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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00979420
First received: September 16, 2009
Last updated: June 27, 2014
Last verified: June 2014

September 16, 2009
June 27, 2014
August 2009
November 2010   (final data collection date for primary outcome measure)
  • Change in log10 Viral Load From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit [ Time Frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]
  • Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]
    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.
  • Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months. ] [ Designated as safety issue: No ]
    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.
Lessening (or maintenance) of the virus load to a value that is below the detection limit for change in the CD4 cell count from baseline [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00979420 on ClinicalTrials.gov Archive Site
  • Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]
    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.
  • Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]
    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.
  • Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]
    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.
  • Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]
    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.
  • Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: Yes ]
    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.
  • Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: Yes ]
    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.
  • Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]
    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.
  • Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]
    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.
  • Duration of Intake of Viramune [ Time Frame: End of treatment, up to 185 months ] [ Designated as safety issue: No ]
    Duration of intake of Viramune
  • History of Therapy With Antiretroviral Medication [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Participants with a history of therapy with antiretroviral medication.
  • Course of Absolute CD4+ Cell Count [ Time Frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months ] [ Designated as safety issue: No ]
    The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.
  • Number of Participants With Drug Related Adverse Events [ Time Frame: Up to 185 months ] [ Designated as safety issue: No ]
    Number of participants with drug related Adverse Events (AEs)
Collection of AEs and SAEs Variations in laboratory values from normal levels as well as changes in comparison to baseline values [ Time Frame: 12 months ]
Not Provided
Not Provided
 
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
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

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.

Study Design:

observational

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

patients

HIV Infections
Not Provided
HIV treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
November 2010   (final data collection date for primary outcome measure)

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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00979420
1100.1535
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP