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

NCT02494986 | Active Not Recruiting Phase 2

• 4 other identifiers: CR107451TMC278IFD30042014-002471-282024-512889-33-00
• Study Type: interventional
• Target: 48
• Locations: 5 countries
• Sites: 8

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.

Conditions

Human Immunodeficiency Virus Type 1

Keywords

Human immunodeficiency virus type 1; Rilpivirine; Roll-over study; Pediatrics

Outcome Measures

Primary Outcomes (5)

• 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.

  Up to 32 Days from the last dose administered (Approximately 16 years)

• 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.

  Up to 32 Days from the last dose administered (Approximately 16 years)

• 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.

  Up to 32 Days from the last dose administered (Approximately 16 years)

• Number of Participants with Pregnancies

  Number of participants with pregnancies will be reported.

  Up to 32 Days from the last dose of administered (Approximately 16 years)

• 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.

  Up to 32 Days from the last dose administered (Approximately 16 years)

Study Arms (1)

Rilpivirine

EXPERIMENTAL

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).

Drug: Rilpivirine

Interventions

Rilpivirine DRUG

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.

Also known as: TMC278, R278474

Rilpivirine

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (8)

Unknown Facility

Porto, Portugal

Location

Unknown Facility

Bloemfontein, South Africa

Location

Unknown Facility

Dundee, South Africa

Location

Unknown Facility

Esplugues de Llobregat, Spain

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Nonthaburi, Thailand

Location

Unknown Facility

Entebbe, Uganda

Location

Unknown Facility

Kampala, Uganda

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Rilpivirine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen R&D Ireland Clinical Trials

  Janssen R&D Ireland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 13, 2015
• Study Start: July 6, 2015
• Primary Completion (Estimated): August 18, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Locations

PT (1); ZA (2); ES (1); TH (2); UG (2)