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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000633
The ClinicalTrials.gov registry entry for NCT00000633 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 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 2 interventions - of which Hepatitis B Vaccine (Recombinant) is the first listed.
NCT00000633 reports 0 study locations.
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.
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