AEGiS-13IAC: A Randomized Trial of IL-2 Added to HAART for Primary HIV Infection.

13th International AIDS Conference

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

A Randomized Trial of IL-2 Added to HAART for Primary HIV Infection.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB541)

Hecht F, Kahn J, Chesney M, Webb M, Batya S, Busch M, Altfeld M, Grant R, Oksenberg J, McGrath M, Walker B, Levy J
F. Hecht, UCSF, Ward 84, Building 80, San Francisco General Hospital, 995 Potrero Ave, San Francisco, CA 94110, United States, Tel.: +011 (415) 476-4082 /431, Fax: +011 (415) 476-6953, E-mail: rhecht@php.ucsf.edu

BACKGROUND: Treatment of primary HIV may offer unique opportunities to preserve the capacity to mount effective cellular immune responses to HIV. We are performing a randomized trial to determine the effects on virologic and immunologic outcomes of using an immune modulatory agent, IL-2, together with antiretroviral therapy in primary HIV infection.

METHODS: Participants are recruited by the UCSF Options Project study of primary HIV and must start on treatment within 12 months of HIV seroconversion. Patients receive antiretroviral treatment (ARV) with zidovudine, lamivudine, and nelfinavir, and are randomized to receive early IL-2 (within 4 weeks of achieving an HIV-1 RNA > 500 copies/ml) or deferred IL-2 (48 weeks after HIV-1 RNA > 500 copies/ml). 7.5 million units of IL-2 are administered SQ twice daily for 5 days every 8 weeks for 6 cycles. Safety, virologic, and immunologic parameters (CD4 count, CTL responses, cellular anti-viral factor `CAF', and T-cell repertoire) are measured.

RESULTS: We report on 16 patients who have been randomized and followed at least 24 weeks, 8 in each group. All patients receiving IL-2 experienced fevers, chills, erythema, and edema. At baseline, mean CD4 cells were similar in the early and delayed IL-2 groups (493 and 471respectively). Mean baseline plasma viral loads tended to be higher in the early than the delayed IL-2 group (20.0 K and 85.9 K respectively) but this was not statistically significant (p = 0.1). At week 48 of ARV treatment the mean CD4 cell count was 1587 in the early IL-2 group and 681 in the delayed group (p = 0.004). HIV-1 RNA was > 50 copies/ml in all 6 patients in the early IL-2 group who reached 48 weeks of follow-up, and 2 of 8 patients in the delayed group had HIV RNA > 50.

CONCLUSIONS: Patients with primary infection achieve higher CD4 cell counts when IL-2 is added to HAART. Whether this will augment the immune responses to control viral replication is the basis

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, HIV Infections, CD4 Lymphocyte Count, Viral Load, Zidovudine, Interleukin-2, Lamivudine, Anti-HIV Agents, Nelfinavir, HIV, HIV Protease Inhibitors, CD4-Positive T-Lymphocytes, HIV-1 Reverse Transcriptase, HIV Seropositivity, Human
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WeOrB541