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A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility


Phase 1
18 Years
N/A
Not Enrolling
Both
HIV Infections, Cytopenias

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Trial Information

A Phase I/II Pilot Study of Simultaneously Administered Rhu GM-CSF ( CHO Cell ) and Azidothymidine ( AZT ) in Patients With Severe HIV Infection and Leukopenia: Pharmacokinetics and Feasibility

Inclusion Criteria


Inclusion Criteria

Concurrent Treatment:

Allowed:

- Minimal local irradiation for tumors.

Patients must have:

- Diagnosis of AIDS or AIDS related complex (ARC).

- Neutropenia, due either to zidovudine (AZT) or HIV infection.

- Life expectancy = or > 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Significant malabsorption as defined by greater than 10 percent weight loss and one
or more of the following:

- Serum carotene less than 75 IU/ml.

- Vitamin A level less than 75 IU/ml.

- More than 4 foul-smelling or greasy stools per day.

- Other criteria of malabsorption.

- Kaposi's sarcoma (KS) or other tumor which is likely to require specific antitumor
therapy during study, other than minimal local irradiation.

- Active, life-threatening infection with bacterial, viral, fungal, or protozoan
pathogens or fever of 39 degrees C within 10 days of study entry, unless it is
apparent that the fever is not due to a severe underlying infection.

Concurrent Medication:

Excluded within 4 weeks of study entry:

- Any investigational drug.

- Immunomodulating agents.

- Hormonal therapy.

- Cytolytic chemotherapeutic agents.

- Antiretroviral agent other than zidovudine (AZT).

- Excluded within 4 months of study entry:

- Suramin.

- Excluded within 3 months of study entry:

- Ribavirin.

Patients with the following are excluded:

- Significant malabsorption.

- Tumor likely to require specific antitumor therapy during study.

- Other significant medical problems and conditions specified in Patient Exclusion
Co-Existing Conditions.

- Uncorrected nutritional deficiencies that may contribute to neutropenia.

- Hypersensitivity to zidovudine (AZT) or other nucleoside analogs.

- Profound dementia or altered mental status that would prohibit the giving of informed
consent.

Prior Treatment:

Excluded within 1 month of study entry:

- Transfusion.

- Excluded within 4 weeks of study entry:

- Radiation therapy to greater than 100 cm2 body area.

Current drug or alcohol abuse. Unprotected sexual behavior or other activities which might
introduce a new inoculation of HIV during the study.

Patients must be willing to refrain from unprotected sexual or other activities which
might introduce a new inoculum of HIV during the study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

067A

NCT ID:

NCT00002006

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Cytopenias
  • Neutropenia
  • Drug Interactions
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Leukopenia

Name

Location

Natl Cancer InstituteBethesda, Maryland  20892