A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor
This trial is active, not recruiting.
|Sponsor||Montefiore Medical Center|
|Start date||June 2006|
|Trial size||45 participants|
|Trial identifier||NCT00432783, 06-01-023E|
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.
Male or female participants at least 18 years old.
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
|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|
|Principal investigator||Jonathan Shuter, MD|
|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.|
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