NCT02494986

A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies

An Open-label, Roll-over Study With Rilpivirine in Combination With a Background Regimen Containing Other Antiretrovirals (ARVs) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Who Participated in Rilpivirine Pediatric Studies

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Janssen Sciences Ireland UC · Industry
• Sex: All
• Age: 0 Days
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide continued access to rilpivirine (RPV) for participants who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from RPV treatment.

Detailed description

This is an open-label (all people know the identity of the intervention), multicenter (more than one hospital or clinical site work on a study), roll-over study to provide continued access to RPV for human immunodeficiency virus type 1 (HIV-1) infected participants. All enrolled participants will continue to receive RPV in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs). Participants will continue to receive RPV in this study until one of the following criteria is met (whichever comes first) as determined in the study protocol: they meet at least one of the withdrawal criteria, or the participant has been treated in this roll-over study for 4 years (48 months) or older than 12 years of age and can continue RPV treatment outside of this roll-over study by switching to locally available RPV (if commercially available and reimbursed, or accessible through another source \[example: access program or government program\]) or other locally available RPV-based regimens.

Conditions

• Human Immunodeficiency Virus Type 1

Interventions

Type	Name	Description
DRUG	Rilpivirine	Participants will continue to receive oral tablets of rilpivirine (RPV) 25 milligram once daily (mg qd) or a weight-adjusted dose, in combination with an investigator selected background regimen consisting of other ARVs.

Timeline

• Start date: 2015-07-06
• Primary completion: 2026-08-18
• Completion: 2027-06-30
• First posted: 2015-07-13
• Last updated: 2026-04-13

Locations

8 sites across 5 countries: Portugal, South Africa, Spain, Thailand, Uganda