Overview

CSP #512 - Options in Management With Anti-Retrovirals

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
US Department of Veterans Affairs
VA Office of Research and Development
Collaborators:
Canadian Institutes of Health Research (CIHR)
Medical Research Council
Treatments:
Anti-Retroviral Agents
Criteria
Inclusion Criteria:

- Ability to provide informed consent

- Age of 18 years or more

- Serologic or virologic diagnosis of HIV infection

- Failure of at least two different multi-drug regimens that include drugs of all 3
classes that the patient can tolerate or laboratory evidence of resistance to drugs in
each of the 3 classes

- Had at least 3 months of current ART and are still on treatment

- Two most recent results (which can include screening) on current ART of CD4 count less
than or equal to 300 cells/mm3 or less than or equal to 15%, and a plasma viral load
greater than or equal to 5,000 copies/ml (Roche Amplicor, v1.0), or greater than or
equal to 2,500 copies/ml (by bDNA: Bayer v3.0/Chiron v3.0 or PCR:Roche Amplicor
Monitor/COBAS v1.5)

Exclusion Criteria:

- Pregnancy, breast-feeding or planned pregnancy

- Likelihood of poor protocol follow-up or if Mega-Art is not feasible (due to
significant intolerance of many ARV drugs)

- Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening

- Likelihood of early death due to non-HIV disease