|
Welcome
|
|
21 March 2013
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | news |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| TNT-1:OPTIMA (Tri-National Trial 1: Options in Management with Anti-retrovirals) - A tri-national (Canada, UK, USA) randomised controlled trial to determine the optimal management of patients with Human Immunodeficiency Virus (HIV) infection for whom first and second-line Highly Active Anti-Retroviral Therapy (HAART) has failed |
| ISRCTN | ISRCTN19619965 |
| DOI | 10.1186/ISRCTN19619965 |
| ClinicalTrials.gov identifier | NCT00050089 |
| EudraCT number | |
| Public title | TNT-1:OPTIMA (Tri-National Trial 1: Options in Management with Anti-retrovirals) - A tri-national (Canada, UK, USA) randomised controlled trial to determine the optimal management of patients with Human Immunodeficiency Virus (HIV) infection for whom first and second-line Highly Active Anti-Retroviral Therapy (HAART) has failed |
| Scientific title | |
| Acronym | OPTIMA |
| Serial number at source | JTN-43304; G9901441 |
| Study hypothesis |
The OPTIMA trial is a large-scale, multicentre, randomised controlled trial to compare the relative efficacy of two different therapeutic strategies:
1. A drug free period 2. Increasing the number of HIV drugs in treating HIV infection after the most effective drug combinations have failed. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethics approval received from the Ottawa Hospital Research Ethics Board on the 20th November 2001. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Canada, United Kingdom, United States of America |
| Disease/condition/study domain | HIV, Acquired Immune Deficiency Syndrome (AIDS) |
| Participants - inclusion criteria |
1. Signed informed consent
2. Age 18 years or more, either sex 3. HIV-1 infection confirmed by Enzyme-Linked Immuno-Sorbent Assay (ELISA) or Western Blot or detectable HIV viral load at any time 4. Failure of at least two different multi-drug regimens, which included drugs of all classes that the patient can tolerate 5. At least 3 months continuous HAART and still on treatment 6. Two most recent results (can include screening) on current Anti-Retroviral Therapy (ART) of either: 6.1. CD4 less than 100 plus plasma Viral Load (pVL) greater than 5000 copies, or 6.2. CD4 100 - 199 plus pVL greater than 10,000 copies *If VL testing available defined as either: failure to suppress pVL after 24 weeks of therapy, or rebound of at least 0.5 log10 in pVL from the nadir. In the era before pVL available defined as: a decline in the CD4 count over 50% from the peak, or progression of HIV disease. |
| Participants - exclusion criteria |
1. Pregnancy, breast-feeding or planned pregnancy
2. Likelihood of poor protocol follow-up or if Mega-ART is not feasible (due to significant intolerance of many ART drugs) 3. Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening 4. Likelihood of early death due to non HIV-disease 5. Any medical condition or current medication, in the opinion of the treating physician, which would contraindicate anti-HIV treatment as allocated in the trial Exclusion criteria for UK arm of trial added as of 07/02/2007: 1. Pregnancy, breast-feeding or planned pregnancy 2. Likelihood of poor protocol follow-up or if Mega-ART is not feasible* (due to significant intolerance of many ARV rugs) 3. Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening 4. Likelihood of early death due to non-HIV disease *Patients exempt from second part of this question if entering option 3 |
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 01/12/2007 |
| Status of trial | Completed |
| Patient information material | Patient information can be found at: http://www.optimatrial.org/ca/pdfs/brochure.pdf |
| Target number of participants | 504 (as of 07/02/2007: 390) |
| Interventions |
Please note that the anticipated end date of the trial provided at time of registration was 31/01/2007.
1. Start a standard-ART regimen (up to four HIV drugs) 2. Start a mega-ART regimen (five or more HIV drugs) 3. Interrupt ART for 12 weeks then start a standard-ART regimen (up to four HIV drugs) 4. Interrupt ART for 12 weeks then start a mega-ART regimen (five or more HIV drugs) Added as of 07/02/2007 for UK part of trial: You can now join this study in the UK in one of three ways: Option 1: As in the main OPTIMA study, you will be randomised (similar to tossing a coin or rolling a dice) to both parts of the study. You will have a drug-free period of three months, or no drug-free period and then receive either 'standard ART' or 'mega-ART treatment. Option 2: You can choose whether or not to have a drug free period, and then be randomised for how many drugs you will take. Option 3: You can choose how many drugs you will take, and then be randomised to whether you will have a drug free period or not. Sponsor for UK arm of trial: Medical Research Council (MRC) Clinical Trials Unit (UK) 222 Euston Road London NW1 2DA United Kingdom http://www.ctu.mrc.ac.uk/ |
| Primary outcome measure(s) | The time to new or recurrent AIDS-defining event or death and time to a new non-HIV related serious adverse event are main clinical outcomes. |
| Secondary outcome measure(s) |
1. Time to development of a new non-HIV related serious adverse event
2. Quality of life 3. Incidence of grade 3 or 4 clinical or laboratory adverse events 4. Changes in CD4 counts, viral load and resistance 5. Process measures including hematologic profiles, electrolytes, renal function, liver function and pancreatic function |
| Sources of funding |
1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: JTN-43304)
2. Medical Research Council (UK) (ref: G9901441) |
| Trial website | http://www.optimatrial.org/ca/ |
| Publications |
1. 2003 protocol in http://www.ncbi.nlm.nih.gov/pubmed/12865041
2. 2007 quality of life results in http://www.ncbi.nlm.nih.gov/pubmed/19430303 3. 2010 mutation frequency results in http://www.ncbi.nlm.nih.gov/pubmed/20130473 4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21483491 |
| Contact name | Dr D. William Cameron |
| Address |
The Ottawa Hospital - General Campus
501 Smyth Road Clinical Epidemiology Program, Rm. 1818 Box 228 Ottawa |
| City/town | Ontario |
| Zip/Postcode | K1H 8L6 |
| Country | Canada |
| Tel | +1 613 737 8880 |
| Fax | +1 613 737 8925 |
| bcameron@ohri.ca | |
| Sponsor | University of British Columbia (Canada) |
| Address | 2075 Wesbrook Mall |
| City/town | Vancouver |
| Zip/Postcode | V6T 1Z1 |
| Country | Canada |
| Sponsor website: | http://www.ubc.ca/ |
| Date applied | 19/01/2001 |
| Last edited | 15/11/2011 |
| Date ISRCTN assigned | 19/01/2001 |
|
|
|
|
|
| © 2013 ISRCTN unless otherwise stated. | |
|
