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| Sponsors and Collaborators: |
Department of Veterans Affairs Medical Research Council Canadian Institutes of Health Research (CIHR) |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00050089 |
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 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.
| Condition | Intervention |
|---|---|
|
AIDS HIV Infections |
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP Drug: Standard ART vs Mega ART |
| Study Type: | Interventional |
| Study Design: | Active Control |
| 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 |
| Enrollment: | 288 |
| Study Start Date: | January 2001 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART
|
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interuption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
|
2: Active Comparator
No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART
|
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interuption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
|
3: Active Comparator
Antiretroviral Drug-Free Period (ARDFP) and Standard-ART
|
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interuption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
|
4: Active Comparator
Antiretroviral Drug-Free Period (ARDFP) and Mega-ART
|
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interuption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
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:
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.
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 30 Study Locations| Study Chair: | Sheldon Brown | VA Medical Center, Bronx |
More Information
| Responsible Party: | Department of Veterans Affairs ( Brown, Sheldon - Study Chair ) |
| Study ID Numbers: | 512 |
| Study First Received: | November 20, 2002 |
| Last Updated: | October 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00050089 History of Changes |
| Health Authority: | United States: Federal Government |
|
AIDS antiretrovirals ART drug-free period HAART |
HIV human immunodeficiency virus randomized structured treatment interruptions |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
