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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Sargramostim

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.