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

NCT00979420 | Completed Results

• 1 other identifier: 1100.1535
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 60

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.

Conditions

HIV Infections

Keywords

treatment experienced

Outcome Measures

Primary Outcomes (4)

• Change in log10 Viral Load From Baseline to Last Visit

  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

  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

  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

  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.

Secondary Outcomes (12)

• Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade

  Up to 185 months

• Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade

  Up to 185 months

• Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade

  Up to 185 months

• Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade

  Up to 185 months

• Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade

  Up to 185 months

Study Arms (1)

HIV treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (60)

Boehringer Ingelheim Investigational Site 1

Aachen, Germany

Location

Boehringer Ingelheim Investigational Site 10

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 11

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 12

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 13

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 14

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 15

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 2

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 3

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 4

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 5

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 6

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 7

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 8

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 9

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site 16

Bochum, Germany

Location

Boehringer Ingelheim Investigational Site 17

Bonn, Germany

Location

Boehringer Ingelheim Investigational Site 18

Bremen, Germany

Location

Boehringer Ingelheim Investigational Site 19

Dortmund, Germany

Location

Boehringer Ingelheim Investigational Site 20

Duisburg, Germany

Location

Boehringer Ingelheim Investigational Site 21

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 22

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 23

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 24

Düsseldorf, Germany

Location

Boehringer Ingelheim Investigational Site 25

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 26

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 27

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site 28

Freiburg im Breisgau, Germany

Location

Boehringer Ingelheim Investigational Site 29

Freiburg im Breisgau, Germany

Location

Boehringer Ingelheim Investigational Site 30

Freiburg im Breisgau, Germany

Location

Boehringer Ingelheim Investigational Site 31

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 32

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 33

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 34

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 35

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 36

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site 37

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 38

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 39

Hanover, Germany

Location

Boehringer Ingelheim Investigational Site 40

Heidelberg, Germany

Location

Boehringer Ingelheim Investigational Site 41

Karlsruhe, Germany

Location

Boehringer Ingelheim Investigational Site 42

Koblenz, Germany

Location

Boehringer Ingelheim Investigational Site 43

Leipzig, Germany

Location

Boehringer Ingelheim Investigational Site 44

Mannheim, Germany

Location

Boehringer Ingelheim Investigational Site 45

Mannheim, Germany

Location

Boehringer Ingelheim Investigational Site 46

München, Germany

Location

Boehringer Ingelheim Investigational Site 47

München, Germany

Location

Boehringer Ingelheim Investigational Site 48

München, Germany

Location

Boehringer Ingelheim Investigational Site 49

München, Germany

Location

Boehringer Ingelheim Investigational Site 50

München, Germany

Location

Boehringer Ingelheim Investigational Site 51

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 52

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 53

Münster, Germany

Location

Boehringer Ingelheim Investigational Site 54

Oldenburg, Germany

Location

Boehringer Ingelheim Investigational Site 55

Osnabrück, Germany

Location

Boehringer Ingelheim Investigational Site 56

Saarbrücken, Germany

Location

Boehringer Ingelheim Investigational Site 57

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 58

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 59

Stuttgart, Germany

Location

Boehringer Ingelheim Investigational Site 60

Wuppertal, Germany

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 18, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2010
• Last Updated: June 30, 2014
• Results First Posted: August 16, 2012

Record last verified: 2014-06

Locations

DE (60)