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CSP #512 - Options in Management with Anti-Retrovirals (OPTIMA)
This study is currently recruiting patients.
| Sponsored by: | Department of Veterans Affairs Medical Research Council
Canadian Institutes of Health Research
|
|---|---|
| Information provided by: | Department of Veterans Affairs |
Purpose
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.
| Condition | Treatment or Intervention |
|---|---|
| AIDS HIV Infections |
Drug: No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART Drug: No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART Drug: Antiretroviral Drug-Free Period (ARDFP) and Standard-ART Drug: Antiretroviral Drug-Free Period (ARDFP) and Mega-ART |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
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
Expected Total Enrollment: 1700
Study start: January 2001;
Study completion: December 2004
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
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Exclusion Criteria:
Location
and Contact
Information
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