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

• Patients must have a positive antibody to HIV confirmed by a federally licensed ELISA test kit.
• The CD4 cell count must be 201 - 799 cells/mm3 measured on two separate occasions within 60 days at least 72 hours apart prior to study entry (at least 1 of 2 counts and the mean must be \< 800 cells/mm3, and at least 1 of 2 counts and the mean must be > 200 cells/mm3). The last count must be within 14 days of study entry.

Concurrent Medication:

Allowed:

• Acetaminophen and acetaminophen products but use should be minimized. Continuous use for > 72 hours is discouraged.
• Aerosolized pentamidine.

Prior Medication:

Allowed:

• Chemoprophylaxis for Pneumocystis carinii pneumonia with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer if patient has CD4(+) count \< 200 cells/mm3 measured on 2 determinations at least 48 hours apart.

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.