CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA)
AIDS, HIV Infections
About this trial
This is an interventional treatment trial for AIDS focused on measuring AIDS, antiretrovirals, ART, drug-free period, HAART, HIV, human immunodeficiency virus, randomized, structured treatment interruptions
Eligibility 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
Sites / Locations
- Carl T. Hayden VA Medical Center
- VA Medical Center, Long Beach
- VA Palo Alto Health Care System
- VA San Diego Healthcare System, San Diego
- VA Greater Los Angeles Healthcare System, West LA
- VA Connecticut Health Care System (West Haven)
- VA Medical Center, DC
- North Florida/South Georgia Veterans Health System
- VA Medical Center, Miami
- Bay Pines VAMC (111J)
- West Palm Beach VA Medical Center
- Atlanta VA Medical and Rehab Center, Decatur
- Jesse Brown VAMC (WestSide Division)
- Edward Hines, Jr. VA Hospital
- VA Maryland Health Care System, Baltimore
- VA Medical Center, Jamaica Plain Campus
- VA Ann Arbor Healthcare System
- VA New Jersey Health Care System, East Orange
- VA Medical Center, Bronx
- New York Harbor HCS
- VA Medical Center, Durham
- VA Medical Center, Cincinnati
- VA Medical Center, Cleveland
- VA Medical Center, Portland
- VA Medical Center, Philadelphia
- WJB Dorn Veterans Hospital, Columbia
- VA North Texas Health Care System, Dallas
- Michael E. DeBakey VA Medical Center (152)
- VA South Texas Health Care System, San Antonio
- VA Medical Center, San Juan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
No ARDFP+Standard-ART
No ARDFP+Mega-ART
ARDFP+Standard-ART
ARDFP+Mega-ART
No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART
No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART
Antiretroviral Drug-Free Period (ARDFP) and Standard-ART
Antiretroviral Drug-Free Period (ARDFP) and Mega-ART