A Clinical Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 years) who are Virologically Suppressed

Phase 1

Conditions: HIV-1 Infection
MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2018-004301-32-RO

Lead Sponsor: Janssen Sciences Ireland UC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1.Aged =2 to <12 years at screening.
2.Weighing at least 11 kg at screening.
3.Have documented chronic HIV-1 infection.
4.On a stable ARV regimen for at least 6 months prior to screening and virologically suppressed, with documents evidence of at least 2 plasma viral loads <50 HIV-1 RNA copies/mL: one within 2-12 months prior to screening and one at screening.
5. Criterion deleted
6. Parent(s) (preferably both if available per local requirements) or the participant's legally acceptable representative[s]) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study. Assent is also required from participants capable of understanding the nature of the study (typically aged = 7 years)
7.Can comply with the protocol requirements.
8.Can switch from any ARV class.
9.Never been treated with a therapeutic HIV vaccine.
10.Otherwise healthy and medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant’s source documents and initialed by the investigator.

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

Any potential participant who meets any of the following criteria will be excluded from participating in the study:
1. Have previously documented HIV-2 infection.
2. Have known or suspected acute (primary) HIV-1 infection.
3. Taken any disallowed concomitant therapies within 4 weeks before the planned first dose of study intervention.
4. A positive HLA-B*5701 test at screening (when the investigator considers ABC in the background regimen). In case of a positive test, ABC cannot be administered, but instead, the investigator can select another ARV in the background regimen.
HLA-B*5701 testing is not required for participants with prior documented negative results.
5. Any current or history of adrenal disorder.
6. Any active clinically significant diseases (eg, pancreatitis, cardiac dysfunction, active and significant psychiatric disorders, clinical suspicion of adrenal insufficiency, and hepatic impairment) or findings at screening or medical history that, in the investigator’s opinion, would compromise the outcome of the study.
7. A history of virologic failure to ARVs with or without availability of an HIV-1 genotype result at the time of failure.
8. Documented genotypic evidence of resistance to RPV or to the selected background ARVs from historical data available in the source documents.
9. A known clinically significant allergy, hypersensitivity, or intolerance to RPV or its excipients or to the selected background ARVs.
10. Criterion modified per Amendment 1
10.1 Received an investigational intervention (including investigational vaccines) containing an active substance or used an invasive investigational medical device within 90 days before the planned first dose of study intervention.

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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