A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 Immunoglobulin G (rCD4-IgG) in HIV-1 Seropositive Women During the Last Trimester of Pregnancy and Their Newborns

Inclusion Criteria Concurrent Medication: Allowed: * Iron, multivitamins, short courses of treatment for correctable medical problems (e.g., urinary tract infection), oral trimethoprim/sulfamethoxazole (TMP/SMX) or aerosolized pentamidine for prophylaxis of Pneumocystis carinii pneumonia (PCP), prophylactic antifungal therapy, or isoniazid (INH) therapy. * Acetaminophen. * Other supportive therapy (blood and blood products, vaginal creams, antiemetics, antidiarrheals, cough medicines). * Specific agents used during delivery, such as oxytocic agents or anesthetics. Participation in this protocol will not prevent a newborn from receiving any medication. Concurrent Treatment: Allowed: * Blood and blood product transfusions. * Gamma globulin as prophylaxis against infection with varicella virus and hepatitis virus, or RhoGAM in case of maternal-fetal incompatibility. Risk Behavior: Allowed: * Illicit drug use. Patients must be: * In their third trimester of pregnancy, or join the study with their newborn children. * Willing and able to sign informed consent. * Available for follow-up for at least 3 months. * The child should be available for follow-up for at least 1 year after delivery, and preferably longer. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: * Medical complications including, but not limited to, insulin dependent diabetes mellitus (IDDM), hypertensive disorders such as severe pre-eclampsia, eclampsia, chronic hypertension, cardiovascular disease including rheumatic or congenital heart disease, collagen vascular disease, endocarditis, and renal disease. * Hematological conditions including, but not limited to, hemoglobinopathies, coagulopathy, idiopathic thrombocytopenic purpura (ITP), and maternal-fetal blood incompatibilities with isoimmunization (e.g., Rh-negative mother with a positive indirect Coomb's test at any time during this pregnancy). * Neurological disease(s) including seizure disorders. * Bronchopulmonary diseases, such as severe asthma. * Evidence of fetal intolerance of the intrauterine environment. Concurrent Medication: Excluded: * Antiretroviral agents: * Suramin, ribavirin, HPA23, phosphonoformate, ansamycin, zidovudine (AZT), didanosine (ddI), or dideoxycytidine (ddC). * Other antiviral drugs, including acyclovir or ganciclovir. * Immunomodulating agents: * Interleukin 2, interferons, thymic hormones, or other agents. * Cytolytic chemotherapeutic agents. * Corticosteroids. * Immunoglobulin preparations. Concurrent Treatment: Excluded: * Radiation therapy. * Regular administration of gamma globulin. Patients with the following are excluded: * Serious medical or surgical complication of the pregnancy and/or delivery that required treatment during delivery or that might compromise the health of the mother or fetus. Any HIV-related complications requiring antiretroviral therapy during the pregnancy, including encephalopathy and opportunistic infections. * Systemic infection requiring IV therapy in the month prior to enrollment in this study (IV treatment for pyelonephritis is permitted). Prior Medication: Excluded: * Recombinant CD4 immunoglobulin G (rCD4-IgG). Excluded within 4 weeks of study entry: * Antiretroviral agents: * Suramin, ribavirin, HPA23, phosphonoformate, ansamycin, zidovudine (AZT), didanosine (ddI), or dideoxycytidine (ddC). * Other antiviral drugs, including acyclovir or ganciclovir. * Immunomodulating agents: * Interleukin 2, interferons, thymic hormones, or other agents. * Cytolytic chemotherapeutic agents. * Corticosteroids. * Immunoglobulin preparations. Prior Treatment: Excluded within 4 weeks of study entry: * Radiation therapy. History of poor medical compliance (at the discretion of the investigator). Current illicit drug use.