Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT00979420
  4. Details
NCT00979420 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00979420
Other study ID # 1100.1535
Secondary ID
Status Completed
Phase N/A
First received September 16, 2009
Last updated June 27, 2014
Start date August 2009

Study information
Verified date June 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Description:

Study Design:

observational

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany 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 Boehringer Ingelheim Investigational Site 5 Berlin
Germany Boehringer Ingelheim Investigational Site 6 Berlin
Germany Boehringer Ingelheim Investigational Site 7 Berlin
Germany Boehringer Ingelheim Investigational Site 8 Berlin
Germany Boehringer Ingelheim Investigational Site 9 Berlin
Germany Boehringer Ingelheim Investigational Site 16 Bochum
Germany Boehringer Ingelheim Investigational Site 17 Bonn
Germany Boehringer Ingelheim Investigational Site 18 Bremen
Germany Boehringer Ingelheim Investigational Site 19 Dortmund
Germany Boehringer Ingelheim Investigational Site 20 Duisburg
Germany Boehringer Ingelheim Investigational Site 21 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 22 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 23 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 24 Düsseldorf
Germany Boehringer Ingelheim Investigational Site 25 Frankfurt
Germany Boehringer Ingelheim Investigational Site 26 Frankfurt
Germany Boehringer Ingelheim Investigational Site 27 Frankfurt
Germany Boehringer Ingelheim Investigational Site 28 Freiburg
Germany Boehringer Ingelheim Investigational Site 29 Freiburg
Germany Boehringer Ingelheim Investigational Site 30 Freiburg
Germany Boehringer Ingelheim Investigational Site 31 Hamburg
Germany Boehringer Ingelheim Investigational Site 32 Hamburg
Germany Boehringer Ingelheim Investigational Site 33 Hamburg
Germany Boehringer Ingelheim Investigational Site 34 Hamburg
Germany Boehringer Ingelheim Investigational Site 35 Hamburg
Germany Boehringer Ingelheim Investigational Site 36 Hamburg
Germany Boehringer Ingelheim Investigational Site 37 Hannover
Germany Boehringer Ingelheim Investigational Site 38 Hannover
Germany Boehringer Ingelheim Investigational Site 39 Hannover
Germany Boehringer Ingelheim Investigational Site 40 Heidelberg
Germany Boehringer Ingelheim Investigational Site 41 Karlsruhe
Germany Boehringer Ingelheim Investigational Site 42 Koblenz
Germany Boehringer Ingelheim Investigational Site 43 Leipzig
Germany Boehringer Ingelheim Investigational Site 44 Mannheim
Germany Boehringer Ingelheim Investigational Site 45 Mannheim
Germany Boehringer Ingelheim Investigational Site 46 München
Germany Boehringer Ingelheim Investigational Site 47 München
Germany Boehringer Ingelheim Investigational Site 48 München
Germany Boehringer Ingelheim Investigational Site 49 München
Germany Boehringer Ingelheim Investigational Site 50 München
Germany Boehringer Ingelheim Investigational Site 51 Münster
Germany Boehringer Ingelheim Investigational Site 52 Münster
Germany Boehringer Ingelheim Investigational Site 53 Münster
Germany Boehringer Ingelheim Investigational Site 54 Oldenburg
Germany Boehringer Ingelheim Investigational Site 55 Osnabrück
Germany Boehringer Ingelheim Investigational Site 56 Saarbrücken
Germany Boehringer Ingelheim Investigational Site 57 Stuttgart
Germany Boehringer Ingelheim Investigational Site 58 Stuttgart
Germany Boehringer Ingelheim Investigational Site 59 Stuttgart
Germany Boehringer Ingelheim Investigational Site 60 Wuppertal

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. No
Primary 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. No
Primary 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. No
Primary 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. No
Secondary 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. Up to 185 months No
Secondary 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. Up to 185 months No
Secondary Number of Patients With Laboratory Abnormalities for Triglycerides 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. Up to 185 months No
Secondary Number of Patients With Laboratory Abnormalities for Blood Glucose 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. Up to 185 months No
Secondary Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) 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. Up to 185 months Yes
Secondary Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) 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. Up to 185 months Yes
Secondary Number of Patients With Laboratory Abnormalities for Creatinine 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. Up to 185 months No
Secondary Number of Patients With Laboratory Abnormalities for Hemoglobin 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. Up to 185 months No
Secondary Duration of Intake of Viramune Duration of intake of Viramune End of treatment, up to 185 months No
Secondary History of Therapy With Antiretroviral Medication Participants with a history of therapy with antiretroviral medication. Baseline No
Secondary Course of Absolute CD4+ Cell Count The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit. Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months No
Secondary Number of Participants With Drug Related Adverse Events Number of participants with drug related Adverse Events (AEs) Up to 185 months No
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2

External Links