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NCT00000774 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 156
- Enrollment target
NCT00000774 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 156 participants.
The verdict
NCT00000774, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 156 participants
- Enrollment target
Study Summary
PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected women. To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants. SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women. Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression.
Interventions
- BIOLOGICAL rgp120/HIV-1MN
- BIOLOGICAL rgp120/HIV-1 SF-2
- BIOLOGICAL Placebo version of rgp120/HIV-1MN
- BIOLOGICAL Placebo version of rgp120/HIV-1SF2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Est. Completion | 1999-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000774
The ClinicalTrials.gov registry entry for NCT00000774 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 156 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 4 interventions - of which rgp120/HIV-1MN is the first listed.
NCT00000774 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000774 about?
NCT00000774 is a clinical study titled "A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers". PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected women. To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in a...
What is the current status of trial NCT00000774?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 156 participants. Estimated completion is 1999-01.
What interventions are being tested in trial NCT00000774?
The interventions under investigation include: rgp120/HIV-1MN (BIOLOGICAL), rgp120/HIV-1 SF-2 (BIOLOGICAL), Placebo version of rgp120/HIV-1MN (BIOLOGICAL), Placebo version of rgp120/HIV-1SF2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000774?
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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