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CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA) Clinical research trials and CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA) health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA). CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA) clinical trial. Subjects frequently get the best healthcare possible for their CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA) condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)  CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)
CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)
For Condition: HIV Infections,AIDS
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,Medical Research Council,Canadian Institutes of Health Research
Synopsis: This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional HAART (Highly Active Antiretroviral Therapy) 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 3.5 years with 2.5 years of intake and 1 year (minimum) of follow-up; median duration of patient follow-up is 2 years. The target sample size is 1700 patients and will provide 80% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Seventy-seven sites will be participating in the trial--30 VA, 25 UK and 22 Canada.
Details: Primary Hypothesis: Compared to patients in Standard Antiretroviral Therapy (ART), patients in Mega-ART assuming full compliance, will experience a 30% reduction in the hazard of reaching a clinical endpoint (AIDS event or death). Secondary Hypotheses: Time to development of a new, non-HIV related serious adverse event, health related quality of life, the incidence of grade 3 or 4 clinical or laboratory adverse events and changes in virological and immunological markers (CD4 cell count, viral load, resistance profiles) will vary between the different treatment strategies. Primary Endpoint: 1. Time to development of a new or recurrent AIDS event, or time to death Secondary Endpoint: 1. Time to development of a new non HIV-related serious adverse event Other Outcomes: 1. Quality of life 2. Incidence of grade 3 or 4 clinical or laboratory adverse events 3. Changes in CD4 counts, viral load, resistance patterns 4. Process measures including hematologic profiles, electrolytes, renal, liver and pancreatic function and lipid levels. Interventions: Eligible patients will be randomized to one of four treatment strategy arms: a. No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART b. No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART c. Antiretroviral Drug-Free Period (ARDFP) and Standard-ART d. Antiretroviral Drug-Free Period (ARDFP) and Mega-ART Note: The 'first' randomization will be ARDFP vs No ARDFP. Patients randomized to No ARDFP will receive their 'second' randomization at the same time. However, patients randomized to an Antiretroviral Drug Free Period (ARDFP) will receive their 'second' randomized assignment (Standard or Mega-ART) at the end of the ARDFP. Study Abstract: This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional HAART (Highly Active Antiretroviral Therapy) 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 3.5 years with 2.5 years of intake and 1 year (minimum) of follow-up; median duration of patient follow-up is 2 years. The target sample size is 1700 patients and will provide 80% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Seventy-seven sites will be participating in the trial--30 VA, 25 UK and 22 Canada. This is the first trial of a Tri-National collaboration effort between the UK MRC, the Canadian CIHR and the VA CSP. The OPTIMA Trial was reviewed and approved by CSEC on October 12, 2000. The pre-kickoff meeting was held on March 21, 2001 in Washington, DC. The VA study kickoff meeting was held in Dallas, TX on May 16-18, 2001 and the Canadian kickoff was held in Toronto on May 29, 2001. The UK will have individual site initiation. As of October 16, 2002 there have been 136 patients enrolled in OPTIMA, at 60 sites in the three countries (110 in the VA, 19 in Canada and 7 in the UK). To date there are 60 sites actively participating in the study (25 in the VA, 15 in UK and 20 in Canada).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 1700
Location and Contact Information:
VA North Texas Health Care System *Recruiting*
Dallas, Texas, 75216
United States
Recruiting David Margolis 214-857-0410
Decatur Veterans Affairs Medical Center (111) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting David Rimland 404-321-6111
VA Maryland Health Care System *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Anthony Amoroso 410-605-7199
Phoenix VAMC (ACS/11C-1) *Recruiting*
Phoenix, Arizona, 85012
United States
Recruiting Chris Reust 602-277-5551
Bay Pines VAMC (111J) *Recruiting*
St. Petersburg, Florida, 33708
United States
Recruiting David Johnson 727-398-6661
San Juan VAMC *Recruiting*
San Juan, , 00927-5800
Puerto Rico
Recruiting Carlos Rivera-Vazquez 787-641-2904
Cincinnati VAMC *No longer recruiting*
Cincinnati, Ohio, 45220
United States
No longer recruiting
Durham VA Medical Center (111H) *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Kenneth Wilson 919-286-0411
VAMC Gainesville (182) *Recruiting*
Gainesville, Florida, 32608-1197
United States
Recruiting Bradley Bender 352-374-6114
East Orange VAMC (111-ID) *Recruiting*
East Orange, New Jersey, 07018-1095
United States
Recruiting Lisa Dever 973-676-1000
VA Long Beach Healthcare System *Recruiting*
Long Beach, California, 90822
United States
Recruiting Rodney Wishnow 562-494-2611
San Antonio VAMC Room 111F *Recruiting*
San Antonio, Texas, 78284
United States
Recruiting Raymond Chung 210-617-5300
Houston VAMC (111-G) *Recruiting*
Houston, Texas, 77030
United States
Recruiting Maria Rodriguez-Barradas 713-794-8856
Dorn VAMC (151) *Recruiting*
Columbia, South Carolina, 29209-1639
United States
Recruiting Stephen Hawes 803-776-4000
WLA, VA Medical Center (111F) *Recruiting*
Los Angeles, California, 90073
United States
Recruiting Matthew Goetz 310-268-3015
VA Connecticut HCS *Recruiting*
West Haven, Connecticut, 06516
United States
Recruiting Michael Rigsby 203-937-3446
Boston VAMC (7B-60) *Recruiting*
Boston, Massachusetts, 02130
United States
Recruiting Catherine Fleming 617-232-9500
Cleveland VAMC *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Robert Bonomo 216-791-3800
Portland VA Medical Center *Recruiting*
Portland, Oregon, 97207
United States
Recruiting Thomas Ward 503-220-8262
Bronx VAMC (111F) *Recruiting*
Bronx, New York, 10468
United States
Recruiting Douglas Finch 718-584-9000
Philadelphia VA Medical Center (111-ID) *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Joel Maslow 215-823-5847
Edward Hines, Jr. Hospital (111-P) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Constance Pachucki 708-202-2763
Ann Arbor VAMC *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting Sandro Cinti 734-769-7100
West Chicago VAMC *Terminated*
Chicago, Illinois, 60612
United States
Terminated
W. Palm Beach VAMC *Terminated*
West Palm Beach, Florida, 33410
United States
Terminated
Palo Alto VA HCS (132) *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Mark Holodniy 650-493-5000
VAMC Miami (111-I) *Recruiting*
Miami, Florida, 33125
United States
Recruiting Nancy Klimas 305-324-4455
San Diego VAHCS (9-111F) *Recruiting*
San Diego, California, 92161
United States
Recruiting David Looney 858-552-8585
NY Harbor Healthcare System *Terminated*
New York City, New York, 10010
United States
Terminated
Additional Information:
Study ID Numbers: 512;
Study Start Date: January 2001
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050089
Other Hiv Infections Studies:
1. A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients with AIDS
2. A Study of ddI in Patients with AIDS Who Become Sicker While Taking Zidovudine
3. A Study of ALRT 1057 Topical Gel in Patients with AIDS-Related Kaposi's Sarcoma
4. An HIV Vaccine Preparedness Study
5. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)
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