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NCT00432783 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00432783
Other study ID # 06-01-023E
Secondary ID
Status Completed
Phase
First received February 6, 2007
Last updated April 25, 2018
Start date June 2006
Est. completion date August 2007

Study information
Verified date April 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (2)
Lead Sponsor Collaborator
Montefiore Medical Center Abbott

Country where clinical trial is conducted

United States, 

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