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NCT00000633 · ClinicalTrials.gov registry record · Phase 1
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT00000633: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000633 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 55 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000633, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and immunogenicity of two different schedules of gp160 administration. To examine the effects of gp160 and hepatitis B vaccine (Engerix-B) on various markers of viral load and on selected immune parameters. Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus. Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis B vaccination) that would be expected to induce a nonspecific immune response in HIV-infected persons.
Interventions
- BIOLOGICAL Hepatitis B Vaccine (Recombinant)
- BIOLOGICAL gp160 Vaccine (Immuno-AG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Est. Completion | 1998-10 |
| Phase | Phase 1 |
What the finished NCT00000633 record still lists
NCT00000633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Hepatitis B Vaccine (Recombinant) is the first listed.
NCT00000633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000633 about?
NCT00000633 is a clinical study titled "A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals". To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and immunogenicity of two different schedules of gp160 administration. To examine the effects of gp160 and hepatitis B vacci...
What is the current status of trial NCT00000633?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. Estimated completion is 1998-10.
What interventions are being tested in trial NCT00000633?
The interventions under investigation include: Hepatitis B Vaccine (Recombinant) (BIOLOGICAL), gp160 Vaccine (Immuno-AG) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000633?
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 NCT00000633's enrollment target sits among peer trials
55 918th of 2000 higher than 1,070 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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