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Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

27. juni 2014 opdateret af: Boehringer Ingelheim
The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). An observation period of about 10 years extends far beyond the duration of clinical trials. First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Study Design:

observational

Undersøgelsestype

Observationel

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Aachen, Tyskland
        • Boehringer Ingelheim Investigational Site 1
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 10
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 11
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 14
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 4
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 5
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 8
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 9
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 12
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 13
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 15
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 2
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 3
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 6
      • Berlin, Tyskland
        • Boehringer Ingelheim Investigational Site 7
      • Bochum, Tyskland
        • Boehringer Ingelheim Investigational Site 16
      • Bonn, Tyskland
        • Boehringer Ingelheim Investigational Site 17
      • Bremen, Tyskland
        • Boehringer Ingelheim Investigational Site 18
      • Dortmund, Tyskland
        • Boehringer Ingelheim Investigational Site 19
      • Duisburg, Tyskland
        • Boehringer Ingelheim Investigational Site 20
      • Düsseldorf, Tyskland
        • Boehringer Ingelheim Investigational Site 21
      • Düsseldorf, Tyskland
        • Boehringer Ingelheim Investigational Site 22
      • Düsseldorf, Tyskland
        • Boehringer Ingelheim Investigational Site 23
      • Düsseldorf, Tyskland
        • Boehringer Ingelheim Investigational Site 24
      • Frankfurt, Tyskland
        • Boehringer Ingelheim Investigational Site 25
      • Frankfurt, Tyskland
        • Boehringer Ingelheim Investigational Site 26
      • Frankfurt, Tyskland
        • Boehringer Ingelheim Investigational Site 27
      • Freiburg, Tyskland
        • Boehringer Ingelheim Investigational Site 28
      • Freiburg, Tyskland
        • Boehringer Ingelheim Investigational Site 29
      • Freiburg, Tyskland
        • Boehringer Ingelheim Investigational Site 30
      • Hamburg, Tyskland
        • Boehringer Ingelheim Investigational Site 31
      • Hamburg, Tyskland
        • Boehringer Ingelheim Investigational Site 32
      • Hamburg, Tyskland
        • Boehringer Ingelheim Investigational Site 33
      • Hamburg, Tyskland
        • Boehringer Ingelheim Investigational Site 34
      • Hamburg, Tyskland
        • Boehringer Ingelheim Investigational Site 35
      • Hamburg, Tyskland
        • Boehringer Ingelheim Investigational Site 36
      • Hannover, Tyskland
        • Boehringer Ingelheim Investigational Site 37
      • Hannover, Tyskland
        • Boehringer Ingelheim Investigational Site 38
      • Hannover, Tyskland
        • Boehringer Ingelheim Investigational Site 39
      • Heidelberg, Tyskland
        • Boehringer Ingelheim Investigational Site 40
      • Karlsruhe, Tyskland
        • Boehringer Ingelheim Investigational Site 41
      • Koblenz, Tyskland
        • Boehringer Ingelheim Investigational Site 42
      • Leipzig, Tyskland
        • Boehringer Ingelheim Investigational Site 43
      • Mannheim, Tyskland
        • Boehringer Ingelheim Investigational Site 44
      • Mannheim, Tyskland
        • Boehringer Ingelheim Investigational Site 45
      • München, Tyskland
        • Boehringer Ingelheim Investigational Site 46
      • München, Tyskland
        • Boehringer Ingelheim Investigational Site 47
      • München, Tyskland
        • Boehringer Ingelheim Investigational Site 48
      • München, Tyskland
        • Boehringer Ingelheim Investigational Site 49
      • München, Tyskland
        • Boehringer Ingelheim Investigational Site 50
      • Münster, Tyskland
        • Boehringer Ingelheim Investigational Site 51
      • Münster, Tyskland
        • Boehringer Ingelheim Investigational Site 52
      • Münster, Tyskland
        • Boehringer Ingelheim Investigational Site 53
      • Oldenburg, Tyskland
        • Boehringer Ingelheim Investigational Site 54
      • Osnabrück, Tyskland
        • Boehringer Ingelheim Investigational Site 55
      • Saarbrücken, Tyskland
        • Boehringer Ingelheim Investigational Site 56
      • Stuttgart, Tyskland
        • Boehringer Ingelheim Investigational Site 57
      • Stuttgart, Tyskland
        • Boehringer Ingelheim Investigational Site 58
      • Stuttgart, Tyskland
        • Boehringer Ingelheim Investigational Site 59
      • Wuppertal, Tyskland
        • Boehringer Ingelheim Investigational Site 60

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patients

Beskrivelse

Inclusion criteria The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843)

Exclusion criteria The exclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
HIV behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in log10 Viral Load From Baseline to Last Visit
Tidsramme: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
Tidsramme: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
Tidsramme: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
Tidsramme: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade
Tidsramme: Up to 185 months
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Up to 185 months
Duration of Intake of Viramune
Tidsramme: End of treatment, up to 185 months
Duration of intake of Viramune
End of treatment, up to 185 months
History of Therapy With Antiretroviral Medication
Tidsramme: Baseline
Participants with a history of therapy with antiretroviral medication.
Baseline
Course of Absolute CD4+ Cell Count
Tidsramme: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.
Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
Number of Participants With Drug Related Adverse Events
Tidsramme: Up to 185 months
Number of participants with drug related Adverse Events (AEs)
Up to 185 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2009

Primær færdiggørelse (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

16. september 2009

Først indsendt, der opfyldte QC-kriterier

17. september 2009

Først opslået (Skøn)

18. september 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1100.1535

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektioner

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Sponsorer og samarbejdspartnere

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CROs by country

CROs in Austria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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