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NCT00000977 · ClinicalTrials.gov registry record · Phase 1
Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT00000977: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000977 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000977, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with \> 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose. To describe both cellular and humoral immune responses to HIV-1 in the immunized individuals. To describe the effects of this immunization on general immunological, virological and clinical parameters. To evaluate the safety of injecting recombinant gp160 in this population. To evaluate the extent of variability between different lots of gp160 (arms C1 and C2). It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit.
Interventions
- BIOLOGICAL gp160 Vaccine (MicroGeneSys)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Est. Completion | 1993-05 |
| Phase | Phase 1 |
What the finished NCT00000977 record still lists
NCT00000977 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which gp160 Vaccine (MicroGeneSys) is the first listed.
NCT00000977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000977 about?
NCT00000977 is a clinical study titled "Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity". To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with \> 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose. To describe both cellular and humoral immune responses to HIV-1 in the immunized ...
What is the current status of trial NCT00000977?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. Estimated completion is 1993-05.
What interventions are being tested in trial NCT00000977?
The interventions under investigation include: gp160 Vaccine (MicroGeneSys) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00000977?
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 NCT00000977's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 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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