A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Sandoz

Status and phase: Completed; Phase 1

Conditions: Cytopenias; HIV Infections

Treatments: Drug: Sargramostim

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002009

067E

101

Details and patient eligibility

About

To determine the maximum tolerated dose (MTD) and toxicity of sargramostim (recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF) given by continuous intravenous infusion (CIV) in patients with leukopenia in association with AIDS virus infection. In addition, single dose and steady state pharmacokinetics will also be determined.

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients must have:

• Met the CDC criteria for the diagnosis of AIDS.
• Total peripheral blood leukocyte count = or < 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
• Must have or have recovered from one or more opportunistic infection.
• Serum antibody to HTLV-III/LAV with or without viremia.
• Anticipated survival of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• AIDS related complex (ARC).
• History of malignancy other than Kaposi's sarcoma (KS).
• Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
• Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infections.
• Presence of renal dysfunction.
• Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.

Patients with the following are excluded:

• AIDS related complex (ARC).
• History of malignancy other than Kaposi's sarcoma (KS).
• Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
• Currently hospitalized or hospitalized within the last 4 weeks for the treatment of an opportunistic infection.
• Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Prior Medication:

Excluded:

• Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
• Excluded within 6 weeks of study entry:
• Any investigational drug.

Prior Treatment:

Excluded within 6 weeks of study entry:

• Systemic cytotoxic chemotherapy or irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

• Regular, excessive use of alcohol, hallucinogens or agents which are addicting.