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

Launched by SANDOZ · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • 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
• 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.