Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
16. november 2011 oppdatert av: Abbott
The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
33
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Berlin, Tyskland, 10243
- Site Reference ID/Investigator# 27575
-
Berlin, Tyskland, 10961
- Site Reference ID/Investigator# 27592
-
Dortmund, Tyskland, 44137
- Site Reference ID/Investigator# 27588
-
Frankfurt, Tyskland, 60311
- Site Reference ID/Investigator# 27583
-
Frankfurt, Tyskland, 60596
- Site Reference ID/Investigator# 27587
-
Hamburg, Tyskland, 20099
- Site Reference ID/Investigator# 27607
-
Krefeld, Tyskland, 47800
- Site Reference ID/Investigator# 5355
-
Muenster, Tyskland, 48149
- Site Reference ID/Investigator# 27604
-
-
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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections
Beskrivelse
Inclusion Criteria:
- Patients infected by HIV-1 and HBV or HCV
- Age ≥18 years
- Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen
Exclusion Criteria:
- Contraindications as described in SmPC (summary of product characteristics) at the time of prescription
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 |
|---|---|
|
HIV-infected patients with hepatitis co-infection
HIV-infected patients with co-infections of Hepatitis B or Hepatitis C
|
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Baseline
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Baseline are presented.
|
Baseline
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 4
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 4 are presented.
|
Week 4
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 12
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 12 are presented.
|
Week 12
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 24
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 24 are presented.
|
Week 24
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 36
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 36 are presented.
|
Week 36
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 48
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 48 are presented.
|
Week 48
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 60
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 60 are presented.
|
Week 60
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 72
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 72 are presented.
|
Week 72
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 84
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 84 are presented.
|
Week 84
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 96
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 96 are presented.
|
Week 96
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 108
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 108 are presented.
|
Week 108
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 120
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 120 are presented.
|
Week 120
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 132
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 132 are presented.
|
Week 132
|
|
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Tidsramme: Week 144
|
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 144 are presented.
|
Week 144
|
|
Viral Load
Tidsramme: Baseline
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Baseline are presented.
|
Baseline
|
|
Viral Load
Tidsramme: Week 4
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 4 are presented.
|
Week 4
|
|
Viral Load
Tidsramme: Week 12
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 12 are presented.
|
Week 12
|
|
Viral Load
Tidsramme: Week 24
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 24 are presented.
|
Week 24
|
|
Viral Load
Tidsramme: Week 36
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 36 are presented.
|
Week 36
|
|
Viral Load
Tidsramme: Week 48
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 48 are presented.
|
Week 48
|
|
Viral Load
Tidsramme: Week 60
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 60 are presented.
|
Week 60
|
|
Viral Load
Tidsramme: Week 72
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 72 are presented.
|
Week 72
|
|
Viral Load
Tidsramme: Week 84
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 84 are presented.
|
Week 84
|
|
Viral Load
Tidsramme: Week 96
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 96 are presented.
|
Week 96
|
|
Viral Load
Tidsramme: Week 108
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 108 are presented.
|
Week 108
|
|
Viral Load
Tidsramme: Week 120
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 120 are presented.
|
Week 120
|
|
Viral Load
Tidsramme: Week 132
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 132 are presented.
|
Week 132
|
|
Viral Load
Tidsramme: Week 144
|
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment.
The mean values and standard deviations for those tested at Week 144 are presented.
|
Week 144
|
|
CD4 Cell Count
Tidsramme: Baseline
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Baseline are presented.
|
Baseline
|
|
CD4 Cell Count
Tidsramme: Week 4
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 4 are presented.
|
Week 4
|
|
CD4 Cell Count
Tidsramme: Week 12
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 12 are presented.
|
Week 12
|
|
CD4 Cell Count
Tidsramme: Week 24
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 24 are presented.
|
Week 24
|
|
CD4 Cell Count
Tidsramme: Week 36
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 36 are presented.
|
Week 36
|
|
CD4 Cell Count
Tidsramme: Week 48
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 48 are presented.
|
Week 48
|
|
CD4 Cell Count
Tidsramme: Week 60
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 60 are presented.
|
Week 60
|
|
CD4 Cell Count
Tidsramme: Week 72
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 72 are presented.
|
Week 72
|
|
CD4 Cell Count
Tidsramme: Week 84
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 84 are presented.
|
Week 84
|
|
CD4 Cell Count
Tidsramme: Week 96
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 96 are presented.
|
Week 96
|
|
CD4 Cell Count
Tidsramme: Week 108
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 108 are presented.
|
Week 108
|
|
CD4 Cell Count
Tidsramme: Week 120
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 120 are presented.
|
Week 120
|
|
CD4 Cell Count
Tidsramme: Week 132
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 132 are presented.
|
Week 132
|
|
CD4 Cell Count
Tidsramme: Week 144
|
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment.
The mean and standard deviation for those tested at Week 144 are presented.
|
Week 144
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. mai 2001
Primær fullføring (Faktiske)
1. november 2010
Studiet fullført (Faktiske)
1. november 2010
Datoer for studieregistrering
Først innsendt
26. februar 2010
Først innsendt som oppfylte QC-kriteriene
28. juni 2010
Først lagt ut (Anslag)
30. juni 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. desember 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. november 2011
Sist bekreftet
1. november 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Sykdommer i immunsystemet
- Leversykdommer
- Langsomme virussykdommer
- HIV-infeksjoner
- Hepatitt
- Ervervet immunsviktsyndrom
- Immunologiske mangelsyndromer
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Proteasehemmere
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- HIV-proteasehemmere
- Virale proteasehemmere
- Ritonavir
- Lopinavir
Andre studie-ID-numre
- KAL 1 HO
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. .