Comparative Tolerability of Protease Inhibitors
Completed
- Conditions
- HIV
- Registration Number
- NCT01450618
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26000
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
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen 6 months
- Secondary Outcome Measures
Name Time Method 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 6 months Healthcare utilization 6 months Healthcare costs 6 months