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OpenTrials
Completed

NCT Number: NCT00002281

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

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.

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Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Cytopenia Cytopenias Genital Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Med Ctr

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filgrastim

Drug

Epoetin alfa

Drug

Zidovudine

Drug

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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