Fact CheckerSign in

NCT02494986CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
48 (actual)
First submitted
8 Jul 2015
Start date
6 Jul 2015
Primary completion date
18 Aug 2026
Lead sponsor
Janssen Sciences Ireland UC
Diseases
HIV
NCT number
NCT02494986
EU CT number
2024-512889-33-00
EudraCT number
2014-002471-28

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 48
  • From 6 Jul 2015 to the primary completion date, 18 Aug 2026
  • 10 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants using disallowed concomitant treatment
  • Participants who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria

Other

  • Pregnant participants
  • Female participants of childbearing potential and non-vasectomized heterosexually active male participants not willing to continue practicing birth control methods during the study and for greater than or equal to (≥)1 month after the end of the study (or after last intake of RPV)

Who the study is looking for

  • Participants (or their legally acceptable representative) must sign an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)
  • Participants must be human immunodeficiency virus type 1 (HIV-1) infected and must have previously been treated with rilpivirine (RPV) 25 mg qd (or weight-adjusted dose) in a clinical development pediatric study and completed the protocol-defined treatment period
  • Participants must benefit from treatment with RPV, according to the efficacy and safety criteria as set out in the protocol of the pediatric study with RPV the participant was participating in prior to this rollover study, and must be expected to continue to benefit from this treatment in the opinion of the investigator
  • Participants must be able and willing to comply with the current protocol requirements
  • Participants' general medical condition, in the opinion of the investigator, does not interfere with participation in this study

Age in the registry: 0 days to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
Esplugues de LlobregatSpainUnknown status
Azienda Ospedaliera Universitaria Federico II Di Napoli
Coordinator of this site? Confirm its status
NaplesItalyCompleted
Bambino Gesu Childrens Hospital
Coordinator of this site? Confirm its status
RomeItalyCompleted
-
Coordinator of this site? Confirm its status
PortoPortugalUnknown status
-
Coordinator of this site? Confirm its status
BangkokThailandUnknown status
-
Coordinator of this site? Confirm its status
NonthaburiThailandUnknown status
-
Coordinator of this site? Confirm its status
EntebbeUgandaUnknown status
-
Coordinator of this site? Confirm its status
KampalaUgandaUnknown status
-
Coordinator of this site? Confirm its status
BloemfonteinSouth AfricaUnknown status
-
Coordinator of this site? Confirm its status
DundeeSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.