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Comparative Tolerability of Protease Inhibitors

NCT ID: NCT01450618

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Atazanavir

HIV patients on antiretroviral therapy using Atazanavir

No interventions assigned to this group

Darunavir

HIV patients on antiretroviral therapy using Darunavir

No interventions assigned to this group

Fosamprenavir

HIV patients on antiretroviral therapy using Fosamprenavir

No interventions assigned to this group

Lopinavir

HIV patients on antiretroviral therapy using Lopinavir

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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http://www.bms.com/clinical_trials/Pages/home.aspx

BMS Clinical Trials Disclosure

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

For FDA Safety Alerts and Recalls refer to the following link:

Other Identifiers

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AI424-435

Identifier Type: -

Identifier Source: org_study_id