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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002009
• Other study ID #: 067E
• Secondary ID: 101
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1988
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytopenias
• HIV Infections
• Infection
• Leukopenia
• Virus Diseases

Intervention

Drug:
• Sargramostim

Locations

Country	Name	City	State
United States	Beth Israel Deaconess - West Campus	Boston	Massachusetts
United States	UCLA CARE Ctr	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barbarini G, Garavelli G, Grisorio B, Barbaro G, Giangregorio F. GM-CSF in HIV related leukopenia: efficacy and tolerability of three months therapy on 50 patients. Int Conf AIDS. 1996 Jul 7-12;11(1):313 (abstract no TuB2279)