Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
Completed · Phase 2
Conditions studied: HIV-1 Infection
In brief
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric participants who are virologically suppressed (VS) on antiretroviral therapy (ART) for ≥3 months or are treatment-naive (TN). The primary purposes of the study are 1) to examine the steady-state pharmacokinetics (PK) of ISL in plasma; 2) the steady-state PK of ISL-triphosphate (ISL-TP) in peripheral blood mononuclear cells (PBMCs); and 3) to examine the safety and tolerability of ISL/DOR.
Key facts
- Study ID
- NCT04295772
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 42
- Starts
- 2020-11-26
- Expected to finish
- 2023-01-25
- Last updated by the study team
- 2024-01-31
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Is HIV-1 positive, is <18 years of age, and weighs ≥35 kg at screening.
- VS Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA <50 copies/mL and has been receiving continuous, stable oral 2-drug or 3-drug combination ART ± PK booster with documented viral suppression for ≥3 months prior to providing documented informed consent/assent and has no history of prior virologic treatment failure on any past or current regimen.
- TN Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA ≥500 copies/mL and is naive to ART defined as having received <=10 days of prior therapy with any antiretrovirals following HIV-1 diagnosis other than pre-exposure prophylaxis (PrEP) or potentially exposed person (PEP).
- If female, is not pregnant or breastfeeding, and is either 1) not a woman of childbearing potential (WOCBP) or 2) is a WOCBP and is using acceptable contraception or is abstinent.
You may not qualify if…
- Has HIV-2 infection.
- Has hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator.
- Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive).
- Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma.
- Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate.
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 45 days prior to Day 1 through the study treatment period.
- Is currently taking long-acting cabotegravir-rilpivirine.
- 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 study treatment period.
- Has a documented or known virologic resistance to DOR/ISL (DOR resistance substitutions in reverse transcriptase: V106A/M, V108I, Y188L, H221Y, P225H, F227C/L, M230I/L, L234I, P236L, or Y318F; ISL resistance substitution in reverse transcriptase: M184V/I).
- Has exclusionary laboratory values.
- Is female and expecting to conceive or donate eggs at any time during the study.
Where it is running
- Children's National Medical Center ( Site 1816) — Washington D.C., District of Columbia, United States
- Emory Children's Center ( Site 1805) — Atlanta, Georgia, United States
- Johns Hopkins University ( Site 1800) — Baltimore, Maryland, United States
- Duke University ( Site 1807) — Durham, North Carolina, United States
- Azienda Ospedaliera Luigi Sacco ( Site 1300) — Milan, Italy
- IRCCS Ospedale Pediatrico Bambino Gesu ( Site 1301) — Roma, Italy
- Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1507) — Krasnoyarsk, Krasnoyarsk Krai, Russia
- Infectious Clinical Hospital #2 ( Site 1501) — Moscow, Moscow, Russia
- FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1500) — Saint Petersburg, Sankt-Peterburg, Russia
- Saratov Regional Clinical Center for Prophylaxis and Control of AIDS ( Site 1505) — Saratov, Saratov Oblast, Russia
- Perinatal HIV Research Unit ( Site 1902) — Johannesburg, Gauteng, South Africa
- Wits Reproductive Health and HIV Institute (WRHI) ( Site 1903) — Johannesburg, Gauteng, South Africa
- Empilweni Services and Research Unit ( Site 1904) — Johannesburg, Gauteng, South Africa
- King Edward Hospital ( Site 1900) — Durban, KwaZulu-Natal, South Africa
- Chulalongkorn University ( Site 1602) — Bangkok, Bangkok, Thailand
- Siriraj Hospital ( Site 1601) — Bangkok, Bangkok, Thailand
- Research Institute for Health Sciences ( Site 1603) — Chiang Mai, Thailand
Full record on ClinicalTrials.gov
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