Comparative Tolerability of Protease Inhibitors
This study has been completed.
Sponsor:
Bristol-Myers Squibb
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
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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:
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 |
| 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 More Information
Additional Information:
No publications provided
| 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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents |
Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses HIV Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013