A Comparison of Adherence Rates to Ritonavir and Its Accompanying Protease Inhibitor
Recruitment status was Active, not recruiting
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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: | 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 |
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2006 |
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 |
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| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| 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 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 Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Protease Inhibitors Ritonavir Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013