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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
  Purpose
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.

Condition
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 26000
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Employees and dependents with employer-based health insurance coverage
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450618

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link:  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01450618     History of Changes
Other Study ID Numbers: AI424-435 
Study First Received: September 21, 2011
Last Updated: December 4, 2012
Health Authority: United States: No Health Authority

Additional relevant MeSH terms:
Protease Inhibitors
Fosamprenavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 30, 2016