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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (160% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00000774 record still lists
NCT00000774 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (160% higher).
The record links to 0 conditions, and to 4 interventions - of which rgp120/HIV-1MN is the first listed.
NCT00000774 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000774's enrollment target sits among peer trials
156 351st of 2000 higher than 1,649 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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