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

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002009 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
  • HIV Infections
  • Cytopenias
Drug: Sargramostim
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002009
067E, 101
Not Provided
Not Provided
Sandoz Inc.
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
June 1988

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP