A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor

This study is currently recruiting participants.

Verified by Montefiore Medical Center, February 2007

Sponsors and Collaborators:	Montefiore Medical Center Abbott
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00432783

Purpose

Pharmacologic boosting of protease inhbitors 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.

Condition
HIV Infections

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
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

Further study details as provided by Montefiore Medical Center:

Estimated Enrollment:

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.

Eligibility

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

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 inhibitore

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432783

Contacts

Contact: Jonathan Shuter, MD	718-920-7845	jshuter@montefiore.org
Contact: Julie Sarlo, PA	718-920-7926	jsarlo@montefiore.org

Locations

United States, New York
Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10467
Contact: Jonathan Shuter, MD 718-920-7845 jshuter@montefiore.org
Contact: Julie Sarlo, PA 718-920-7926 jsarlo@montefiore.org
Principal Investigator: Jonathan Shuter, MD

Sponsors and Collaborators

Montefiore Medical Center

Abbott

Investigators

Principal Investigator:

Jonathan Shuter, MD

Montefiore Medical Center

More Information

Study ID Numbers:	06-01-023E
Study First Received:	February 6, 2007
Last Updated:	February 7, 2007
ClinicalTrials.gov Identifier:	NCT00432783
Health Authority:	United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:

HIV, antiretroviral therapy, adherence, ritonavir

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 16, 2009