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 the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002255
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1991
  Purpose

To evaluate the safety, tolerance, and biological activity of filgrastim (recombinant granulocyte colony stimulating factor; G-CSF) given by daily subcutaneous injection prior to and concomitantly with erythropoietin (EPO) and zidovudine (AZT) in patients with AIDS or severe ARC. To evaluate the safety, tolerance, and biological activity of recombinant EPO given three times weekly by subcutaneous 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 three dose levels of AZT given concomitantly with G-CSF and EPO in patients with AIDS or severe ARC. To study the effects of G-CSF on neutrophil function and number in patients with AIDS or severe ARC. 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 Phase
HIV Infections
Drug: Filgrastim
Drug: Epoetin alfa
Drug: Zidovudine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
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 the Acquired Immune Deficiency Syndrome (AIDS) or Severe AIDS-Related Complex (ARC)

Resource links provided by NLM:


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

  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Ganciclovir (DHPG) for treatment of CMV infections.

Concurrent Treatment:

Allowed:

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

Patients must have:

AIDS or severe ARC.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Opportunistic infection requiring ongoing therapy with known bone marrow-suppressive agents. (Exception:
  • patients may take ganciclovir for treatment of CMV infections.)
  • Evidence of a primary hematologic or infectious disorder unrelated to infection with the HIV virus.
  • HIV-related dementia or altered mental status that would prohibit informed consent.
  • More than 50 cutaneous Kaposi's sarcoma lesions or progression of Kaposi's sarcoma during the previous 30 days.
  • Uncontrolled hypertension (defined as diastolic greater than 100 mm Hg).
  • Presence of iron deficiency anemia as defined by serum ferritin less than 30 ng or iron TIBC ration less than 15 percent.

Concurrent Medication:

Excluded:

  • Known bone marrow-suppressive agents such as trimethoprim / sulfamethoxazole or Fansidar for PCP prophylaxis.
  • Any other non-FDA approved agent that may have antiretroviral activity.
  • Hyperimmunization with polio virus, ribavirin, isoprinosine, dextran sulfate, fu zheng herbs, AL 721 or its congeners, imuthiol, interferons, chronic (> 10 days out of 30 days) use of Zovirax (acyclovir), and/or > 3 g/day oral vitamin C.

Patients with the following prior conditions are excluded:

  • History of malignancy other than Kaposi's sarcoma.
  • History of cardiovascular disease or seizures.

Prior Medication:

Excluded:

  • Systemic cytotoxic chemotherapy within the previous 4 weeks for Kaposi's sarcoma.
  • Investigational drugs within the previous 4 weeks.
  • Prior colony stimulating factor (CSF).
  • Any non-FDA approved drug within the previous 2 weeks.

Prior Treatment:

Excluded:

  • Radiotherapy within the previous 4 weeks for Kaposi's sarcoma. Regular excessive use, currently or within the previous 3 months, of alcohol or hallucinogens or other psychotropic agents that are possibly addictive.
  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: NCT00002255

Locations
United States, California
UCLA Med Ctr
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Amgen
Investigators
Study Chair: Miles SA
Study Chair: Slamon D
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002255     History of Changes
Other Study ID Numbers: 077A, G-CSF 8808
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:
Erythropoietin
Granulocyte Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
HIV Infections
Syndrome
Disease
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
Retroviridae Infections
RNA Virus 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

ClinicalTrials.gov processed this record on October 20, 2014