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

This study is ongoing, but not recruiting participants.

First Received: February 6, 2007 Last Updated: November 4, 2009 History of Changes

Sponsor:	Montefiore Medical Center
Collaborator:	Abbott
Information provided by:	Montefiore Medical Center
ClinicalTrials.gov Identifier:	NCT00432783

Purpose

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.

Condition
HIV Infections

Study Type:	Observational
Study Design:	Cohort, 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:

MedlinePlus related topics: AIDS

Drug Information available for: Ritonavir

U.S. FDA Resources

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.

Eligibility

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.

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 inhibitor

Contacts and Locations

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

Locations

United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467

Sponsors and Collaborators

Montefiore Medical Center

Abbott

Investigators

Principal Investigator:

Jonathan Shuter, MD

Montefiore Medical Center

More Information

No publications provided by Montefiore Medical Center

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Shuter J, Sarlo JA, Rode RA, Zingman BS. Occurrence of selective ritonavir nonadherence and dose-staggering in recipients of boosted HIV-1 protease inhibitor therapy. HIV Clin Trials. 2009 May-Jun;10(3):135-42.

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

Keywords provided by Montefiore Medical Center:

HIV, antiretroviral therapy, adherence, ritonavir

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents

Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Ritonavir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010