Clinical trial NCT00876733: Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
Official title: Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients

Brief 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).


Eligibility 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
timeFrame: 36 months
Secondary outcomes:
measure: Changes in the Viral Load After 12 Months From Baseline.
timeFrame: Baseline and 12 months
measure: Changes in the Viral Load After 36 Months From Baseline.
timeFrame: Baseline and 36 months
measure: Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.
timeFrame: Baseline and 12 months
measure: Changes in the CD4+ Cell Count After 36 Months From Baseline.
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (ALT) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (AST) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline
timeFrame: Baseline and 12 months
measure: Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (ALT) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (AST) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
timeFrame: Baseline and 36 months
measure: Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
timeFrame: Baseline and 36 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Boehringer Ingelheim Investigational Site 14
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 12
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 13
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 15
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 19
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 21
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 23
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 24
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 28
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 30
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 31
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 34
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 38
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 41
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 54
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 60
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 63
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 8
city: Bochum
country: Germany
facility: Boehringer Ingelheim Investigational Site 58
city: Chemnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site 50
city: Dortmund
country: Germany
facility: Boehringer Ingelheim Investigational Site 48
city: Duisburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 27
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 49
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 62
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 9
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 32
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 59
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 65
city: Freiburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 57
city: Fürth
country: Germany
facility: Boehringer Ingelheim Investigational Site 56
city: Gießen
country: Germany
facility: Boehringer Ingelheim Investigational Site 29
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 33
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 42
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 47
city: Hamburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 51
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 40
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 43
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 46
city: Karlsruhe
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Koblenz
country: Germany
facility: Boehringer Ingelheim Investigational Site 25
city: Krefeld
country: Germany
facility: Boehringer Ingelheim Investigational Site 37
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site 53
city: Köln
country: Germany
facility: Boehringer Ingelheim Investigational Site 61
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site 11
city: Mainz
country: Germany
facility: Boehringer Ingelheim Investigational Site 52
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 18
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 20
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 22
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 26
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 35
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 16
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 17
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 39
city: Münster
country: Germany
facility: Boehringer Ingelheim Investigational Site 55
city: Neuss
country: Germany
facility: Boehringer Ingelheim Investigational Site 10
city: Oldenburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 36
city: Osnabrück
country: Germany
facility: Boehringer Ingelheim Investigational Site 64
city: Pforzheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 7
city: Potsdam
country: Germany
facility: Boehringer Ingelheim Investigational Site 66
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Stuttgart
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Troisdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 45
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Wuppertal
country: Germany
facility: Boehringer Ingelheim Investigational Site 44
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: