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En roll-over-studie med rilpivirin for humant immunsviktvirus type 1 (HIV-1) infiserte deltakere som deltok i rilpivirin pediatriske studier

2. november 2026 oppdatert av: Janssen Sciences Ireland UC

En åpen-label, roll-over-studie med rilpivirin i kombinasjon med et bakgrunnsregime som inneholder andre antiretrovirale midler (ARV) i humant immunsviktvirus type 1 (HIV-1) infiserte personer som deltok i rilpivirin pediatriske studier

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

48

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Portugal
      • Porto, Portugal
  • Spania
      • Esplugues de Llobregat, Spania
  • Sør-Afrika
      • Bloemfontein, Sør-Afrika
      • Dundee, Sør-Afrika
  • Thailand
      • Bangkok, Thailand
      • Nonthaburi, Thailand
  • Uganda
      • Entebbe, Uganda
      • Kampala, Uganda

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 sekund og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Rilpivirine

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).
Legemiddel: Rilpivirine

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.

Andre navn:
  • TMC278, R278474

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with adverse events (AEs) related to rilpivirine (RPV)
Tidsramme: Up to 32 Days from the last dose administered (Approximately 16 years)

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

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

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

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

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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Sciences Ireland UC

Etterforskere

  • Studieleder: Janssen R&D Ireland Clinical Trials, Janssen R&D Ireland

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. juli 2015

Primær fullføring (Faktiske)

18. august 2026

Studiet fullført (Faktiske)

18. august 2026

Datoer for studieregistrering

Først innsendt

8. juli 2015

Først innsendt som oppfylte QC-kriteriene

8. juli 2015

Først lagt ut (Antatt)

13. juli 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR107451
  • 2014 (U.S. NIH-stipend/kontrakt)
  • TMC278IFD3004 (Annen identifikator: Janssen Research & Development, LLC)
  • 2014-002471-28 (EudraCT-nummer)
  • 2024-512889-33-00 (Registeridentifikator: EUCT number)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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