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
ClinicalTrials.gov Identifier:
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.

HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Montefiore Medical Center:

Estimated Enrollment: 45
Study Start Date: June 2006
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Principal Investigator: Jonathan Shuter, MD Montefiore Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roxann Stubbs/Clinical Science Manager, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT00432783     History of Changes
Other Study ID Numbers: 06-01-023E 
Study First Received: February 6, 2007
Last Updated: November 4, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
HIV, antiretroviral therapy, adherence, ritonavir

Additional relevant MeSH terms:
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2016