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

An agent that can prevent HIV infection is desirable for those at risk of infection as well as in the pregnant female and newborn populations. Such an agent may help prevent the progression of the disease in infants and children in early stages of infections. In theory, rCD4-IgG has antiviral effects. Part 1: Per the original protocol, a total of six pregnant women were enrolled in Groups A and B. Patients in Group A received rCD4-IgG at the onset of labor, and those in Group B received rCD4-IgG twice per week, beginning 1 week before the expected date of delivery. Newborns were not treated in Part 1 of the study. AMENDED: In Part 2 of the study, a total of nine pregnant women are enrolled in Groups C, D, and E and receive a higher dose of rCD4-IgG at the onset of labor. If the mother has not delivered 18 hours after rCD4-IgG injection, a second injection at the same dose is administered; daily injections are given thereafter until delivery. The newborns receive 1 of 3 doses of rCD4-IgG daily for the first 5 days of life. Infants are enrolled sequentially to each dose level.