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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002009
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1988
  Purpose

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.


Condition Intervention Phase
HIV Infections
Cytopenias
Drug: Sargramostim
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002009

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
United States, Massachusetts
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Sandoz Inc.
  More Information

Publications:
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)

ClinicalTrials.gov Identifier: NCT00002009     History of Changes
Other Study ID Numbers: 067E, 101
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Leukopenia
Drug Evaluation
Granulocyte-Macrophage Colony-Stimulating Factor

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Virus Diseases
Leukopenia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014