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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002006
• Other study ID #: 067A
• Secondary ID: 07936
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To assess the safety and efficacy of subcutaneously administered sargramostim ( granulocyte-macrophage colony-stimulating factor; GM-CSF ) in increasing and maintaining the neutrophil count in HIV-infected adults who have developed neutropenia as a result of receiving the antiretroviral agent, zidovudine ( AZT ). To assess the safety and efficacy of subcutaneously administered GM-CSF in increasing and maintaining the neutrophil count in HIV-infected adults with pre-existing neutropenia who are at high risk of developing hematologic intolerance while receiving the antiretroviral agent, AZT, for the first time. To assess the potential therapeutic benefit of concomitant GM-CSF and AZT on the natural history of HIV infection and associated infectious complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cytopenias
• HIV Infections
• Infection
• Leukopenia

Intervention

Drug:
• Zidovudine

• Sargramostim

Locations

Country	Name	City	State
United States	Natl Cancer Institute	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Levine JD, Allan JD, Tessitore JH, Falcone N, Galasso F, Israel RJ, Groopman JE. Recombinant human granulocyte-macrophage colony-stimulating factor ameliorates zidovudine-induced neutropenia in patients with acquired immunodeficiency syndrome (AIDS)/AIDS-related complex. Blood. 1991 Dec 15;78(12):3148-54. — View Citation