Comparative Tolerability of Protease Inhibitors

HIV Clinical Trial

Official title:

Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450618
• Other study ID #: AI424-435
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: December 4, 2012
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26000
• Est. completion date: October 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen		6 months	No
Secondary	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	No
Secondary	Healthcare utilization		6 months	No
Secondary	Healthcare costs		6 months	No

External Links

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