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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 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Study Design:

observational

Studietyp

Observationell

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

patients

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Tidsperspektiv: Retrospektiv

Kohorter och interventioner

Grupp / Kohort
HIV-behandling

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in log10 Viral Load From Baseline to Last Visit
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
Participants with a history of therapy with antiretroviral medication.
Baseline
Course of Absolute CD4+ Cell Count
Tidsram: 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
Tidsram: Up to 185 months
Number of participants with drug related Adverse Events (AEs)
Up to 185 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2009

Primärt slutförande (Faktisk)

1 november 2010

Studieregistreringsdatum

Först inskickad

16 september 2009

Först inskickad som uppfyllde QC-kriterierna

17 september 2009

Första postat (Uppskatta)

18 september 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

30 juni 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 juni 2014

Senast verifierad

1 juni 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1100.1535

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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