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
Condition: HIV Infections; Pregnancy
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      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.
    

Intervention name(s): CD4-IgG
Intervention type(s): Drug
Intervention MeSH terms: CD4 Immunoadhesins
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Recombinant Proteins; Pregnancy Trimester, Third; Pregnancy; Pregnancy Complications, Infectious; IgG; Drug Evaluation; Antigens, CD4; AIDS-Related Complex; Immunization, Passive