Introduction

The project currently being promoted by the Icona Foundation was born as a direct follow-up of the Icona study. The Icona study began in 1997 as an observational study conducted on a wide cohort of HIVpositive individuals. It is a study that incorporates various innovative elements. The Icona survey consists of more than 6,000 HIV-positive individuals enrolled between April 1, 1997 and December 16, 2006 by the 71 Centres operating throughout Italy and coordinated by 6 University Centres. The only eligibility criterion for participants was that they must never have taken antiretroviral medication. Icona was therefore born as a national cohort of subjects who were “naïve” to antiretroviral therapy.

ICONA, a unique cohort in the world

Today Icona joins other prestigious European and American cohorts, with whom it collaborates on international research projects and represents the first wide-scale, multi-centre study experience based on the use of an IT network fuelled by and accessible to both basic research groups and clinical practices. Icona stands apart as the only cohort in the world capable of supplying reliable data on the impact of initial treatments on epidemiological, clinical, biological, and behavioral parameters:

• For the amount and type of HIV-positive individuals: more than 6000 antiretroviral naive patients at the beginning of the observation period
• For the length of the observation period: ten years have already passed for the first patients enrolled
• For considering all aspects of HIV-positive individuals and lifestyles: this cohort is evaluated not only for drug effectiveness and tolerability, but also for issues related to being HIV-positive and the environment with which HIV-positive individuals interact
• For the biological samples bank: 25,122 plasma samples and 8,740 cell samples.

In the end, ICONA is an example of a successful collaboration between private industry and public bodies with the objective of:

• promoting scientific research
• improving clinical practice
• identifying the overall needs of HIV-positive individuals

ICONA, the confirmation of scientific leadership

The results obtained in the first decade of activities in terms of scientific publications, nested studies, communications at international conferences, and collaborations with other international cohorts (Eurosida, D:A:D, ART COHORT, Plato, RDI) confirm the scientific leadership of the project and the potential of Italian infectivology.

Publications and presentations

• 94 publications in international journals
• 11 publications in national journals
• 99 presentations at international conferences
• 24 presentations at national conferences

Principal nested studies

• BEHEPI, coordinator E. Girardi
• AdICoNA, coordinator A. Antinori
• LipoICoNA, coordinator M.Galli
• HepaICoNA, coordinator M. Puoti

Up until today, the Icona project has made it possible to obtain information on:

• Analyses on the progress of the HIV infection from the beginning of treatment with antiretroviral medications prescribed according to Centre indications;
• Frequency and motivation for the withdrawal of the first antiretroviral drug treatment;
• Methods of access to antiretroviral therapies in relation to behavioral and clinical variables;
• Adherence to antiretroviral therapies in relation to demographic, behavioral, and clinical variables;
• The frequency of HIV mutants resistant to antiretroviral drugs in the naïve population that must begin an antiretroviral treatment, and predictability of same on the virological outcome of the treatment.
• The role of ancillary mutations of the pol gene in the modulation of drug-resistance and in influencing the therapeutic response.
• The identification of clinical, therapeutic, and genetic factors that determine the metabolic toxicity of medications and lipodystrophy.
• Collaboration with the D:A:D: study, promoted by the EMEA, together with other international cohorts, with the objective of verifying the risk of cardiovascular events over the course of antiretroviral therapy on more than 15,000 patients.

The new Project

Since July 1, 2007, Icona has launched a follow-up to the previous project under the management of the ICONA FOUNDATION, which has acquired full ownership of the database compiled up to that date.

The ICONA FOUNDATION will be entrusted by Statute to the National Scientific Community and managed by a Board of Directors consisting of Members designated by the Rectors of Universities.

The potential of the project is therefore vast and diversified and may be further amplified by including the collection of biological materials for targeted studies.

ICONA, a national resource

As is known, the incidence of HIV infection is unlikely to fade away. It is estimated that there are 130,000-140,000 HIV+ individuals currently in Italy and that this number increases by approximately 3,500–4,000 new infections per year. Success stories of anti-HIV drugs have reduced the AIDS mortality rate from 100% to 8-9% - more than any one could have ever hoped for. Therefore, HIV infection today is now a chronic and treatable health problem, but unfortunately remains incurable. Individuals being treated number more than 55,000 and this number is destined to rise.

Numerous issues remain unsolved:

• Risk perception has been dangerously reduced. This results in insufficient testing and the consequential discovery of HIV-positive status years after the original infection.
• Epidemiological data indicate sexual transmission as the primary cause of infection with the extension of risk to all sexually active age groups.
• The average age of HIV+ individuals being treated is estimated to be about 30-40. For these patients, therapy is expected to last for another 30-40 years. Critical aspects, which are already evident today, include the capacity of patients to follow prescriptions, the selection of resistant mutant viruses, and chronic toxicity.
• In addition to health problems, AIDS has always gone hand-in-hand with social, ethical, and economic issues.
• Costs for assisting HIV+ individuals are rising steadily.
• The availability of new drugs gives rise to the problem of correct use. Organized volunteer groups are present, active, and competent.

The I.Co.N.A. cohort, together with the Master cohort, has been and will continue to be an indispensable source of knowledge and interest for Doctors and Researchers, as well as for Institutions and Pharmaceutical Industries.

For this reason, the Foundation intends to maintain and develop this national resource in synergy with other national and international observational cohorts.