AEGiS-13IAC: Randomised study of intermittent subcutaneous interleukin-2 (IL-2) therapy without anti-retrovirals versus no treatment.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Randomised study of intermittent subcutaneous interleukin-2 (IL-2) therapy without anti-retrovirals versus no treatment.

Int Conf AIDS 2000 Jul 9-14; 13:24 (abstract no.. LbOr28)

Youle M, Fisher M, Nelson M, Dykhoff A, Doggett TA, Richardson C, Janossy G, Loveday C, Sullivan A, Johnson M, Tavel J, Fosdick L, Emery S
Royal Free Centre for HIV Medicine, Royal Free Hospital, London, United Kingdom. Fax: +44 207 830 2201, E-mail: myoule@rfh1.demon.co.uk.

BACKGROUND: IL-2 therapy increases CD4+ cell counts (CD4) in subjects receiving anti-retroviral medication. Concern has been expressed that IL-2 alone might cause a sustained increase in HIV replication.

OBJECTIVES: This study was designed to evaluate the virological and immunological effects of IL-2 alone in anti-retroviral naive subjects with CD4>350/mm³. Design: An open-label, randomised, parallel group, study compared no treatment with IL-2 4.5 MIU or 7.5MIU q12h subcutaneously for 5 days every 8 weeks for 24 weeks. Subjects who received IL-2 could then continue cycles on request. The primary endpoints for the study were mean area under the curve (AUC) change from baseline CD4 cell count and plasma log₁₀HIV RNA.

RESULTS: 36 subjects (1 female) were enrolled. The 3 arms were well matched at baseline, with median CD4 440/mm³(nadir 39/mm³) and HIV RNA of 4.3 log₁₀copies/ml. Median follow-up was 9.8months (range 0-16) and 31/36 subjects remained on-study at week 24. Two patient randomised to receive IL-2 did not start, whilst 6 IL-2 and 1 control patients withdrew from study. Mean AUC change from baseline CD4 cell counts were significantly higher (p=0.001) in recipients of IL-2 (148 cells/mm³) compared to controls (25 cells/mm³) at week 24 and by week 48 the mean CD4 was 656 (+232) cells/mm³ and 44 (+13) cells/mm³ (p=0.02) respectively. Mean plasma HIV RNA levels during follow-up and mean AUC change from baseline plasma HIV RNA were not significantly different between treatment arms. Six endpoints occurred in the control group versus 2 in the IL-2 group.

CONCLUSION: This study suggests that cyclical IL-2 therapy produces sustained and significant rises in CD4 without sustained increases in HIV replication when given without anti-retrovirals to individuals with CD4 cell counts >350/mm³.

Keywords: AEGIS, CD4 Lymphocyte Count, Interleukin-2, HIV Infections, Antiretroviral Therapy, Highly Active, Drug Therapy, Combination, HIV Seropositivity, Case-Control Studies, Female, Human, therapy, drug therapy, AIDS
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