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NCT00005758 · ClinicalTrials.gov registry record · Phase 3
Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 472
- Enrollment target
NCT00005758: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00005758 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 472 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005758, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 472 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load (level of HIV in the blood) and on the way the immune system responds to HIV. This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below 50 copies/ml compared to those who have a viral load from 50 to 500 copies/ml. (This study is currently being redesigned and the purpose may be revised.) Treatment with anti-HIV drugs does not always keep HIV viral load undetectable (so low that it cannot be measured). This study originally added an HIV vaccine called Remune to treat patients. Remune was thought to reduce viral load and improve immune responses. However, new information suggests that Remune may not be as effective as was first believed. The study has been changed to follow people already in the study and to let people enroll only if they participate in the substudy. The substudy will look at the effect of another HIV vaccine, vCP1452, on the immune response and how it works in combination with Remune. Information about the safety of these vaccines in HIV-positive patients will be gathered.
Interventions
- BIOLOGICAL HIV-1 Immunogen
- BIOLOGICAL ALVAC(2)120(B,MN)GNP (vCP1452)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 472 participants |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
What the finished NCT00005758 record still lists
NCT00005758 is an interventional study that assigns participants to a tested intervention. The registered 472 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which HIV-1 Immunogen is the first listed.
NCT00005758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005758 about?
NCT00005758 is a clinical study titled "Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination". The purpose of this study is to look at the effects of the HIV vaccine Remune on viral load (level of HIV in the blood) and on the way the immune system responds to HIV. This study will also try to see if the effects of the vaccine are different in patients entering the study with a viral load below...
What is the current status of trial NCT00005758?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 472 participants. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00005758?
The interventions under investigation include: HIV-1 Immunogen (BIOLOGICAL), ALVAC(2)120(B,MN)GNP (vCP1452) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00005758?
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 NCT00005758's enrollment target sits among peer trials
472 811th of 2000 higher than 1,189 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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