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

Boehringer Ingelheim

Overview

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

Study Type

OBSERVATIONAL

Conditions

HIV Infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (60)

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Secondary Outcomes

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

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.

Time frame: Up to 185 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Boehringer Ingelheim Investigational Site 1

Aachen, Germany

Boehringer Ingelheim Investigational Site 10

Berlin, Germany

Boehringer Ingelheim Investigational Site 11

Berlin, Germany

Boehringer Ingelheim Investigational Site 12

Berlin, Germany

Boehringer Ingelheim Investigational Site 13

Berlin, Germany

Boehringer Ingelheim Investigational Site 14

Berlin, Germany

Boehringer Ingelheim Investigational Site 15

Berlin, Germany

Boehringer Ingelheim Investigational Site 2

Berlin, Germany

Boehringer Ingelheim Investigational Site 3

Berlin, Germany

Boehringer Ingelheim Investigational Site 4

Berlin, Germany

...and 50 more locations

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

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.

Time frame: Up to 185 months

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

Time frame: Up to 185 months

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

Time frame: Up to 185 months

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

Time frame: Up to 185 months

Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade

Time frame: Up to 185 months

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

Time frame: Up to 185 months

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

Duration of intake of Viramune

Time frame: End of treatment, up to 185 months

History of Therapy With Antiretroviral Medication

Participants with a history of therapy with antiretroviral medication.

Time frame: Baseline

Course of Absolute CD4+ Cell Count

The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.

Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months

Number of Participants With Drug Related Adverse Events

Number of participants with drug related Adverse Events (AEs)

Time frame: Up to 185 months