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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876733
• Other study ID #: 1100.1524
• Status: Completed
• Phase: N/A
• First received: March 20, 2009
• Last updated: January 14, 2015
• Start date: March 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Germany	Boehringer Ingelheim Investigational Site 14	Aachen
Germany	Boehringer Ingelheim Investigational Site 12	Berlin
Germany	Boehringer Ingelheim Investigational Site 13	Berlin
Germany	Boehringer Ingelheim Investigational Site 15	Berlin
Germany	Boehringer Ingelheim Investigational Site 19	Berlin
Germany	Boehringer Ingelheim Investigational Site 21	Berlin
Germany	Boehringer Ingelheim Investigational Site 23	Berlin
Germany	Boehringer Ingelheim Investigational Site 24	Berlin
Germany	Boehringer Ingelheim Investigational Site 28	Berlin
Germany	Boehringer Ingelheim Investigational Site 30	Berlin
Germany	Boehringer Ingelheim Investigational Site 31	Berlin
Germany	Boehringer Ingelheim Investigational Site 34	Berlin
Germany	Boehringer Ingelheim Investigational Site 38	Berlin
Germany	Boehringer Ingelheim Investigational Site 41	Berlin
Germany	Boehringer Ingelheim Investigational Site 54	Berlin
Germany	Boehringer Ingelheim Investigational Site 60	Berlin
Germany	Boehringer Ingelheim Investigational Site 63	Berlin
Germany	Boehringer Ingelheim Investigational Site 8	Berlin
Germany	Boehringer Ingelheim Investigational Site 58	Bochum
Germany	Boehringer Ingelheim Investigational Site 50	Chemnitz
Germany	Boehringer Ingelheim Investigational Site 48	Dortmund
Germany	Boehringer Ingelheim Investigational Site 27	Duisburg
Germany	Boehringer Ingelheim Investigational Site 49	Düsseldorf
Germany	Boehringer Ingelheim Investigational Site 62	Düsseldorf
Germany	Boehringer Ingelheim Investigational Site 9	Düsseldorf
Germany	Boehringer Ingelheim Investigational Site 32	Frankfurt
Germany	Boehringer Ingelheim Investigational Site 59	Frankfurt
Germany	Boehringer Ingelheim Investigational Site 65	Frankfurt
Germany	Boehringer Ingelheim Investigational Site 57	Freiburg
Germany	Boehringer Ingelheim Investigational Site 56	Fürth
Germany	Boehringer Ingelheim Investigational Site 29	Gießen
Germany	Boehringer Ingelheim Investigational Site 33	Hamburg
Germany	Boehringer Ingelheim Investigational Site 42	Hamburg
Germany	Boehringer Ingelheim Investigational Site 47	Hamburg
Germany	Boehringer Ingelheim Investigational Site 51	Hamburg
Germany	Boehringer Ingelheim Investigational Site 40	Hannover
Germany	Boehringer Ingelheim Investigational Site 43	Hannover
Germany	Boehringer Ingelheim Investigational Site 46	Hannover
Germany	Boehringer Ingelheim Investigational Site 6	Karlsruhe
Germany	Boehringer Ingelheim Investigational Site 25	Koblenz
Germany	Boehringer Ingelheim Investigational Site 53	Köln
Germany	Boehringer Ingelheim Investigational Site 61	Köln
Germany	Boehringer Ingelheim Investigational Site 37	Krefeld
Germany	Boehringer Ingelheim Investigational Site 11	Leipzig
Germany	Boehringer Ingelheim Investigational Site 52	Mainz
Germany	Boehringer Ingelheim Investigational Site 18	München
Germany	Boehringer Ingelheim Investigational Site 20	München
Germany	Boehringer Ingelheim Investigational Site 22	München
Germany	Boehringer Ingelheim Investigational Site 26	München
Germany	Boehringer Ingelheim Investigational Site 35	München
Germany	Boehringer Ingelheim Investigational Site 5	München
Germany	Boehringer Ingelheim Investigational Site 16	Münster
Germany	Boehringer Ingelheim Investigational Site 17	Münster
Germany	Boehringer Ingelheim Investigational Site 39	Münster
Germany	Boehringer Ingelheim Investigational Site 55	Münster
Germany	Boehringer Ingelheim Investigational Site 10	Neuss
Germany	Boehringer Ingelheim Investigational Site 36	Oldenburg
Germany	Boehringer Ingelheim Investigational Site 64	Osnabrück
Germany	Boehringer Ingelheim Investigational Site 7	Pforzheim
Germany	Boehringer Ingelheim Investigational Site 66	Potsdam
Germany	Boehringer Ingelheim Investigational Site 1	Stuttgart
Germany	Boehringer Ingelheim Investigational Site 3	Stuttgart
Germany	Boehringer Ingelheim Investigational Site 4	Stuttgart
Germany	Boehringer Ingelheim Investigational Site 45	Troisdorf
Germany	Boehringer Ingelheim Investigational Site 2	Wiesbaden
Germany	Boehringer Ingelheim Investigational Site 44	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs	Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs	36 months	No
Secondary	Changes in the Viral Load After 12 Months From Baseline.	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.	Baseline and 12 months	No
Secondary	Changes in the Viral Load After 36 Months From Baseline.	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.	Baseline and 36 months	No
Secondary	Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.	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.	Baseline and 12 months	No
Secondary	Changes in the CD4+ Cell Count After 36 Months From Baseline.	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (ALT) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (AST) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline	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.	Baseline and 12 months	No
Secondary	Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (ALT) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (AST) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline	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.	Baseline and 36 months	No
Secondary	Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline	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.	Baseline and 36 months	No

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