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NCT00080106 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
NCT00080106: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00080106 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 114 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00080106, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
Study Summary
HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive either an HIV vaccine or a placebo. Participants will then stop taking their anti-HIV medications and the study will compare the viral loads of participants who received the vaccine with the viral loads of participants who received the placebo. Primary study hypotheses: 1)The Week 12 and Week 16 post-ART interruption geometric mean HIV-1 RNA levels will be lower among participants who had received MRK Ad5 vaccine prior to ART interruption than among participants who received placebo; 2) the time averaged area under the curve of the log10 HIV-1 RNA copies/ml versus day function in the 16 week post-ART interruption step will be lower among participants who received the MRK Ad5 vaccine prior to ART interruption than among participants who receive placebo.
Interventions
- BIOLOGICAL MRK Ad5 HIV-1 gag vaccine
- OTHER Vaccine placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2004-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00080106 record still lists
NCT00080106 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% lower).
The record links to 0 conditions, and to 2 interventions - of which MRK Ad5 HIV-1 gag vaccine is the first listed.
NCT00080106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00080106 about?
NCT00080106 is a clinical study titled "Effectiveness of and Immune Response to HIV Vaccination Followed by Treatment Interruption in HIV Infected Patients". HIV vaccines may help the immune systems of HIV infected patients better control the virus. The goal of this study is to determine whether patients on anti-HIV medications can stop taking those medications if they receive an HIV vaccine. While taking anti-HIV medications, participants will receive e...
What is the current status of trial NCT00080106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2004-06. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00080106?
The interventions under investigation include: MRK Ad5 HIV-1 gag vaccine (BIOLOGICAL), Vaccine placebo (OTHER).
Who is sponsoring clinical trial NCT00080106?
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 NCT00080106's enrollment target sits among peer trials
114 627th of 2000 higher than 1,370 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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