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
Information provided by:
Montefiore Medical Center
First received: February 6, 2007
Last updated: November 4, 2009
Last verified: November 2009
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Comparison of Adherence Rates to Ritonavir (Soft-gel Capsules) and Its Accompanying Protease Inhibitor (PI) in Patients Receiving Ritonavir Boosted PI Regimens
| Estimated Enrollment:
| Study Start Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Subjects will be recruited from the Montefiore Medical Center Infectious Diseases Clinic who meet eligibility criteria described below.
- HIV infection, age>18 years, receiving therapy with ritonavir-boosted atazanavir or fosamprenavir, willingness to use MEMS caps, willingness to provide informed consent
- Treatment with any medication that is contraindicated in combination with ritonavir or its accompanying protease inhibitor
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432783
|Montefiore Medical Center
|Bronx, New York, United States, 10467 |
Montefiore Medical Center
||Jonathan Shuter, MD
||Montefiore Medical Center
No publications provided by Montefiore Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
||Roxann Stubbs/Clinical Science Manager, Abbott Laboratories
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 6, 2007
||November 4, 2009
||United States: Institutional Review Board
Keywords provided by Montefiore Medical Center:
HIV, antiretroviral therapy, adherence, ritonavir
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 20, 2014
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action