Clinical trial NCT00002255: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Erythropoietin
Granulocyte Colony-Stimulating Factor
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Med Ctr
state: California
Study officials:
name: Miles SA
role: STUDY_CHAIR
name: Slamon D
role: STUDY_CHAIR
References:
citation: Miles SA, Mitsuyasu RT, Moreno J, Baldwin G, Alton NK, Souza L, Glaspy JA. Combined therapy with recombinant granulocyte colony-stimulating factor and erythropoietin decreases hematologic toxicity from zidovudine. Blood. 1991 May 15;77(10):2109-17.