HIV Infections Clinical Trial
Official title:
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
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Prevention
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