Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
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ClinicalTrials.gov Identifier: NCT00876733 |
Recruitment Status
:
Completed
First Posted
: April 7, 2009
Results First Posted
: January 16, 2015
Last Update Posted
: January 16, 2015
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Condition or disease |
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HIV Infections |
Study Type : | Observational |
Actual Enrollment : | 605 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Group/Cohort |
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HIV treatment |
- Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs [ Time Frame: 36 months ]Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
- Changes in the Viral Load After 12 Months From Baseline. [ Time Frame: Baseline and 12 months ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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): NCT00876733

Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT00876733 History of Changes |
Other Study ID Numbers: |
1100.1524 |
First Posted: | April 7, 2009 Key Record Dates |
Results First Posted: | January 16, 2015 |
Last Update Posted: | January 16, 2015 |
Last Verified: | January 2015 |
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 |