A Phase One Study of AS-101 in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)

Inclusion Criteria Concurrent Medication: Allowed: Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. Ketoconazole. Standard outpatient therapy for infections developing during the trial. Oral acyclovir for up to 7 days. Patients must have: Antibody to HIV by ELISA. AIDS or AIDS related complex (ARC). T4 cell count < 400 cells/mm3 on 2 determinations at least 72 hours apart. Prior Medication: Allowed: Inhaled pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis. Ketoconazole. Oral acyclovir for up to 7 days. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Active opportunistic infection or malignancy requiring concurrent treatment. Serious medical problems, such as diabetes, renal disease, ASHD, or hypertension, which would complicate interpretation of treatment results. Transfusion requirements exceeding 2 transfusions per month in order to achieve hemoglobin > 9 g/dl. Concurrent Medication: Excluded: Treatment for active opportunistic infection or malignancy. Systemic antiviral preparations. Immunosuppressive agents. Immunostimulation therapy. Specific therapy for Kaposi's sarcoma or other malignancies. Concurrent Treatment: Excluded: More than 2 units of red blood cell transfusions per month in order to achieve hemoglobin > 8 g/dl. Patients unlikely or unable, for reasons such as distance from the hospital or psychological considerations, to comply with the requirements of the protocol, especially in regard to regular attendance for treatment, are excluded. Prior Medication: Excluded: Systemic antiviral preparations. Isoprinosine. Excluded with 1 month of study entry: Immunosuppressive agents. Immunomodulators. Prior Treatment: Excluded: Immunostimulation therapy, such as BCG vaccine. Active drug or alcohol abuse.