CSP #512 - Options in Management With Anti-Retrovirals
Completed · Not applicable
Conditions studied: AIDS, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00050089
- Run by
- US Department of Veterans Affairs
- People needed
- 368
- Starts
- 2001-01-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2015-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
- VA Medical Center, Long Beach — Long Beach, California, United States
- VA Palo Alto Health Care System — Palo Alto, California, United States
- VA San Diego Healthcare System, San Diego — San Diego, California, United States
- VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States
- VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
- VA Medical Center, DC — Washington D.C., District of Columbia, United States
- North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
- VA Medical Center, Miami — Miami, Florida, United States
- Bay Pines VAMC (111J) — St. Petersburg, Florida, United States
- West Palm Beach VA Medical Center — West Palm Beach, Florida, United States
- Atlanta VA Medical and Rehab Center, Decatur — Decatur, Georgia, United States
- Jesse Brown VAMC (WestSide Division) — Chicago, Illinois, United States
- Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
- VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
- VA Medical Center, Jamaica Plain Campus — Boston, Massachusetts, United States
- VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States
- VA New Jersey Health Care System, East Orange — East Orange, New Jersey, United States
- New York Harbor HCS — New York, New York, United States
- VA Medical Center, Bronx — The Bronx, New York, United States
- VA Medical Center, Durham — Durham, North Carolina, United States
- VA Medical Center, Cincinnati — Cincinnati, Ohio, United States
- VA Medical Center, Cleveland — Cleveland, Ohio, United States
- VA Medical Center, Portland — Portland, Oregon, United States
- VA Medical Center, Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.