HIV CONNECT Collaborative Trials Group in Europe, Australia and Canada

Announces INITIO Trial to Compare Initial and Subsequent HIV Treatment Strategies

HIV CONNECT announce a new international study which has started and will compare treatment strategies for people living with HIV who are starting anti-HIV treatment. The study will be supported by Agence Nationale Recherches sur le Sida (ANRS), France; Medical Research Council (MRC), UK; National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia; Instituto Superiore di Sanita, Rome, Italy and Copenhagen HIV Programme, Denmark, and is being conducted in collaboration with Bristol-Myers Squibb Pharmaceuticals, DuPont Pharmaceuticals, GlaxoWellcome, Merck and Co., Inc., F.Hoffmann La Roche, Roche Molecular Sciences and VIRCO.

Although there have been major advances in the treatment of HIV infection in recent years several questions remain about the tolerance and potency of current triple regimens based on NRTIs and either a PI or NNRTI.

The study called INITIO will compare different strategic approaches to first-line and second-line combination antiretroviral therapies for the treatment of HIV-1 infection. Participants are randomised to open treatment where both patient and their carers know the treatment regimen.

INITIO is an open randomised three-year study and will include approximately 1,000 participants from clinical centres in Europe (Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, Switzerland and the UK), Australia, New Zealand and Canada.

Participants choosing to enter this study initially receive treatments from the NRTI* class (both ddI + d4T) plus the NNRTIf efavirenz (EFV) or the protease inhibitor nelfinavir (NFV) or both efavirenz and nelfinavir. If the therapy fails, the initial treatment will be stopped and a second regimen treatment started:

(1) ddI + d4T + EFV is followed by AZT + 3TC + ABC + NFV.

(2) ddI + d4T + NFV is followed by AZT + 3TC + ABC + EFV.

(3) ddI + d4T + EFV + NFV is followed by AZT + 3TC + ABC + RTV + SQV.

Recruitment of patients into the trial is planned to take up to one year with the main efficacy measures being changes in CD4 cell count and the proportion of patients with plasma HIV RNA below 50 copies/ml at three years following trial entry.

Taking part in this trial gives people living with HIV the opportunity of benefiting from some of the latest and most effective treatment options in HIV therapy. Although individual responses cannot be guaranteed, close monitoring will take place for changes in health status and HIV viral load using the most sensitive tests available. Selection of therapy for those needing a third regimen will be based on results of a new test showing whether the HIV virus has developed resistance to the prior anti-HIV drugs.

Drug key:

*NRTI’s: ddI = didanosine, d4T = stavudine, ZDV = zidovudine (AZT), 3TC = lamivudine, ABC = abacavir

fNNRTI’s: EFV = efavirenz

PI: NFV = nelfinavir, RTV = ritonavir, SQV = saquinavir

For more information contact: The Chairmen of the INITIO Co-ordinating Committee – Professor David Cooper and Professor Patrick Yeni, c/o The MRC Clinical Trials Unit, at the e-mail address: