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.
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
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.
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Information provided by:
NIH AIDS Clinical Trials Information Service
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.
Drug: Epoetin alfa
||Masking: None (Open Label)
Primary Purpose: Treatment
||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
Information from the National Library of Medicine
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|Ages Eligible for Study:
||18 Years to 65 Years (Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
- Trimethoprim / sulfamethoxazole.
- Non-FDA approved antiretrovirals.
- Hyperimmunization with polio virus.
- Dextran sulfate.
- Fu zheng herbs.
- AL 721 or its congeners.
- 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.
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.
- Colony stimulating factors.
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.
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 ClinicalTrials.gov identifier (NCT number): NCT00002281
|UCLA Med Ctr
|Los Angeles, California, United States, 90095 |
History of Changes
|Other Study ID Numbers:
||November 2, 1999
||August 31, 2001
|Last Update Posted:
||June 24, 2005
Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs