Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00876733
First received: March 20, 2009
Last updated: January 14, 2015
Last verified: January 2015
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Purpose
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim:
Primary Outcome Measures:
- Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs [ Time Frame: 36 months ] [ Designated as safety issue: No ]Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
Secondary Outcome Measures:
- Changes in the Viral Load After 12 Months From Baseline. [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.
- Changes in the Viral Load After 36 Months From Baseline. [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.
- Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline. [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.
- Changes in the CD4+ Cell Count After 36 Months From Baseline. [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.
- Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (ALT) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (AST) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (ALT) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (AST) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
- Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
| Enrollment: | 605 |
| Study Start Date: | March 2009 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| HIV treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients
Criteria
Inclusion criteria:
- male and female
- 18 years or older
- written informed consent
- The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC
Exclusion criteria:
- Pregnant patients
- The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC
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: NCT00876733
Show 66 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876733
Show 66 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
More Information
Additional Information:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00876733 History of Changes |
| Other Study ID Numbers: | 1100.1524 |
| Study First Received: | March 20, 2009 |
| Results First Received: | December 27, 2014 |
| Last Updated: | January 14, 2015 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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 |
ClinicalTrials.gov processed this record on September 30, 2016