DOR/ISL in Adolescents with HIV-1, =12 to <18 years of Age and =35 kg

Phase 1

Conditions: HIV-1 Infection
MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2019-003597-10-Outside-EU/EEA

Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 40

Inclusion Criteria

1. Meets one of the following: a) Virologically Suppressed: Is HIV-1 positive at screening with plasma HIV-1 RNA <50 copies/mL at screening AND Has been receiving continuous, stable oral 2-drug or 3-drug combination ART (± PK booster) with documented viral suppression (HIV-1 RNA <50 copies/mL) 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. OR b) Treatment-Naïve: Is HIV-1 positive with plasma HIV-1 RNA =500 copies/mL at screening AND Is naïve to ART defined as having received =10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection, except for use of PrEP or PEP.
2. Able and willing to swallow available tablet formulation
3. Is male or female <18 years of age and weighing =35 kg at the time of signing the informed consent/assent
4. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: - Is not a WOCBP OR - Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 6 weeks, corresponding to the time needed to eliminate any study intervention(s) (eg, 5 terminal half-lives)] after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention - A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention - If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive - The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy
5. The participant and legally acceptable representative have provided documented informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Has HIV-2 infection
2. Has hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator
3. Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as HBsAg-positive or HBV DNA positive)
4. Has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi’s sarcoma
5. 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
6. 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
7. Is currently taking long-acting cabotegravir-rilpivirine
8. 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
9. Has a documented or known virologic resistance to components of DOR/ISL, as demonstrated by any of the following: - 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
10. Has exclusionary laboratory values (completed by the central laboratory) within 45 days prior to Day 1
11. Is female and expecting to conceive or donate eggs at any time during the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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