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

Launched by MERCK SHARP & DOHME LLC · May 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called doravirine (DOR) to see how well it works and how safe it is for children with HIV-1, ages 4 weeks to under 12 years, who weigh less than 45 kg. The trial focuses on children who have never received treatment for HIV or those who have been on stable treatment for at least three months and have no history of treatment failure. The main goals are to understand how the body processes doravirine when taken with other HIV medications and to monitor any side effects over a 24-week period.

To be eligible for the trial, children must have a confirmed HIV-1 infection and meet certain health guidelines, including being between 3 kg and 45 kg in weight. Girls must not be pregnant or breastfeeding, or if they can become pregnant, they need to use contraception. Participants will receive the study medication and will have regular check-ups to assess their health and how the treatment is working. It's important to note that children with certain health conditions, like liver or kidney disease, or other significant medical issues, may not qualify for this study.

Gender

ALL

Eligibility criteria

• 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