other Identifier)

2019-003955-13 (EudraCT Number)

Details and patient eligibility

About

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 first primary objective is 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. The second primary objective is 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.

Full description

Participants who complete the Week 96 visit will be eligible to enroll in an Extension Study in which they may continue to receive DOR until it is commercially available, or for up to an additional 224 weeks (whichever comes first).

Enrollment

84 estimated patients

Sex

All

Ages

4 weeks to 11 years old

Volunteers

No Healthy Volunteers

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 selected by the investigator.
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 plus 2 NRTIs selected by the investigator until DOR is available commercially 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