Status:
COMPLETED
A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
HIV
Eligibility:
All Genders
2-11 years
Phase:
PHASE2
Brief 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 parti...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Weighing at least 10 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
- 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
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04012931
Start Date
July 18 2019
End Date
February 23 2023
Last Update
February 4 2025
Active Locations (14)
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1
ASST Spedali Civili di Brescia
Brescia, Italy, 25123
2
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy, 80131
3
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy, 00165
4
Uls Santa Maria - Hosp. Santa Maria
Lisbon, Portugal, 1649 035