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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002281
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1990
  Purpose

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 Intervention
HIV Infections
Cytopenias
Drug: Filgrastim
Drug: Epoetin alfa
Drug: Zidovudine

Study Type: Interventional
Study Design: Masking: 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 NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 24
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Treatment:

Allowed:

  • 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:

Excluded:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002281

Locations
United States, California
UCLA Med Ctr
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Amgen
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002281     History of Changes
Other Study ID Numbers: 061A, GCSF-8808-109
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014