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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 |
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 AIDS Medicines |
| 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 |
| Estimated Enrollment: | 390 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | December 2006 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contacts and Locations![]() |
Show 29 Study Locations |
| Department of Veterans Affairs |
| Medical Research Council |
| Canadian Institutes of Health Research (CIHR) |
More Information
| Study ID Numbers: | 512 |
| First Received: | November 20, 2002 |
| Last Updated: | August 29, 2006 |
| ClinicalTrials.gov Identifier: | NCT00050089 |
| Health Authority: | United States: Federal Government |
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