Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050089
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2002-11-20
Brief Title:
CSP 512 - Options in Management With Anti-Retrovirals
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 512 - Options in Management With Anti-Retrovirals OPTIMA Management of Patients With HIV Infection for Whom First and Second-line Highly Active Anti-Retroviral Therapy Has Failed
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMA
Brief 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 65 years with 5 years of intake and 15 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
Detailed Description:
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
Interventions
Eligible patients will be randomized to one of four treatment strategy arms
1 No Antiretroviral Drug-Free Period No ARDFP and Standard-ART
2 No Antiretroviral Drug-Free Period No ARDFP and Mega-ART
3 Antiretroviral Drug-Free Period ARDFP and Standard-ART
4 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
Note All Serious Adverse Events were coded using the MedDRA coding dictionary other not serious Adverse Events were collected as part of the study but were not coded using MedDRA or any other standardized coding dictionary
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 17 2005 there have been 357 patients enrolled in OPTIMA at 64 sites in the three countries 279 in the VA 41 in Canada and 37 in the UK To date there are 64 sites actively participating in the study 24 in the VA 19 in UK and 21 in Canada Last date of patient follow-up was December 31 2007
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
Interventions
Eligible patients will be randomized to one of four treatment strategy arms
1 No Antiretroviral Drug-Free Period No ARDFP and Standard-ART
2 No Antiretroviral Drug-Free Period No ARDFP and Mega-ART
3 Antiretroviral Drug-Free Period ARDFP and Standard-ART
4 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
Note All Serious Adverse Events were coded using the MedDRA coding dictionary other not serious Adverse Events were collected as part of the study but were not coded using MedDRA or any other standardized coding dictionary
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 17 2005 there have been 357 patients enrolled in OPTIMA at 64 sites in the three countries 279 in the VA 41 in Canada and 37 in the UK To date there are 64 sites actively participating in the study 24 in the VA 19 in UK and 21 in Canada Last date of patient follow-up was December 31 2007
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None