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OpenTrials
Completed

NCT Number: NCT00002009

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Cytopenia Cytopenias Genital Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Leukocyte Disorders Leukopenia RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

UCLA CARE Ctr, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sargramostim

Drug

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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