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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005758
The ClinicalTrials.gov registry entry for NCT00005758 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 472 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 HIV-1 Immunogen is the first listed.
NCT00005758 reports 0 study locations.
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.
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