Fifth International Congress Drug Therapy in HIV Infection 22-26 October, 2000 Glasgow, UK

A RANDOMIZED CONTROLLED PHASE II STUDY OF HIGHLY ACTIVE ANTIRETROVIRAL THERAPY (HAART) WITH INTERMITTENT INTERLEUKIN-2 (IL-2) BY CONTINUOUS IV (CIV) OR SUBCUTANEOUS (SC) ROUTES IN HIV-INFECTED PATIENTS WITH CD4⁺ COUNTS 50–350 CELLS/MM³: ACTG 328-RESULTS AT 60 WEEKS

R. Mitsuyasu, R. Pollard, R. Gelman, D.Weng
for the ACTG 328 protocol team

Int Cong Drug Therapy HIV 2000 Oct 22-26;5:Abstract No. PL7.5
AIDS 2000, Oct 22-26;14(Suppl. 4); S9

The objectives of this study were to ascertain the effects of IL-2 given by either CIV or SC routes added to HAART versus HAART alone on CD4 response, immune phenotype and function, antiviral effectiveness of HAART, tolerability and quality of life in patients with advanced HIV. Two hundred and four protease inhibitor-naïve patients (CD4 50–350) were treated with HAART alone (indinavir + 2 nucleoside analogues) for 12 weeks. If HIV RNA < 5000 c/ml at week 12, patients were randomized to HAART alone (n = 52), HAART + CIV IL-2 at 9MIU qd × 4d q8weeks (n = 54), or HAART + SC IL-2 at 7.5 MIU bid × 5d q8 weeks (n = 55) for up to 84 weeks. Patients on CIV could switch to SC IL-2 after3 or 6 cycles if CD4 > 25% and > 100 cells above week 12 baseline. IL-2 dose reduction was allowed in both IL-2 arms for toxicities or poor tolerance. Primary endpoint was the proportion of patients at week 60 with > 50% rise in CD4 count above week 12 baseline. Immunologic and virologic changes were assessed in the three arms every 8 weeks. 39/54 (72%) in CIV and 36/55 (65%) in SC completed at least six cycles of IL-2 with 40/54 (74%) crossing over to SC after three or six cycles. Median daily doses of IL-2 were 9.3 MIU/d in CIV and 8l7 MIU/d in SC arms. IL-2 was associated with more fatigue, fever, nausea, vomiting and hyperbilirubinemia. Changes from baseline to week 60 were as follows (Table F553).

Significant increases in CD4⁺ counts were seen with both CIV and SC IL-2 compared to HAART alone after 60 weeks of therapy. IL-2 did not appear to increase or decrease the proportion of patients with plasma RNA < 50 copies/ml after 60 weeks of initial HAART therapy. An early trend to somewhat lower occurrence of AIDS-defining illnesses was observed in IL-2 treated patients, although the study was not designed to detect this difference. Additional clinical and immunologic and virologic follow-up of these patients is in progress.

Presenting author: R. Mitsuyasu

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2000-10-22
PL7-5

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