Comparative Tolerability of Protease Inhibitors

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01450618

First Posted: October 12, 2011

Last Update Posted: December 5, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Bristol-Myers Squibb

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 ]

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 ]
Healthcare utilization [ Time Frame: 6 months ]
Healthcare costs [ Time Frame: 6 months ]


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

Information from the National Library of Medicine

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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

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

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 Submitted:	September 21, 2011
First Posted:	October 12, 2011
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

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