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

Completed · Not applicable

Conditions studied: HIV Infections, Cytopenias

In brief

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.

Key facts

Study ID

NCT00002007

Run by

Sandoz

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Natl Cancer Institute — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.