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Comparative Tolerability of Protease Inhibitors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01450618
First received: September 21, 2011
Last updated: December 4, 2012
Last verified: December 2012
History of Changes

September 21, 2011
December 4, 2012
March 2011
November 2011   (final data collection date for primary outcome measure)
Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01450618 on ClinicalTrials.gov Archive Site
  • Percent of patients with new onset lipid abnormalities or new onset jaundice (separately) after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Healthcare utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Healthcare costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparative Tolerability of Protease Inhibitors
Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs

This study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV) patients treated with cART regimens including one of four different protease inhibitors [Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)] and the impact of these identifiable tolerability problems on PI persistence, healthcare utilization, and healthcare costs.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Employees and dependents with employer-based health insurance coverage
HIV
Not Provided
  • Atazanavir
    HIV patients on antiretroviral therapy using Atazanavir
  • Darunavir
    HIV patients on antiretroviral therapy using Darunavir
  • Fosamprenavir
    HIV patients on antiretroviral therapy using Fosamprenavir
  • Lopinavir
    HIV patients on antiretroviral therapy using Lopinavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26000
October 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Initiated treatment with a Protease inhibitor (PI)-based Combination antiretroviral therapy (cART) regimen
  • Between 18-64 years of age on the index date
  • At least 6 months of continuous enrollment and pharmacy benefits prior to the index date
  • At least 6 months of continuous enrollment and pharmacy benefits following the index date
  • At least 1 medical claim during the 6-month follow-up period
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01450618
AI424-435
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2012

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