A Study of Granulocyte Colony-Stimulating Factor Plus Recombinant Erythropoietin Plus Zidovudine in Patients With AIDS or AIDS-Related Complex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002281
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
To evaluate the safety, tolerance and biological activity of filgrastim (granulocyte colony-stimulating factor; G-CSF) given by daily subcutaneous (SC) injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe AIDS related complex (ARC). To evaluate the safety, tolerance, and biological activity of EPO given 3 times weekly by SC injection concomitantly with G-CSF and prior to and concomitantly with AZT in patients with AIDS or severe ARC. To study the safety and tolerance of 3 dose levels of AZT given to patients with AIDS or severe ARC concomitantly treated with G-CSF and EPO. To study the effect of G-CSF alone and in combination with EPO on HIV replication in vivo as measured by circulating HIV p24 antigen, plasma HIV viremia and semiquantitative HIV cocultures.

Condition or disease Intervention/treatment Phase
HIV Infections Cytopenias Drug: Filgrastim Drug: Epoetin alfa Drug: Zidovudine Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase I/II Study of Recombinant Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) and Recombinant Erythropoietin (rHuEPO) Given Subcutaneously Along With Zidovudine (AZT) to Patients With AIDS or ARC

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Treatment:


  • Radiation or laser therapy to Kaposi's sarcoma lesions provided the dose does not exceed 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.

Patients must have:

  • A diagnosis of AIDS or AIDS related complex (ARC) as defined by current CDC guidelines.
  • Life expectancy > 6 months.
  • Defined blood cell counts that may be achieved by transfusion.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • History of malignancy other than Kaposi's sarcoma (KS).
  • Presence of > 50 cutaneous KS lesions or progression of KS over the previous 30 days.
  • Presence of opportunistic infection requiring ongoing therapy with known bone marrow suppressive agents.
  • History of cardiovascular disease.
  • History of seizures.
  • HIV related dementia or altered mental status that would prohibit the giving and understanding of informed consent.
  • Presence of iron deficiency anemia as defined by serum ferritin < 30 ng or iron to TIBC ratio < 15 percent.
  • A PT > 15 and a PTT > 40 unless due to a documented circulating lupus anticoagulant.

Concurrent Medication:


  • Trimethoprim / sulfamethoxazole.
  • Fansidar.
  • Non-FDA approved antiretrovirals.
  • Hyperimmunization with polio virus.
  • Ribavirin.
  • Isoprinosine.
  • Dextran sulfate.
  • Fu zheng herbs.
  • AL 721 or its congeners.
  • Imuthiol.
  • Interferons.
  • Chronic use of acyclovir (> 10 days out of 30 days).
  • = or > 3g/day oral vitamin C.

Patients with the following are excluded:

  • Co-existing conditions and symptoms described in Patient Exclusion Co-existing Conditions.

Prior Medication:

Excluded within 2 weeks of study entry:

  • Any non-FDA approved drug.
  • Excluded within 4 weeks of study entry:
  • Systemic cytotoxic chemotherapy for Kaposi's sarcoma.
  • Investigational agents.
  • Excluded:
  • Colony stimulating factors.

Prior Treatment:

Excluded within 4 weeks of study entry:

  • Radiation therapy for Kaposi's sarcoma exceeding 3000 rads to any one lesion group and/or greater than 10 cm2 total body surface area.

Risk Behavior:

Excluded within 3 months of study entry:

  • Regular excessive use of alcohol, hallucinogens or other psychotropic agents which are possibly addicting.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002281

United States, California
UCLA Med Ctr
Los Angeles, California, United States, 90095
Sponsors and Collaborators

Publications: Identifier: NCT00002281     History of Changes
Other Study ID Numbers: 061A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1990

Keywords provided by NIH AIDS Clinical Trials Information Service:
Injections, Subcutaneous
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
AIDS-Related Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Epoetin Alfa
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs