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
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Study Start Date: August 2009
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV treatment

Detailed Description:

Study Design:

observational

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979420

  Show 60 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00979420     History of Changes
Other Study ID Numbers: 1100.1535
Study First Received: September 16, 2009
Results First Received: May 30, 2012
Last Updated: June 27, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Boehringer Ingelheim:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014