A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Summary

To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.

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Publications

• Background Levine JD, Allan JD, Tessitore JH, Falcone N, Galasso F, Israel RJ, Groopman JE. Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome (AIDS)/AIDS-related complex. Blood. 1991 Dec 15;78(12):3148-54.

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