Clinical trial NCT02494986: A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Human Immunodeficiency Virus Type 1
Keywords: Human immunodeficiency virus type 1
Rilpivirine
Roll-over study
Pediatrics
Lead sponsor: Janssen Sciences Ireland UC
Sponsor class: INDUSTRY
First posted: 2015-07-13
Enrollment: 48
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participants using disallowed concomitant treatment
* 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)
* 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

Primary outcomes:
measure: Number of participants with adverse events (AEs) related to rilpivirine (RPV)
timeFrame: Up to 32 Days from the last dose administered (Approximately 16 years)
measure: Number of Participants with AEs Leading to Discontinuation
timeFrame: Up to 32 Days from the last dose administered (Approximately 16 years)
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 32 Days from the last dose administered (Approximately 16 years)
measure: Number of Participants with Pregnancies
timeFrame: Up to 32 Days from the last dose of administered (Approximately 16 years)
measure: Number or Participants with Grade 3/4 Rash Regardless of Causality
timeFrame: Up to 32 Days from the last dose administered (Approximately 16 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
city: Bloemfontein
country: South Africa
city: Dundee
country: South Africa
city: Esplugues De Llobregat
country: Spain
city: Bangkok
country: Thailand
city: Nonthaburi
country: Thailand
city: Entebbe
country: Uganda
city: Kampala
country: Uganda
Study officials:
affiliation: Janssen R&D Ireland
name: Janssen R&D Ireland Clinical Trials
role: STUDY_DIRECTOR
References: