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Clinical Trials/NCT00876733
NCT00876733
Completed
Not Applicable

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

Boehringer Ingelheim66 sites in 1 country605 target enrollmentMarch 2009
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ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
Boehringer Ingelheim
Enrollment
605
Locations
66
Primary Endpoint
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
December 2013
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Viral Load After 36 Months From Baseline.(Baseline and 36 months)
  • Changes in the Laboratory Data (AST) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Viral Load After 12 Months From Baseline.(Baseline and 12 months)
  • Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.(Baseline and 12 months)
  • Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the CD4+ Cell Count After 36 Months From Baseline.(Baseline and 36 months)
  • Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (ALT) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline(Baseline and 12 months)
  • Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (AST) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (ALT) After 36 Months From Baseline(Baseline and 36 months)
  • Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline(Baseline and 36 months)

Study Sites (66)

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