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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

Tracking Information
First Submitted Date February 6, 2007
First Posted Date February 8, 2007
Last Update Posted Date April 27, 2018
Actual Study Start Date June 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00432783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor
Official Title A Comparison of Adherence Rates to Ritonavir (Soft-gel Capsules) and Its Accompanying Protease Inhibitor (PI) in Patients Receiving Ritonavir Boosted PI Regimens
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic who meet eligibility criteria described below.
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: February¬†7,¬†2007)
45
Original Enrollment Same as current
Actual Study Completion Date August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00432783
Other Study ID Numbers 06-01-023E
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jonathan Shuter, Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Abbott
Investigators
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date April 2018