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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

For Condition: HIV Infections,Cytopenias
Status: Completed
Sponsor(s): Sandoz Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Male
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Beth Israel Deaconess - West Campus
Boston,  Massachusetts,  02215
United States
 

UCLA CARE Ctr
Los Angeles,  California,  90095
United States
 


Additional Information:
Study ID Numbers:
  067E;  101
Study Start Date: 
Record last reviewed: June 1988
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002009

Other Hiv Infections Studies:
1. Granulocyte-Macrophage Colony-Stimulating Factor and Zidovudine: A Phase I Study of Concurrent Administration in Patients With AIDS and Severe ARC

2. An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients with AIDS Virus Infection and Leukopenia

3. A Phase I/II Pilot Study of Simultaneously Administered rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

4. Treatment Program for Anemia in AIDS Patients

5. A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS Patients With Anemia Induced by Their Disease and AZT Therapy

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

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