A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection

Inclusion Criteria Patients must have: HIV infection. CD4 count >= 2000 cells/mm3 AND >= 30 percent of total lymphocytes. No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted). Consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Serious acute infection requiring parenteral therapy at time of entry. One or more serious, proven bacterial infections including any of the following: septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria. Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile. Concurrent Medication: Excluded: Any agent with known antiretroviral activity. Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously. Prior Medication: Excluded: More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally. Recommended: PCP prophylaxis. Immunizations according to current recommendations.