An Open Label Phase I Study of Subcutaneously Administered 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:
NCT00002008
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1989
  Purpose

To determine the safety, immunogenicity, biological activity, ad pharmacokinetics of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) human granulocyte-macrophage colony-stimulating factor ( GM-CSF ), given by subcutaneous ( SC ) injection to patients with leukopenia in association with HIV infection.


Condition Intervention Phase
HIV Infections
Cytopenias
Drug: Sargramostim
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase I Study of Subcutaneously Administered 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:

  • Serum antibody to HIV with or without evidence of HIV.
  • Antigenemia.
  • Anticipated survival of at least 6 months.
  • Allowed:
  • Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malignancy other than Kaposi's sarcoma.
  • 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 infection.
  • Primary hematologic or infectious disorders unrelated to AIDS virus infection.
  • Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Patients with the following are excluded:

  • History of malignancy other than Kaposi's sarcoma.
  • Currently hospitalized or hospitalized within 4 weeks for the treatment of opportunistic infection.

Prior Medication:

Excluded within 3 weeks of study entry:

  • Marrow suppressive medication.
  • Excluded within 4 weeks of study entry:
  • Any investigational drug.

Prior Treatment:

Excluded within 4 weeks of study entry:

  • Systemic cytotoxic chemotherapy.
  • Irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

  • Regular, excessive users 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: NCT00002008

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002008     History of Changes
Other Study ID Numbers: 067D, 106
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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Leukopenia
Virus Diseases
Hematologic Diseases
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Leukocyte Disorders
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 22, 2014