Comparative Tolerability of Protease Inhibitors

NCT01450618 | Completed

• 1 other identifier: AI424-435
• Study Type: observational
• Target: 26,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Employees and dependents with employer-based health insurance coverage

You may qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 12, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: October 1, 2012
• Last Updated: December 5, 2012

Record last verified: 2012-12