Clinical trial NCT00979420: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: treatment experienced
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-09-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients

Brief summary: 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.

Detailed description: Study Design:

observational

Eligibility criteria: 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).

Primary outcomes:
measure: Change in log10 Viral Load From Baseline to Last Visit
timeFrame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
measure: Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
timeFrame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
measure: Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
timeFrame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
measure: Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
timeFrame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Secondary outcomes:
measure: Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
timeFrame: Up to 185 months
measure: Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade
timeFrame: Up to 185 months
measure: Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade
timeFrame: Up to 185 months
measure: Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade
timeFrame: Up to 185 months
measure: Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade
timeFrame: Up to 185 months
measure: Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade
timeFrame: Up to 185 months
measure: Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
timeFrame: Up to 185 months
measure: Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade
timeFrame: Up to 185 months
measure: Duration of Intake of Viramune
timeFrame: End of treatment, up to 185 months
measure: History of Therapy With Antiretroviral Medication
timeFrame: Baseline
measure: Course of Absolute CD4+ Cell Count
timeFrame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
measure: Number of Participants With Drug Related Adverse Events
timeFrame: Up to 185 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 10
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 11
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 12
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 13
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 14
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 15
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 7
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 8
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 9
city: Bochum
country: Germany
facility: Boehringer Ingelheim Investigational Site 16
city: Bonn
country: Germany
facility: Boehringer Ingelheim Investigational Site 17
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site 18
city: Dortmund
country: Germany
facility: Boehringer Ingelheim Investigational Site 19
city: Duisburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 20
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 21
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 22
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 23
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 24
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 25
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 26
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 27
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 28
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 29
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 30
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 31
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 32
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 33
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 34
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 35
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 36
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 37
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 38
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 39
city: Heidelberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 40
city: Karlsruhe
country: Germany
facility: Boehringer Ingelheim Investigational Site 41
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site 42
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site 43
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 44
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 45
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 46
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 47
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 48
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 49
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 50
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 51
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 52
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 53
city: Oldenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 54
city: Osnabrück
country: Germany
facility: Boehringer Ingelheim Investigational Site 55
city: Saarbrücken
country: Germany
facility: Boehringer Ingelheim Investigational Site 56
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 57
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 58
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 59
city: Wuppertal
country: Germany
facility: Boehringer Ingelheim Investigational Site 60
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: