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

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ClinicalTrials.gov Identifier: NCT00432783
Recruitment Status : Completed
First Posted : February 8, 2007
Last Update Posted : April 27, 2018
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Jonathan Shuter, Montefiore Medical Center

February 6, 2007
February 8, 2007
April 27, 2018
June 2006
August 2007   (Final data collection date for primary outcome measure)
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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. doi: 10.1310/hct1003-135.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
Same as current
August 2007
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00432783
06-01-023E
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Jonathan Shuter, Montefiore Medical Center
Montefiore Medical Center
Abbott
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
Montefiore Medical Center
April 2018