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A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Montefiore Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00432783
First received: February 6, 2007
Last updated: November 4, 2009
Last verified: November 2009
History of Changes

February 6, 2007
November 4, 2009
June 2006
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Complete list of historical versions of study NCT00432783 on ClinicalTrials.gov Archive Site
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A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor
A Comparison of Adherence Rates to Ritonavir (Soft-gel Capsules) and Its Accompanying Protease Inhibitor (PI) in Patients Receiving Ritonavir Boosted PI Regimens

Pharmacologic boosting of protease inhibitors with ritonavir has become standard practice in antiretroviral therapy. Patients are instructed to take ritonavir at the same time as its accompanying protease inhibitor. However, ritonavir is unpopular with many patients because of its large size and because of the recommended need for refrigeration. This study will test the hypothesis that adherence to ritonavir is inferior to adherence to its accompanying protease inhibitor in patients receiving such therapy.

The study staff will employ MEMS caps to prospectively measure adherence to ritonavir and its accompanying protease inhibitor over 24 weeks of follow-up. Paired sample t-tests will be employed to compare adherence to the two agents, and secondary analyses will be conducted to evaluate the chronologic concordance of ritonavir and accompanying protease inhibitor dosing.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic who meet eligibility criteria described below.
HIV Infections
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Shuter J, Sarlo JA, Rode RA, Zingman BS. Occurrence of selective ritonavir nonadherence and dose-staggering in recipients of boosted HIV-1 protease inhibitor therapy. HIV Clin Trials. 2009 May-Jun;10(3):135-42.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
45
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Inclusion Criteria:

  • HIV infection, age>18 years, receiving therapy with ritonavir-boosted atazanavir or fosamprenavir, willingness to use MEMS caps, willingness to provide informed consent

Exclusion Criteria:

  • Treatment with any medication that is contraindicated in combination with ritonavir or its accompanying protease inhibitor
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00432783
06-01-023E
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Roxann Stubbs/Clinical Science Manager, Abbott Laboratories
Montefiore Medical Center
Abbott
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
Montefiore Medical Center
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP