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CompletedNCT00002007Updated Jun 24, 2005

A Pilot Trial Evaluating an Alternating Schedule of Recombinant Human GM-CSF and Azidothymidine in Patients With HIV Infection and Leukopenia

An interventional study of Zidovudine and Sargramostim in HIV Infections and Cytopenias, sponsored by Sandoz. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Sandoz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety of repeated courses of sargramostim ( recombinant granulocyte-macrophage colony-stimulating factor; GM-CSF ) administered subcutaneously to patients with HIV infection and leukopenia. To determine if administration of GM-CSF will prevent some or all of the hematologic toxicity associated with zidovudine ( AZT ) treatment in patients with pre-existing leukopenia. To assess any clinical and/or virologic benefits from administering alternating weeks of GM-CSF and AZT to patients with symptomatic HIV infection who have a history of cytologically confirmed Pneumocystis carinii pneumonia ( PCP ) or a circulating absolute CD4 lymphocyte count less than 200 cells/mm3.

02

Conditions studied

  • HIV Infections
  • Cytopenias

Keywords

  • Leukopenia
  • Granulocyte-Macrophage Colony-Stimulating Factor
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

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Lead sponsor

Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • Serum antibody to HIV with or without evidence of HIV antigenemia.
  • White blood cells (WBC) = or \< 4500 cells/mm3 measured on at least 2 occasions separated by a minimum of 1 week.
  • Qualifying indications for AZT therapy.
  • Life expectancy = or > 6 months.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Current or past history of malignancy including Kaposi's sarcoma.
  • Excessive diarrhea or significant malabsorption.
  • If patients have had > 10 percent weight loss within the past 3 months, they should not have malabsorption as evidenced by serum carotene \< 75 IU/ml, serum vitamin A \< 75 IU/ml, significant malabsorption 4 foul-smelling or greasy stools per day or other criteria.
  • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (IO).
  • Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
  • Active OI requiring systemic treatment.
  • Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Concurrent Medication:

Excluded within 4 weeks of study entry:

  • Zidovudine (AZT).
  • Other antiviral agent associated with leukopenia.
  • Investigational drug.
  • Immunomodulators.
  • Interferon.
  • Steroids.
  • Excluded within 8 weeks of study entry:
  • Ribavirin.
  • Excluded within 4 months of study entry:
  • Suramin.

Patients with the following are excluded:

  • Current or past history of malignancy including Kaposi's sarcoma.
  • Excessive diarrhea or significant malabsorption.
  • Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infection (OI).
  • Less than 1 week since completing treatment of Pneumocystis carinii pneumonia (PCP).
  • Evidence of nutritional deficiencies that may contribute to anemia and/or leukopenia.

Prior Medication:

Excluded:

  • Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) that may cause leukopenia.

Risk Behavior:

Excluded:

  • Current drug or alcohol abusers.
  • Unprotected sexual contact or other activities that may result in reinfection with HIV.

Patients must be willing to refrain from unprotected sexual contact or other activities that may result in reinfection with HIV.

05

Study design

Phase
Not applicable
Primary purpose
Treatment

Interventions

  • DrugZidovudine
  • DrugSargramostim
06

Study locations

1 site
  • Natl Cancer Institute
    Bethesda, Maryland 20892, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002007
Lead sponsor
Sandoz
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 1990. You cannot join it, but the record below documents what was studied.

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