The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients

Exclusion Criteria

• •Co-existing Condition:
• •Patients with any of the following symptoms or conditions are excluded:
• •CMV, MAC, toxoplasmosis, or disseminated fungal infection requiring acute or chronic therapy.
• •Significant medical illness as determined by investigator.
• •Active diagnosis of any malignancy, including visceral Kaposi's sarcoma or extensive cutaneous Kaposi's sarcoma for which systemic chemotherapy is anticipated within the next 24 weeks.
• •Current Grade 2 or greater peripheral neuropathy.
• •Concurrent Medication:
• •Excluded:
• •Acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection.
• •AS PER AMENDMENT 5/5/97:
• •All antiretroviral medications other than those provided on study.
• •Systemic chemotherapy for active malignancies, including systemic treatment for KS.
• •Agents with myelosuppressive potential, including tegretol, carboplatin, carmustine, cyclophosphamide and fluorouracil.
• •Granulocyte colony stimulating factor (G-CSF) except while hydroxyurea or matching placebo is held.
• •Drugs associated with peripheral neuropathy, including:
• •hydralazine, disulfiram, nitrofurantoin, cisplatinum, diethyldithiocarbamate, gold, rifampin, chloramphenicol, clioquinol, ethambutol, ethionamide, glutethimide, sodium cyanate, and thalidomide.
• •Patients with any of the prior conditions are excluded:
• •History of transfusion dependent anemia, defined as any history of repeated transfusion with two or more units of red blood cells.
• •At the discretion of the investigator, history of pancreatitis.
• •Prior Medication:
• •Excluded:
• •More than 2 weeks prior treatment with ddI.
• •AS PER AMENDMENT 5/5/97:
• •Other antiretrovirals must be discontinued at least 14 days prior to randomization.
• •Prior hydroxyurea.
• •Any candidate HIV vaccine or agent with potential immune modulating effects within the past 30 days.
• •Any colony stimulating factor or erythropoietin within the past 60 days.
• •Prior Treatment:
• •Excluded:
• •Transfusion with red blood cells within the past 60 days.
• •Risk Behavior:
• •Excluded:
• •At the investigator's discretion, any active substance abuse, including alcohol abuse interfering with compliance.