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Sponsors and Collaborators: |
Montefiore Medical Center Abbott |
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Information provided by: | Montefiore Medical Center |
ClinicalTrials.gov Identifier: | NCT00432783 |
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 |
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HIV Infections |
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 |
Estimated Enrollment: | 45 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jonathan Shuter, MD | 718-920-7845 | jshuter@montefiore.org |
Contact: Julie Sarlo, PA | 718-920-7926 | jsarlo@montefiore.org |
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 |
Principal Investigator: | Jonathan Shuter, MD | Montefiore Medical Center |
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 |
HIV, antiretroviral therapy, adherence, ritonavir |
Virus Diseases Sexually Transmitted Diseases, Viral Ritonavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
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 |