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.

Study Overview

• Status: Completed
• Conditions: HIV

• Study Type: Observational
• Enrollment (Actual): 26000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Employees and dependents with employer-based health insurance coverage

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trials Disclosure
• For FDA Safety Alerts and Recalls refer to the following link:

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: October 11, 2011
• First Posted (Estimate): October 12, 2011

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: AI424-435