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-ES
• Lead Sponsor: Janssen Sciences Ireland UC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 9 May 2022

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.Criterion modified per Amendment 1
4.1 Virologically suppressed on a stable ARV regimen with documented 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
Note: single viral loads =50 HIV-1 RNA copies/mL (‘blips’) are allowed after viral suppression (confirmed viral load <50 HIV-1 RNA copies/mL) within 12 months prior to screening, provided a subsequent viral load measurement is <50 HIV-1 RNA copies/mL (or HIV-1 RNA undetectable by a local HIV-1 RNA test) prior to or at screening.
5.Criterion deleted per Amendment 1.
6.Parent(s) (preferably both if available or as 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 and is willing to allow the child to participate in the study. Assent is also required from participants capable of understanding the nature of the study (typically aged =7 years), as described in the Informed Consent Process in Section 10.3, Appendix 3, Regulatory, Ethical, and Study Oversight Considerations.
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 (ie,at least 1NNRTI RAM from the following list compiled on the basis of the list of the International Antiviral Society United States of America [IAS-USA] NNRTI RAMs and other relevant publications).
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