Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients

This study has been completed.
Sponsor:
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

March 20, 2009
January 14, 2015
March 2009
December 2013   (final data collection date for primary outcome measure)
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
The frequency of treatment emergent Adverse Events (AE) and all Serious AEs. [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00876733 on ClinicalTrials.gov Archive Site
  • 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.
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Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

patients

HIV Infections
Not Provided
HIV treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
605
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00876733
1100.1524
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP