The Safety and Effectiveness of Zidovudine in the Treatment of Patients With Early AIDS Related Complex

Exclusion Criteria

• •Concurrent Medication:
• •Excluded:
• •Other antiretroviral agents, biologic modifiers or corticosteroids.
• •Other experimental medications.
• •Systemic chemoprophylaxis of Pneumocystic carinii pneumonia (PCP) - aerosolized pentamidine is allowed.
• •Prior Medication:
• •Excluded:
• •Zidovudine (AZT).
• •Other antiretroviral agents.
• •Excluded within 30 days of study entry:
• •Biologic modifiers or corticosteroids.
• •Excluded within 60 days of study entry:
• •Ribavirin.
• •Prior Treatment:
• •Excluded within 30 days of study entry:
• •Blood transfusions.
• •Patients may not have any of the following diseases or symptoms:
• •Active oral candidiasis at entry.
• •An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
• •Temperature \> 38.5 degrees C persisting for \> 14 consecutive days or \> 15 days in a 30-day interval present at entry.
• •Chronic diarrhea defined as = or \> 3 liquid stools per day, persisting for \> 14 days without a definable cause during the past 2 years.
• •HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
• •Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• •Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.
• •Patients may not have any of the following diseases or symptoms:
• •Active oral candidiasis at entry.
• •An opportunistic infection or malignancy fulfilling the definition of AIDS (CDC Surveillance Case Definition for Acquired Immunodeficiency Syndrome).
• •Temperature \> 38.5 degrees C persisting for \> 14 consecutive days or \> 15 days in a 30-day interval present at entry.
• •Chronic diarrhea defined as = or \> 3 liquid stools per day, persisting for \> 14 days without a definable cause during the past 2 years.
• •HIV neurologic disease as manifested by motor abnormalities including impaired rapid eye movements or ataxia; motor weakness in the lower extremities; sensory deficit consistent with a peripheral neuropathy; bladder or bowel incontinence.
• •Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• •Subjects with hemophilia should be evaluated and treated under the hemophilia protocols, if available at that ACTG.
• •Active drug or alcohol abuse.