Last updated on November 2019

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

Brief description of study

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 Study Description

This is an open-label (all people know the identity of the intervention), multicenter (more than one hospital or medical school team 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 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs). 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 investigator finds it in the participant's best interest to switch to one of the following options, as appropriate for the participants's age: (1) locally available RPV (ie, commercially available and reimbursed, or accessible through another source [eg, access program or government program]), (2) other local RPV-based regimens, or (3) local standard of care.

Clinical Study Identifier: NCT02494986

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Josha Research

Bloemfontein, South Africa
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