We are an organization which originates, conducts and supervises clinical research projects regarding HIV and other infectious diseases. We do it through a net of sites with high expertise within Latin America, focusing on the regional results applicability.
CICAL, by its abbreviation “Coordinación en Investigación Clínica Académica en Latinoamérica” (in English, Latin America Coordination of Academic Clinical Research”), is an initiative of “Fundación IBIS”. “Fundación IBIS”, created for HIV research, is a non-profit organization whose mission is to promote, develop and encourage clinical research and improve social and health services availability for those who need it, as well as to create genuine knowledge.
After 20 years of experience, CICAL has developed a solid position in the Region reaching the goals outlined in its Mission: the development of an own Research Plan linked to the Global Plan. This Plan is connected to the management of the Research Study Platform, promoting the expansion of research sites, both in the scientific and operative fields, through the optimization of the transfer of resources and the Ethics Committees.
Until the global pandemic of COVID-19 CICAL dedicated resources and efforts to the study of a preventive vaccine and palliative treatments for this disease. CICAL has established relationships with international clinical research networks to help generate responses to the emergence of this infectious disease.
CICAL high-quality standards has led to the achievement of goals within the Region such as drug delivery, regulatory affairs administration, trainings and courses related to clinical research, and data management.
Throughout its history, CICAL has generated and contributed to generate high-impact medical knowledge. Some of its contributions are described below:
- START Study: CICAL coordinated this study in Argentina, Chile and Mexico which became a milestone in the current evidence in relation to the therapeutic utility. It stated the benefit of the early treatment in asymptomatic patients with high levels of CD4+. http://www.nejm.org/doi/full/10.1056/NEJMoa1506816#t=abstract
- Use of Interleukine-2 (IL-2) in HIV-infected patients with the objective of promoting the greatest and quickest recovery of the immune system. CICAL conducted the Vanguard Study in Argentina which contributed to specify the effect of IL-2 in the amplification of the T-CD4+ lymphocytes number in patients under antiretroviral treatment. Moreover, CICAL definitely contributed to the design, implementation and conduction of ESPRIT and SILCAAAT studies which showed that the clinical use of IL-2 did not produce any anticipated benefit in the morbimortality of HIV-infected patients, challenging the CD4+ counts in the context of a therapeutic immunologic intervention.
- SMART Study. CICAL was in charge of the management of SMART Study in Argentina, Chile and Uruguay. This study defined the greatest clinical risk of the interruption of the antiretroviral treatment, engendering a new paradigm as regards the understanding of the retroviral infection as an inflammatory process whose persistence leads to the appearance of chronic illnesses. The connection to HIV of said illnesses has not been known until that moment.
- Generation of clinical data of patients with HIV in Latin America. CICAL is the main supporter and organizer of LATINA Cohort which captures information in multi-sites within the Region prospectively.
- The implementation of the MOSAICO study and HPTN 083 signifies an important advance in the field of HIV research. Both studies investigate the efficacy and subsequent implementation of drugs to prevent HIV: the first one works on a preventive vaccine and the second on preventive injections.
- The ENSEMBLE study was an important precursor as the efficacy of one of the COVID-19 vaccines was demonstrated. The vaccine sponsored by Jonson & Jonson, is characterized by being constituted by a single dose of Ad26.COV2.S and has efficacy of 66.1% mild cases 28 days after vaccination, 85.4% severe cases 28 days after vaccination, 92.4% severe cases 42 days after vaccination and 64.0% (mild cases) and 81.7% (severe cases) versus the South African variant 28 days after vaccination.
Currently, CICAL coordinates more than ten studies regionally in the Infectious Area not only for HIV but also for COVID 19.