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

Sponsor

Sandoz (Industry)

Overall Status

Completed

CT.gov ID

NCT00002006

Collaborator

(none)

Location

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Cytopenias	Drug: Zidovudine Drug: Sargramostim	Phase 1

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Treatment:

Allowed:

Minimal local irradiation for tumors.

Patients must have:

Diagnosis of AIDS or AIDS related complex (ARC).
Neutropenia, due either to zidovudine (AZT) or HIV infection.
Life expectancy = or > 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Significant malabsorption as defined by greater than 10 percent weight loss and one or more of the following:
Serum carotene less than 75 IU/ml.
Vitamin A level less than 75 IU/ml.
More than 4 foul-smelling or greasy stools per day.
Other criteria of malabsorption.
Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor therapy during study, other than minimal local irradiation.
Active, life-threatening infection with bacterial, viral, fungal, or protozoan pathogens or fever of 39 degrees C within 10 days of study entry, unless it is apparent that the fever is not due to a severe underlying infection.

Concurrent Medication:

Excluded within 4 weeks of study entry:

Any investigational drug.
Immunomodulating agents.
Hormonal therapy.
Cytolytic chemotherapeutic agents.
Antiretroviral agent other than zidovudine (AZT).
Excluded within 4 months of study entry:
Suramin.
Excluded within 3 months of study entry:
Ribavirin.

Patients with the following are excluded:

Significant malabsorption.
Tumor likely to require specific antitumor therapy during study.
Other significant medical problems and conditions specified in Patient Exclusion Co-Existing Conditions.
Uncorrected nutritional deficiencies that may contribute to neutropenia.
Hypersensitivity to zidovudine (AZT) or other nucleoside analogs.
Profound dementia or altered mental status that would prohibit the giving of informed consent.