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11 February 2012
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| [ Print-friendly version ] |
| An open randomised trial to evaluate different therapeutic strategies of combination therapy for human immunodeficiency virus (HIV-1) Infection |
| ISRCTN | ISRCTN44582462 |
| ClinicalTrials.gov identifier | |
| Public title | An open randomised trial to evaluate different therapeutic strategies of combination therapy for human immunodeficiency virus (HIV-1) Infection |
| Scientific title | |
| Acronym | INITIO |
| Serial number at source | NA |
| Study hypothesis | To compare in patients starting therapy for HIV infection, the activity of three strategies for using anti-retroviral regimens for at least three years in terms of the effects on CD4 cell counts, plasma HIV RNA, viral resistance, progression of HIV disease and survival. |
| Lay summary | |
| Ethics approval | Protocol approved in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, Switzerland, UK, Australia, New Zealand, Canada and Brazil. |
| Study design | Randomised controlled trial |
| Countries of recruitment | International |
| Disease/condition/study domain | HIV-1 infection |
| Participants - inclusion criteria | The participants in the trial must be HIV-1 infected, over 18 years of age, at any stage of HIV disease, but not acute symptomatic primary infection, where anti-retroviral therapy is indicated. Participants should be likely to take their first regimen for at least 6 months and be expected to adhere to the protocol. |
| Participants - exclusion criteria | The participants must not have received prior treatment with antiretroviral drugs or immunotherapy. There must be no history of peripheral neuropathy or pancreatitis. Individuals must not be receiving combination cytotoxic chemotherapy for cancer or parental therapy for an active opportunistic infection. Women should not be pregnant, breastfeeding or unwilling to use adequate contraception. Participants will be ineligible if biochemistry and haematology blood results from screening are outside the trial upper safety limits. |
| Anticipated start date | 01/03/1999 |
| Anticipated end date | 31/03/2001 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1000 |
| Interventions |
Randomisation of approximately 1000 participants, from 17 countries worldwide, to one of three drug regimens:
1. 2 NRTIs plus a NNRTI 2. 2 NRTIs plus a PI 3. 2 NRTIs plus a NNRTI and PI Quality of life substudy: Quality of life questionnaires to be completed by participants consenting to this substudy in participating countries. Virology substudy: Participants joining this substudy at participating sites will have plasma and cells taken for storage for further study. Immunology substudy: Participants joining this substudy from specified clinics, within 6 hour delivery time of the centralised immunology labs in 5 countries, UK, France, Australia, Switzerland and Italy will have additional blood samples taken for detailed lymphocyte phenotypes, lymphoproliferative assays and CD8 T-cell specific activity. In addition a tetanus toxoid vaccination will be given at week 24 for research purposes. Lipodystrophy substudy: Participants for this substudy will be recruited from Australia and at baseline, every 12 weeks and at first therapeutic failure, a patient assessment of body changes, fasting insulin, C-Peptide, fibrogen and plasminogen activator inhibitor and exercise level assessment will be taken. At baseline, every 24 weeks and at therapeutic failure a record will be made of: DEXA scan, single cut abdominal computed tomography (CT) scan, standardised anthropometry and an electrocardiogram (ECG). |
| Primary outcome measure(s) |
1. Change in CD4 cell count between 2 and 3 years
2. The proportion of patients with plasma HIV RNA below 50 copies/ml at 3 years |
| Secondary outcome measure(s) |
1. Change in CD4 cell count between 2 and 3 years
2. Change in plasma HIV RNA at 3 years 3. The time on first regimen 4. Time on second regimen (where applicable) 5. The time to first plasma HIV RNA below 50 copies/ml 6. Phenotypic and genotypic drug resistance at 3 years 7. Progression of HIV disease (including death) |
| Sources of funding |
The trial was supported with respect to funding, antiretroviral drugs, viral load assays and resistance assays by:
1. Dupont 2. Hoffman-La Roche 3. Merck 4. Bristol Meyers Squibb 5. Medical Research Council 6. GlaxoSmithKline 7. Virco |
| Trial website | http://www.ctu.mrc.ac.uk/initio/ |
| Publications | Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16860698 |
| Contact name | Prof Abdel Babiker |
| Address |
MRC CTU
222 Euston Road |
| City/town | London |
| Zip/Postcode | NW1 2DA |
| Country | United Kingdom |
| Sponsor | Medical Research Council (UK) |
| Address | 20 Park Cresent |
| City/town | London |
| Zip/Postcode | W1B 1AL |
| Country | United Kingdom |
| Date applied | 06/09/2005 |
| Last edited | 10/08/2007 |
| Date ISRCTN assigned | 28/09/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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