A Study of Zidovudine Plus Interleukin-2 in HIV-Infected Patients Who Have No Symptoms of Infection But Who Have Tender Lymph Nodes

Summary

AMENDED: To investigate whether subcutaneous (SC) injection of IL-2 produces biological responses which parallel those observed with IV dosing. Original design: To evaluate the short-term effects of combined administration of zidovudine (AZT) and increasing doses of recombinant interleukin-2 (aldesleukin; IL-2) in patients infected with HIV, who have lymphadenopathy, but who are otherwise asymptomatic (no other symptoms). The first phase of this clinical trial will establish maximum tolerated dose ( MTD ). How quickly the drugs get into the blood and how long they remain there (pharmacokinetics) will also be studied at each dose as well as the effect on HIV. Since AZT has no effect on cells that contain inactive virus (latently infected cells) and these cells may act as viral reservoirs, that a second agent that can destroy these infected cells would be useful in combination with AZT. The different activities of AZT and IL-2, as well as the non-overlapping nature of their mechanisms of action and toxicity, increase the theoretical benefits of combining AZT, a drug which has clinically significant activity in HIV-related disease but cannot eliminate infected cells, with IL-2, a drug which may enhance anti-HIV immunity, destroy chronically infected cells, and allow immune recognition of latently infected cells.

Timeline

Start

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Primary completion

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Completion

1995-02

Publications

• Background Weinhold K, Tyler D, Austin A, Lyerly K, Bolognesi D, Bartlett J. Augmentation of non-mhc restricted cellular cytotoxicities in patients receiving Zidovudine plus interleukin 2. Int Conf AIDS. 1989 Jun 4-9;5:406 (abstract no WBP330)
• Background Bartlett JA, Blankenship KD, Greenberg M, Tyler DS, Weinhold KJ. The safety of Zidovudine and interleukin 2 in asymptomatic HIV infected patients. Int Conf AIDS. 1989 Jun 4-9;5:406 (abstract no WBP325)
• Background Bartlett JA, Berend C, Petroni GR, Ottinger J, Tyler DL, Pettinelli C, Weinhold KJ. Coadministration of zidovudine and interleukin-2 increases absolute CD4 cells in subjects with Walter Reed stage 2 human immunodeficiency virus infection: results of ACTG protocol 042. J Infect Dis. 1998 Oct;178(4):1170-3. doi: 10.1086/515677.

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