search
Back to results

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

Primary Purpose

HIV Infections, Cytopenias

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sargramostim
Sponsored by
Sandoz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA CARE Ctr
  • Beth Israel Deaconess - West Campus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Sandoz
search

1. Study Identification

Unique Protocol Identification Number
NCT00002008
Brief Title
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Official Title
An Open Label Phase I Study of Subcutaneously Administered Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sandoz

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytopenias
Keywords
Leukopenia, Drug Evaluation, Granulocyte-Macrophage Colony-Stimulating Factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sargramostim

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Beth Israel Deaconess - West Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs