Status:
COMPLETED
Evaluation of Atazanavir Substitution Intervention (EASI) Study
Lead Sponsor:
University of British Columbia
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
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 \[Perelson, 1997\]. Subs...
Detailed Description
This will be a single arm observational study to include 100 subjects. After a clinical decision is made to implement a single drug substitution to ATV +/- RTV, there will be an initial screening visi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00247845
Start Date
July 1 2004
End Date
September 1 2007
Last Update
August 22 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Downtown Infectious Diseases Clinic,
Vancouver, British Columbia, Canada
2
Oak Tree Clinic
Vancouver, British Columbia, Canada
3
Pender Community Health Center
Vancouver, British Columbia, Canada
4
Vancouver General Hospital Clinic
Vancouver, British Columbia, Canada