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
  • End date
    Feb 9, 2023
  • participants needed
    30
  • sponsor
    Janssen Research & Development, LLC
Updated on 21 April 2021
immunodeficiency
HIV Infection
antiretroviral agents
tenofovir
emtricitabine
dolutegravir
integrase inhibitors
lamivudine
HIV Vaccine
abacavir
raltegravir
rilpivirine

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.

Description

Participants infected with human immunodeficiency virus type 1 (HIV-1) are routinely treated with combinations of multiple drugs which reduces HIV-1 ribonucleic acid (RNA) to undetectable levels in a substantial proportion of participants and counteracts the risk of viral resistance development. RPV is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type (WT) HIV-1 and against NNRTI-resistant HIV-1 mutants. A medical need still exists for the development of age/weight appropriate formulations in children less than (<) 12 years of age. In this study, participants will switch to RPV plus other ARVs. The primary analysis will be performed at Week 24. A participant will be considered to have completed the study if he or she has completed assessments at Week 48 of the study intervention phase. The total study duration for each participant, including screening and study intervention phases, will be approximately 54 weeks. Key efficacy assessments include determination of plasma HIV-1 RNA viral load and measurement of CD4+ cell count. Key safety assessments will include the monitoring of (serious) adverse events ([S]AEs) and HIV-related events, clinical laboratory tests, cardiovascular safety monitoring (vital signs and 12 lead electrocardiogram [ECGs]), and physical examination (including growth).

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment Rilpivirine, ARV Background Regimen
Clinical Study IdentifierNCT04012931
SponsorJanssen Research & Development, LLC
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

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
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