A roll-over study with rilpivirine for human immunodeficiency virus type 1 (HIV-1) infected subjects who participated in rilpivirine pediatric studies.

2024-512889-33-00 Therapeutic exploratory (Phase II) Ongoing, recruitment ended

Start 30 Jan 2021 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruitment ended
Participants planned 43
Countries 1
Sites 2

HIV-1 Infection

The primary objective is to provide continued access to RPV for subjects 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.

Key facts

Sponsor
Janssen Sciences Ireland Unlimited Company
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Virus Diseases [C02]
Trial duration
30 Jan 2021 → ongoing
Decision date (initial)
2024-08-12
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-512889-33-00
EudraCT number
2014-002471-28

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy, Others

The primary objective is to provide continued access to RPV for subjects 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 and MedDRA coding

HIV-1 Infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. 1. Subjects (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).
  2. 2. Subjects must be HIV-1 infected and must have previously been treated with RPV 25 mg qd (or weight-adjusted dose) in a clinical development pediatric study and completed the protocol-defined treatment period.
  3. 3. Subjects 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 subject 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.
  4. 4. Subjects must be able and willing to comply with the current protocol requirements.
  5. 5. Subjects’ general medical condition, in the opinion of the investigator, does not interfere with participation in this study.

Exclusion criteria 4

  1. 1. Subjects using disallowed concomitant treatment.
  2. 2. Pregnant subjects.
  3. 3. Female subjects of childbearing potential and non-vasectomized heterosexually active male subjects not willing to continue practicing birth control methods during the study and for ≥1 month after the end of the study.
  4. 4. Subjects 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. No primary endpoint is defined for this study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

—

SCP265346 · ATC

Route of administration
ORAL USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Authorised
ATC code
J05AG05 — RILPIVIRINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

JNJ-16150108

PRD11242393 · Product

Active substance
Rilpivirine
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
120 Month(s)
Authorisation status
Not Authorised
MA holder
JANSSEN SCIENCES IRELAND UC
Paediatric formulation
Yes
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Sciences Ireland Unlimited Company

Sponsor organisation
Janssen Sciences Ireland Unlimited Company
Address
Barnahely
City
Ringaskiddy
Postcode
P43 FA46
Country
Ireland

Scientific contact point

Organisation
Janssen Sciences Ireland Unlimited Company
Contact name
CTIS Point of Contact

Public contact point

Organisation
Janssen Sciences Ireland Unlimited Company
Contact name
CTIS Point of Contact

Third parties 1

OrganisationCity, countryDuties
IQVIA RDS (India) Private Limited
ORG-100047036
 Mumbai, India Data management

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ongoing, recruitment ended 3 2
Rest of world
Thailand, Uganda, South Africa
 — 40 —

Investigational sites

Italy

2 sites · Ongoing, recruitment ended
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento di Scienze Mediche Traslazionali Malattie Infettive Pediatriche, Via Sergio Pansini 5, 80131, Naples
Bambino Gesu Childrens Hospital
Immunoinfettivologia Pediatrica, Piazza Sant'Onofrio 4, 00165, Rome

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2021-01-30 2021-01-30 2022-03-30

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) REDACTED_D1_Protocol 2024-512889-33 Am2-EEA1
Recruitment arrangements (for publication) PLACEHOLDER_K1_Recruitment Arrangements_IT_ENG_2024-512889-33 1
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Letter to Partner_IT_ITA_2024-512889-33 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master Assent Adolescent_IT_ITA_2024-512889-33 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master Assent Child_IT_ITA_2024-512889-33 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Master Parent Guardian_IT_ITA_2024-512889-33 4
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Privacy Appendix Parent Guardian_IT_ITA_2024-512889-33 2
Subject information and informed consent form (for publication) REDACTED_L1_SIS and ICF Withdrawal Parent Guardian_IT_ITA_2024-512889-33 1
Subject information and informed consent form (for publication) REDACTED_L2_Subject Wallet Card_IT_ITA_2024-512889-33 1
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC Edurant NA
Synopsis of the protocol (for publication) REDACTED_D1_Protocol Synopsis_IT_ITA_2024-512889-33 Am2 EEA-1

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-12 Italy Acceptable
2024-06-25
 2024-08-12
2 SUBSTANTIAL MODIFICATION SM-1 2024-11-27 Italy Acceptable
2025-01-23
 2025-02-12
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-07-15 Italy Acceptable
2025-01-23
 2025-07-15

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