- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03327740
PRJ2203: Dolutegravir Post Authorization Safety Study (PASS)
5. februar 2020 oppdatert av: ViiV Healthcare
A Prospective Observational Cohort Study to Monitor and Compare the Occurrence of Hypersensitivity Reaction and Hepatotoxicity in Patients Receiving Dolutegravir (With and Without Abacavir) or Other Integrase Inhibitors (With or Without Abacavir)
Dolutegravir (DTG) is recommended for both treatment-naïve and treatment-experienced, HIV infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg.
One case of suspected DTG hypersensitivity (HSR) reaction from among over 1500 subjects exposed to the drug at the time of submission in 4Q2012, has been identified; this subject experienced a diffuse maculopapular rash with fever and elevated liver enzymes.
Isolated rash was uncommon in the DTG programme with less than 1% of clinical trial subjects experiencing treatment related rash.
The pharmacovigilance strategy for DTG and DTG-containing products is to implement a post-marketing risk management program to further quantify the risk of HSR and compare it to that of other integrase inhibitors, and to possibly determine associated risk factors.
In addition, the post-authorization safety study will monitor and compare hepatotoxicity and severe skin rash following initiation of DTG or other integrase inhibitor (raltegravir (RAL) or elvitegravir (EGV) based antiretroviral regimens (ARV).
Further to be able to distinguish the above symptoms and reactions caused by DTG or the other integrase inhibitor regimen from that of abacavir (ABC), known to cause hypersensitivity reaction, the integrase inhibitor groups will be compared in combinations with and without ABC.
This five year-long safety study will be conducted through collaboration with EuroSIDA, a well established prospective observational cohort study of more than 18,200 subjects followed in 107 hospitals in 31 European countries, plus Israel and Argentina.
This is a five year-long non-interventional prospective cohort study nested within the EuroSIDA study.
The study population will include HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or other integrase inhibitors with and without ABC.
Following initiation of DTG with ABC based antiretroviral regimen or DTG without ABC or regimens containing other integrase inhibitors (RAL, EGV) with or without ABC or any other DTG based ARV regimen as monotherapy or two-drug regimens, the study will aim to a) Monitor and compare hypersensitivity reaction, b) Monitor and compare hepatotoxicity, and c) Monitor and compare severe skin rash among all subjects discontinuing DTG or other integrase inhibitor regimens for any reason.
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Forventet)
1
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
17 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
HIV positive subjects over the age of 16 years from EuroSIDA clinical sites, who are new users of DTG or users of other integrase inhibitor regimens (RAL and EGV).
Beskrivelse
Inclusion Criteria:
- New users of DTG or users of other integrase inhibitor regimens (RAL and EGV)
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Subjects on DTG based ARV with ABC
These are subjects who begin a DTG based ARV regimen that includes ABC
|
ARV regimens containing DTG and ABC
|
Subjects that start DTG based ARV regimen but without ABC
These are subjects who begin a DTG-based ARV regimen that does not contain ABC
|
DTG based ARV regimens that do not contain ABC
|
Subjects on other integrase inhibitor based regimen with ABC
These are subjects who begin other integrase inhibitor based regimens (RAL and EGV) that contains ABC
|
RAL or EGV based regimens containing ABC
|
Subjects on other integrase inhibitor based regimen but no ABC
These are subjects that start non-ABC containing RAL or EGV based regimens
|
RAL or EGV based ARV regimens that do not contain ABC
|
Subjects that start any other DTG based ARV regimen
These are subjects who begin any other DTG based ARV regimen that will include DTG as monotherapy or two-drug regimens
|
Any other DTG based ARV regimens including DTG as monotherapy or two-drug regimens.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of subjects with occurrence of hypersensitivity reactions (HSR), of any grade
Tidsramme: Up to 5 years
|
Hypersensitivity reactions including fever, rash, gastrointestinal symptoms, constitutional symptoms, respiratory symptoms and eosinophilia will be summarized.
|
Up to 5 years
|
Number of subjects with hepatic dysfunction
Tidsramme: Up to 5 years
|
Hepatic dysfunction will be indicated by liver chemistry tests
|
Up to 5 years
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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)
30. september 2014
Primær fullføring (Faktiske)
31. desember 2019
Studiet fullført (Faktiske)
31. desember 2019
Datoer for studieregistrering
Først innsendt
27. oktober 2017
Først innsendt som oppfylte QC-kriteriene
27. oktober 2017
Først lagt ut (Faktiske)
31. oktober 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- 201177
- PRJ2203 (Annen identifikator: GSK)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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