Back to resultsA Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
Primary Purpose
Human Immunodeficiency Virus Type 1
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rilpivirine
Sponsored by
About this trial
This is an interventional treatment trial for Human Immunodeficiency Virus Type 1 focused on measuring Human immunodeficiency virus type 1, Rilpivirine, Roll-over study, Pediatrics
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- Participants who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rilpivirine
Arm Description
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 antiretrovirals (ARVs).
Outcomes
Primary Outcome Measures
Number of participants with adverse events (AEs) related to rilpivirine (RPV)
Evaluation of long term safety of the treatment with RPV with a background regimen. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants with AEs Leading to Discontinuation
Number of participants with AEs leading to discontinuation will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Participants with Serious Adverse Events (SAEs)
Number of participants with SAEs will be reported. An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Participants with Pregnancies
Number of participants with pregnancies will be reported.
Number or Participants with Grade 3/4 Rash Regardless of Causality
Number of participants with grade 3/4 rash regardless of causality will be reported.
Secondary Outcome Measures
Full Information
NCT ID
NCT02494986
First Posted
July 8, 2015
Last Updated
October 10, 2023
Sponsor
Janssen Sciences Ireland UC
1. Study Identification
Unique Protocol Identification Number
NCT02494986
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Sciences Ireland UC
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus Type 1
Keywords
Human immunodeficiency virus type 1, Rilpivirine, Roll-over study, Pediatrics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rilpivirine
Arm Type
Experimental
Arm Description
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 antiretrovirals (ARVs).
Intervention Type
Drug
Intervention Name(s)
Rilpivirine
Other Intervention Name(s)
TMC278, R278474
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events (AEs) related to rilpivirine (RPV)
Description
Evaluation of long term safety of the treatment with RPV with a background regimen. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Up to 32 Days from the last dose administered (Approximately 16 years)
Title
Number of Participants with AEs Leading to Discontinuation
Description
Number of participants with AEs leading to discontinuation will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time Frame
Up to 32 Days from the last dose administered (Approximately 16 years)
Title
Number of Participants with Serious Adverse Events (SAEs)
Description
Number of participants with SAEs will be reported. An SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
Up to 32 Days from the last dose administered (Approximately 16 years)
Title
Number of Participants with Pregnancies
Description
Number of participants with pregnancies will be reported.
Time Frame
Up to 32 Days from the last dose of administered (Approximately 16 years)
Title
Number or Participants with Grade 3/4 Rash Regardless of Causality
Description
Number of participants with grade 3/4 rash regardless of causality will be reported.
Time Frame
Up to 32 Days from the last dose administered (Approximately 16 years)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen R&D Ireland Clinical Trials
Organizational Affiliation
Janssen R&D Ireland
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Learn more about this trial
A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
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