AEGiS-15IAC: Estimation of clinical events in the control arm of the ESPRIT trial based on data from an observational database.

15th International AIDS Conference


Bangkok, Thailand - July 11-16, 2004

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Estimation of clinical events in the control arm of the ESPRIT trial based on data from an observational database.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. B10257)

Lundgren JD
Copenhagen HIV Programme, Copenhagen, Denmark

BACKGROUND: The efficacy of interleukin-2 boost of the CD4 count is currently tested in controlled trials designed to show improved clinical outcome - the ESPRIT and SILCAAT trials. Observational studies provide a valuable source for estimating clinical event rates for controlled trials, although issues to consider in this respect include comparable definitions of endpoints, selection criteria, and possible a bias in trials to select more healthy subjects.

METHODS: Patients in the EuroSIDA database were selected to mimic the profile of patients included in either of the two trials, i.e. the first visit after 1/1 1998 with a CD4 count >300 cells/muL and a HIV-RNA value available (for ESPRIT) or 2 CD4 counts between 50-300 cells/muL and HIV-RNA< 4 log10 copies/mL (for SILCAAT), no AIDS defining events in the last 12 months, and receiving at least two NRTI's. This was defined as the baseline visit. Characteristics at baseline and event rates thereafter were compared with trial data (data for SILCAAT not presented as assessment of quality of clinical events not completed yet). Of note, the clinical outcome in ESPRIT is not stratified for whether patients are assigned to receive interleukin-2 or not.

RESULTS: The 4,649 patients ESPRIT-like patients in EuroSIDA had a comparable baseline demographic profile to the 4,150 patients at baseline in ESPRIT. The CD4 count (% with HIV-RNA< 400 copies/mL) at baseline was 393 (58%) and 459 (65%) cells/muL, respectively.

Keywords: AEGIS, CD4 Lymphocyte Count, Anti-HIV Agents, Acquired Immunodeficiency Syndrome, HIV, HIV Infections, Fatty Acids, Omega-3, HIV Protease Inhibitors, HIV Seropositivity, Interleukin-2, Esapent, Humans, prevention & control

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B10257

Copyright © 2004 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.