Overview

A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

Status:
Recruiting
Trial end date:
2023-02-09
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other antiretrovirals (ARVs) in participants aged greater than or equal to 2 to less than 12 years and to evaluate the safety and tolerability of RPV in combination with other ARVs in participants of same age group over a 48-week treatment period with primary endpoint at Week 24.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Integrase Inhibitors
Rilpivirine
Criteria
Inclusion Criteria:

- Weighing at least 11 kilogram (kg) at screening

- Have documented chronic Human Immunodeficiency Virus (HIV-1) infection

- On a stable antiretroviral (ARV) regimen for at least 6 months prior to screening and
virologically suppressed with documented evidence of at least 2 plasma viral loads
less than (<) 50 HIV-1 ribonucleic acid (RNA) copies/milliliter (mL): one within 2-12
months prior to screening and one at screening

- Can switch from any ARV class

- Never been treated with a therapeutic HIV vaccine

- Historical HIV-1 genotyping result at screening for children aged >=2 to <6 years (and
for children aged >=6 to <12 years if a historical HIV-1 genotyping result is
available at screening) must demonstrate sensitivity to RPV and to the selected
background ARVs

Exclusion Criteria:

- Have previously documented HIV-2 infection

- Have known or suspected acute (primary) HIV-1 infection

- Taken any disallowed concomitant therapies within 4 weeks before the planned first
dose of study intervention

- Any current or history of adrenal disorder

- A history of virologic failure to ARVs with or without availability of an HIV-1
genotype result at the time of failure