CSP #512 - Options in Management With Anti-Retrovirals
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
US Department of Veterans Affairs VA Office of Research and Development
Collaborators:
Canadian Institutes of Health Research (CIHR) Medical Research Council