Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
Phase I trial of rIL-3 plus zidovudine (ZDV) in HIV positive patients with neutropenia (Meeting abstract).
Proc Annu Meet Am Soc Clin Oncol; 13:A17 1994. Unique Identifier : AIDSLINE ICDB/94600014 Von Roenn JH; Gordon LI; Grace W; Anderson J; Eickhoff C; Northwestern Univ., Chicago, IL
Abstract:
HIV-infected patients (pts) develop multilineage marrow suppression which may compromise the ability to deliver optimal therapy. IL-3 is a hematopoietic growth factor which preferentially supports the proliferation of early multilineage progenitor cells. IL-3, like GM-CSF, has been shown in vitro to augment HIV expression in monocytes. This Phase I study was developed to determine the biologically active dose of rIL-3 in HIV-infected patients by describing the increase in WBC and plt counts and to assess its effect on viral load. Eligibility criteria included HIV+, ANC less than or equal to 2000/mm3, p24 antigen greater than or equal to 70 pg/ml, adequate renal and hepatic function, BM biopsy negative for infection, ECOG PS 0-2, no antiretroviral or cytokine therapy for greater than or equal to two weeks prior to study entry, and no active opportunistic infections. Nine pts have been entered on study: 3 women, 6 men, median age 33 (range 23-48), ECOG PS0 for 8 pts, PS2 for 1 pt, median ANC at entry 800 (range 288-1400), median CD4 count 24 cells/mm3 (range 0-180). All pts had received prior ZDV. Four pts were treated with rIL-3 1.0 ug/kg/day sc. 5 pts were treated with rIL-3 2.5 ug/kg/day sc. All 9 pts had hematologic efficacy (normalization or doubling of ANC) without significant toxicity or viral proliferation (defined as a 50% increase over baseline p24Ag level). Three pts had entry platelet counts less than or equal to 100,000/mm3. 3/3 pts had doubling or normalization of platelet count. Hematologic efficacy occurred at a median of 7 days from initiation of therapy (range 4-11). Four pts with HIV-related NHL received rIL-3 7.5 ug/kg/day sc, d2-19 + ZDV + CHOP chemotherapy. 4/4 pts required a delay in cycle 2 chemotherapy due to neutropenia. Conclusion: rIL-3 results in significant improvement in ANC and platelets for pts with HIV-related myelosuppression without toxicity or increases in viral proliferation. In combination with chemotherapy and ZDV however, rIL-3 at this dose, was not adequate to maintain WBC and platelet counts.
Keywords: Adult Combined Modality Therapy Comparative Study Dose-Response Relationship, Drug Female Human HIV Seropositivity/IMMUNOLOGY/*THERAPY Interleukin-3/*ADMINISTRATION & DOSAGE Leukocyte Count/DRUG EFFECTS Male Middle Age Neutropenia/IMMUNOLOGY/*THERAPY Recombinant Proteins/ADMINISTRATION & DOSAGE Zidovudine/*ADMINISTRATION & DOSAGE ABSTRACT CLINICAL TRIAL RANDOMIZED CONTROLLED TRIAL CLINICAL TRIAL, PHASE I 940830
M9480786
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Important note: Information in this article was accurate in 1994. The state of the art may have changed since the publication date.
