Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247845
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2005-10-31
Brief Title:
Evaluation of Atazanavir Substitution Intervention EASI Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 cellsmm³ may safely delay initiation of HAART Yeni 2002However 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
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
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 visit at which time the study will be presented to the patient and informed consent for participation will be obtained A number of evaluations including blood tests will be completed to definitively assess a subjects eligibility to participate in this protocol The patients will continue on their current therapy and will return within the next 14 days for an enrollment visit to review the blood test results and definitively confirm study eligibility In particular we will ascertain the continued presence of the side effecttoxicity motivating consideration of a change in therapy This being down the quality of life questionnaires MOS-HIV and ASDM will be administered for the first time Once again the patient will continue on their current HAART and return within the next 14 days for a baseline visit at which time the quality of life questionnaires MOS-HIV and ASDM will be administered once again the results being averaged with those obtained at the time of the enrollment visit this serving as a more rigorous evaluation of the patients current status The patient could be withdrawn from the study if the side effecttoxicity motivating consideration of a change in therapy is no longer present At this baseline visit all patients will switch the PI or NNRTI component of their regimen to ATV - RTV The decision to use boosted or unboosted ATV in this protocol will be left to the discretion of the treating physician All patients will be receiving ATV - RTV with food The dose of the unboosted ATV will be 300 mg 2 capsules 150mg each plus RTV 1 capsule 100 mg The patients will then be seen in follow up at weeks 4 12 24 32 and 48 after the baseline visit They will continue on their new therapy including ATV - RTV for this entire period of observation Changes in the NRTI backbone will be permitted without constituting a study endpoint while changes in the ATV - RTV that may be required for reasons of efficacy or toxicity will constitute such an endpoint leading to a patients withdrawal from the study At each study visit the quality of life questionnaires MOS-HIV and ASDM will be administered The results will be compared to the mean results obtained at the enrollment and baseline visits with each individual participant serving as hisher own control Measures of adherence to HAART CD4 cell counts and HIV plasma viral load will also be obtained at each study visit and will constitute secondary study endpoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None