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NCT00000642 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00000642 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants.
The verdict
NCT00000642, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG CD4-IgG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000642
The ClinicalTrials.gov registry entry for NCT00000642 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CD4-IgG is the first listed.
NCT00000642 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000642 about?
NCT00000642 is a clinical study titled "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 de...
What is the current status of trial NCT00000642?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants.
What interventions are being tested in trial NCT00000642?
The interventions under investigation include: CD4-IgG (DRUG).
Who is sponsoring clinical trial NCT00000642?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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