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



An Open Label Phase I Study of Subcutaneously Administered 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 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Male
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

UCLA CARE Ctr
Los Angeles,  California,  90095
United States
 

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


Additional Information:
Study ID Numbers:  067D;  106
Study Start Date: 
Record last reviewed: January 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002008

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2. 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

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

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

5. 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

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