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NCT01859325 · ClinicalTrials.gov registry record · Phase 1
Therapeutic Vaccine for HIV
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01859325: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01859325 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01859325, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
Background: \- In most people who have human immunodeficiency virus (HIV), the immune system cannot control or cure the infection. Antiretroviral therapy drugs can keep the amount of HIV virus low for a long time. However, this treatment does not remove the virus from the body. In the vast majority of patients antiretroviral therapy also will not protect the body from the virus once treatment stops. Researchers want to see if therapeutic vaccination can help people with HIV. Therapeutic vaccination means giving vaccines to treat an infection that someone already has (HIV, in this case). It may help the body's immune system attack the infection. This study will look at different measures of HIV infection after receiving either therapeutic vaccination or a placebo. Objectives: \- To see whether therapeutic vaccination is safe and can affect how the body responds to HIV infection. Eligibility: \- Individuals between 18 and 65 years of age who have HIV and are taking antiretroviral therapy drugs. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * During the screening visit and throughout the study until week 56, participants will continue to take their HIV medications. * Participants will be divided into two groups. One group will have the study vaccines. The other will have a placebo. * The first study vaccine or placebo will be given in weeks 4, 12, and 36. The second study vaccine or the placebo will be given in weeks 24 and 48. Blood samples and other tests will be given at each visit. * After the study visit at week 56, participants will stop their HIV medications until week 72. From weeks 58 through 72, they will come in every 2 weeks for study visits; each visit will take about 1 hour to complete. These visits will look at the body s response to the vaccines and their HIV viral load. After week 72, participants will re-start their HIV medications. * There will be follow-up study vi
Primary Outcome
The rate of occurrence of grade 3 or higher AEs, including serious adverse events (SAEs) that per standard criteria (see safety section) are: At least possibly related to the test article, and Definitely NOT related to a factor other than the test article This is to evaluate safety and tolerability of the study vaccines.
Interventions
- DRUG Placebo
- BIOLOGICAL rVSV
- BIOLOGICAL IL-12 pDNA adjuvant
- BIOLOGICAL HIV-Mag pDNA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-05-10 |
| Est. Completion | 2017-02-26 |
| Phase | Phase 1 |
What the finished NCT01859325 record still lists
NCT01859325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01859325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01859325 about?
NCT01859325 is a clinical study titled "Therapeutic Vaccine for HIV". Background: \- In most people who have human immunodeficiency virus (HIV), the immune system cannot control or cure the infection. Antiretroviral therapy drugs can keep the amount of HIV virus low for a long time. However, this treatment does not remove the virus from the body. In the vast majority...
What is the current status of trial NCT01859325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-05-10. Estimated completion is 2017-02-26.
What interventions are being tested in trial NCT01859325?
The interventions under investigation include: Placebo (DRUG), rVSV (BIOLOGICAL), IL-12 pDNA adjuvant (BIOLOGICAL), HIV-Mag pDNA (BIOLOGICAL).
Who is sponsoring clinical trial NCT01859325?
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 NCT01859325's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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