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Comparative Tolerability of Protease Inhibitors

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ClinicalTrials.gov Identifier: NCT01450618
Recruitment Status : Completed
First Posted : October 12, 2011
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
HIV

Study Design
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Study Type : Observational
Actual Enrollment : 26000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs
Study Start Date : March 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Healthcare utilization [ Time Frame: 6 months ]
  3. Healthcare costs [ Time Frame: 6 months ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450618


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

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