A Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HIVIG) and of Zidovudine (ZDV) in Infants With Documented HIV Infections

Inclusion Criteria

Concurrent Medication:

Allowed:

• Recommended:
• Standard immunizations. Should repeat MMR 3 months after discontinuing study.
• Benadryl and/or aspirin.
• Pneumocystis carinii pneumonia prophylaxis.
• Systemic ketoconazole and acyclovir, or oral nystatin for acute therapy.
• Aerosol ribavirin for short-term treatment of RSV.

Concurrent Treatment:

Allowed:

• Blood transfusion.

Patients must have the following:

• Parent or guardian available to give written informed consent.
• Protocol requires prior Institutional Review Board (IRB) approval before any subject is entered into study.

Prior Medication:

Allowed:

• Gammaglobulin, intravenous (IV) or intramuscular (IM).
• Immunoglobulin, IV (IVIG).
• Maternal antiretroviral treatment during pregnancy.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
• Presence of serious acute infection requiring parenteral treatment at time of study entry.

Concurrent Medication:

Excluded:

• Prophylaxis for oral candidiasis or otitis media or other infections.
• Immunoglobulin therapy (except single dose or for hypogammaglobulinemia).
• Ketoconazole, acyclovir, or nystatin for prophylaxis.

Patients with the following are excluded:

• Symptomatic of any class P-2 symptoms (except lymphadenopathy at time of study entry.
• Presence of serious acute infection requiring parenteral treatment at time of study entry.

Prior Medication:

Excluded:

• Antiretroviral treatment or experimental treatment within 2 weeks of entry.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety