- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00432783
A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor
April 25, 2018 updated by: Jonathan Shuter, Montefiore Medical Center
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Anticipated)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Shuter, MD, Montefiore Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2006
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
February 6, 2007
First Submitted That Met QC Criteria
February 7, 2007
First Posted (Estimate)
February 8, 2007
Study Record Updates
Last Update Posted (Actual)
April 27, 2018
Last Update Submitted That Met QC Criteria
April 25, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-01-023E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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