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NCT02788175 · ClinicalTrials.gov registry record · Phase 1
Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT02788175: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02788175 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02788175, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: In most people infected with human immunodeficiency virus (HIV), their immune system cannot control HIV infection. They need drugs called combination antiretroviral therapy (cART) to control the HIV. When people stop cART treatment, their immune system cannot control the infection again. They can also become resistant to cART and have lasting side effects. Researchers want to test if the drug vedolizumab is effective at controlling HIV infection without the need for cART. Objective: To test if vedolizumab is safe and can control the amount of HIV in the blood when cART is not taken. Eligibility: People ages 18-65 who have HIV and are being treated with cART Design: Participants will be screened with: Physical exam Medical history Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity. Blood and urine tests Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It will include repeats of the screening tests and: Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white blood cells from the blood. The rest of the blood is returned to the participant. Neurologic exam: The nerves and reflexes are tested. First vedolizumab infusion through an arm vein Participants will have visits every 4 weeks for 30 weeks. These will include: Vedolizumab infusions Repeats of baseline tests Participants will have more visits for blood draws. Participants will keep taking cART until after the week 22 infusion. After discontinuing cART at study week 22, participants will be seen every two weeks to monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in between infusion visits and will only take about 1 hour to complete. cART will be restarted if a participant's HIV levels go up to high, or if their CD4 cell counts decreases by too much. For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. T
Primary Outcome
The primary endpoint was the number of grade 2 or higher adverse events, including serious adverse events, that were probably or definitely related to vedolizumab.
Interventions
- BIOLOGICAL Entyvio (Vedolizumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2016-05-28 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 1 |
What the finished NCT02788175 record still lists
NCT02788175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Entyvio (Vedolizumab) is the first listed.
NCT02788175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02788175 about?
NCT02788175 is a clinical study titled "Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption". Background: In most people infected with human immunodeficiency virus (HIV), their immune system cannot control HIV infection. They need drugs called combination antiretroviral therapy (cART) to control the HIV. When people stop cART treatment, their immune system cannot control the infection again...
What is the current status of trial NCT02788175?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2016-05-28. Estimated completion is 2019-03-04.
What interventions are being tested in trial NCT02788175?
The interventions under investigation include: Entyvio (Vedolizumab) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02788175?
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 NCT02788175's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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