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
|
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Condition or disease |
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HIV |
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 |

Group/Cohort |
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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
|
- 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 ]
- 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 ]

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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 |
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

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
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
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 |