- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247845
Evaluation of Atazanavir Substitution Intervention (EASI) Study
Evaluation of Atazanavir Substitution Intervention (EASI) Study: An Observational Phase IV Study to Evaluate the Impact of Atazanavir Substitution on the Quality of Life and Maintenance of Virologic Suppression in HIV-Infected Patients Intolerant to Current Successful HAART
With the advent of highly active antiretroviral therapy (HAART), it was hypothesized that its consistent use could lead to a cure for HIV infection in as little as three years [Perelson, 1997]. Subsequent research has shown this model to be incorrect [Finzi, 1999]. In addition, long term use of HAART has now been associated with significant metabolic abnormalities, which could lead to unintended morbidity, possibly worse than what one could expect from the progression of untreated HIV-associated immune disease over the same period of time [Carr, 2000]. Accordingly, current recommendations for antiretroviral therapy have become more conservative. It is now suggested that a person with a CD4 count > 350 cells/mm³ may safely delay initiation of HAART [Yeni, 2002].However, for those who still require HAART, the risks of short-term and long-term toxicities remain, even if full virologic suppression is achieved. In this setting, a number of switching strategies have been evaluated (Negredo et al, 2002 & Martinez et al, 2003), mostly involving single drug substitutions of a protease inhibitor (PI) for a non-nucleoside agent (NNRTI) or abacavir (ABC). In general terms, these hae shown that virologic suppression is usually maintained, with improvement in drug-related side effects, including metabolic toxicities. A number of patients who are currently taking effective HAART are experiencing side effects to one or more of the agents in their regimen that is not severe enough to mandate an immediate change in their regimen, but that is having a measurable effect on their qualify of life. Over time, these effects may have an impact on adherence to therapy and its long-term efficacy. Given the recent availability of ATV (+/-RTV), its once daily administration, low pill count and favourable side effect profile, it is being used in clinical practice as part of single drug substitution strategies in patients exhibiting a maximal response to HAART. There is a clear need to examine this practice in a systematic manner to document its occurrence, efficacy and safety.
We hypothesize that, in patients with maximal virologic suppression on a double class regimen (including two NRTIs and an NNRTI or a PI, boosted with RTV or not), and in whom a decision has been made to implement a single drug substitution of the NNRTI or PI for ATV (+/-), this will lead to an improvement in objectively measured quality of life without any negative impact on the virologic efficacy of the regimen.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada
- Downtown Infectious Diseases Clinic,
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Vancouver, British Columbia, Canada
- Oak Tree Clinic
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Vancouver, British Columbia, Canada
- Pender Community Health Center
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Vancouver, British Columbia, Canada
- Vancouver General Hospital Clinic
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Victoria, British Columbia, Canada
- Cool-Aid Society in Victoria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
18 years of age or older; a confirmed diagnosis of HIV infection; 2 consecutive HIV RNA levels <50 copies/mL with the most recent being within the past 3 months; have been on the same HAART regimen for the past 3 months; have side effects to their current antiretroviral medications that warrant a consideration of a change in therapy. There must be a clinical suspicion by the investigator that these side effects are attributable to either the PI or the NNRTI component of the regimen; Have agreement between the treating physician and the patient that a single drug substitution to ATV +/- RTV will be proposed, independent of participation in the study; be able to provide written informed consent and complete the quality of life instruments and, in the opinion of the investigator, comply in every other way with the requirements of the study protocol.
Exclusion Criteria:
Exclusion criteria: Have received investigational drug within 30 days prior to the baseline visit of the study; if female, be pregnant or breast-feeding; have an acute illness, including an acute opportunistic infection; have grade 3-4 laboratory abnormalities on any of the following parameters: CBC, ALT, AST, GGT, LDH, bilirubin, amylase, and alkaline phosphatase.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian Conway, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P04-0098
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