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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

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ClinicalTrials.gov Identifier: NCT00979420
Recruitment Status : Completed
First Posted : September 18, 2009
Results First Posted : August 16, 2012
Last Update Posted : June 30, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Description
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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.

Condition or disease
HIV Infections

Detailed Description:

Study Design:

observational


Study Design
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Study Type : Observational
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
Study Start Date : August 2009
Actual Primary Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine

Groups and Cohorts
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Group/Cohort
HIV treatment


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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.

  2. 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. ]
  3. 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. ]
    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.

  4. 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. ]
    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 :
  1. Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade [ Time Frame: 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.

  2. 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 ]
    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.

  3. Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade [ Time Frame: 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.

  4. Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade [ Time Frame: 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.

  5. Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade [ Time Frame: 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.

  6. Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade [ Time Frame: 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.

  7. Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade [ Time Frame: 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.

  8. Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade [ Time Frame: 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.

  9. Duration of Intake of Viramune [ Time Frame: End of treatment, up to 185 months ]
    Duration of intake of Viramune

  10. History of Therapy With Antiretroviral Medication [ Time Frame: Baseline ]
    Participants with a history of therapy with antiretroviral medication.

  11. Course of Absolute CD4+ Cell Count [ Time Frame: 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.

  12. Number of Participants With Drug Related Adverse Events [ Time Frame: Up to 185 months ]
    Number of participants with drug related Adverse Events (AEs)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979420


  Show 60 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00979420     History of Changes
Other Study ID Numbers: 1100.1535
First Posted: September 18, 2009    Key Record Dates
Results First Posted: August 16, 2012
Last Update Posted: June 30, 2014
Last Verified: June 2014

Keywords provided by Boehringer Ingelheim:
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nevirapine
 Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers