Last updated on February 2018

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 1 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 they no longer benefit from RPV treatment, they meet at least 1 of the withdrawal criteria, or RPV is licensed for adult/pediatric use (depending on the age of the participant) and/or is available/accessible outside of a clinical study setting, whichever comes first.

Clinical Study Identifier: NCT02494986

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Josha Research
Bloemfontein, South Africa
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Jan Fourie Medical Practice
Dundee, South Africa
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