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

Summary

Part 1: To determine both the safety, tolerance, and pharmacokinetic profile (blood levels) of recombinant CD4 immunoglobulin G (rCD4-IgG) by intravenous bolus administration (given through the vein) in women with HIV infection who are in their third trimester (last three months of pregnancy). To determine the safety of maternal/fetal transfer of rCD4-IgG in infants born to mothers entered into the study. To obtain a preliminary indication of the antiviral and immunologic effects of rCD4-IgG in HIV seropositive pregnant women and their newborns. AMENDED: Part 2: To determine the safety profile of rCD4-IgG in HIV-1-infected women at the onset of labor and in their newborns. To determine the extent of placental transfer of rCD4-IgG when administered to the mother at onset of labor. To determine the pharmacokinetics of rCD4-IgG in newborns. To obtain preliminary evidence of the ability of rCD4-IgG to prevent intrapartum transmission of HIV-1 from mother to fetus. 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.

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Publications

• Background Duliege AM, Shearer WT, Hammill H, Kline MW, Minkoff HL, Izu A, Ammann A. Transplacental transfer of rCD4-IgG given one week and immediately prior to birth: safety and pharmacokinetics in HIV-1 seropositive pregnant women and their newborn infants. Int Conf AIDS. 1992 Jul 19-24;8(2):B91 (abstract no PoB 3028)
• Background Shearer WT, Duliege AM, Kline MW, Hammill H, Minkoff H, Ammann AJ, Chen S, Izu A, Mordenti J. Transport of recombinant human CD4-immunoglobulin G across the human placenta: pharmacokinetics and safety in six mother-infant pairs in AIDS clinical trial group protocol 146. Clin Diagn Lab Immunol. 1995 May;2(3):281-5. doi: 10.1128/cdli.2.3.281-285.1995.

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