SILCAAT

SILCAAT

Subcutaneous, Recombinant, Human Interleukin-2 in HIV-Infected Patients with Low CD4+ Counts Under Active Antiretroviral Therapy. An international, multicentre, Phase-3 clinical trial that examined whether IL2 plus combination antiretroviral therapy in adults with advanced HIV infection would reduce the risk of AIDS-associated opportunistic diseases or death more effectively than combination antiretroviral therapy alone.

Conclusion
While the CD4+ T-cell counts (a surrogate marker of participants who received IL2) rose an average of 59 cells/mm3 higher than those of participants in the control group—a statistically significant difference—the elevation did not offer any health advantage to HIV-infected individuals.
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References in periodicals archive ?
INSIGHT-ESPRIT Study Group, SILCAAT Scientific Committee; Abrams D, Levy Y, Losso MH, Babiker A, Collins G, Cooper DA, et al.
Achhra AC, Amin J, Law MG, et al; INSIGHT ESPRIT & SILCAAT study groups.
Two DAD Study analyses, (2,20) a EuroSIDA review, (1) the SMART cardiovascular endpoint dissection, (3) and a combined analysis of the ESPRIT and SILCAAT interleukin 2 (IL-2) trials (37) discerned no link between CD4 count (measured various ways) and risk of cardiovascular disease (also measured various ways) (Table 1).
I think the results of the SILCAAT and ESPRIT studies reported in this issue of the Journal of HIV Therapy would have surprised many of the early workers greatly.
The Phase III trials, known as the ESPRIT and SILCAAT studies, were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and funded respectively by NIAID and Chiron Corp.
Announced an agreement in principle with the investigators of SILCAAT, a Phase III study for IL-2 in patients with HIV, to transfer the trial to the Scientific Committee.
INSIGHT-ESPRIT Study Group; SILCAAT Scientific Committee, Abrams D, Levy Y, Losso MH, et al.
BACKGROUND: RATIONALE FOR THE SILCAAT AND ESPRIT TRIALS
The 6000-person ESPRIT and SILCAAT trials reached essentially the same conclusions: (76) People taking IL-2 plus antiretrovirals gained significantly more CD4 cells early in treatment than those taking antiretrovirals alone.
The SILCAAT trial has continued while Chiron and the Scientific Committee worked on a transition plan.
1), (2) Yves Levy, who led one of the two trials, concluded that even a moderate benefit from IL-2 "can be definitively ruled out" as a result of the two trials, ESPRIT (1) and SILCAAT.
Two major studies investigate the effect of IL-2: ESPRIT (Evaluation of Subcutaneous Proleukin in a Randomized International Trial) and SILCAAT (Subcutaneous IL-2 in HIV-infected Patients with Low CD4 Counts under Active Antiretroviral Therapy).