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NCT01866826 · ClinicalTrials.gov registry record · Phase 1
Rifaximin for Chronic Immune Activation in People With HIV
A Phase 1 study of HIV, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 3
- Study locations
NCT01866826 is a Phase 1 study of HIV that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT01866826, a Phase 1 study of HIV, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 3
- Study locations
Study Summary
Background: * Human immunodeficiency virus (HIV) treatment can control the amount of virus in the blood, but it does not provide a cure. The reasons why HIV treatment does not cure the infection are not well understood. HIV persists in blood cells for years, even if people receive treatment for it. In addition, HIV infection leads to an activated immune system, which can cause other problems. * One theory for why HIV infection causes immune activation involves the intestinal tract. HIV infects immune cells the intestine soon after infection and damages their immune barrier. This damage lets bacteria cross into the bloodstream, leading to ongoing inflammation. Even when a person with HIV feels well, this chronic inflammation may affect the immune system. Researchers want to see if the antibiotic Rifaximin can reduce this inflammation. Rifaximin is designed to stay inside the digestive system, so it affects only bacteria in the intestines. Objectives: \- To see if Rifaximin can reduce bacteria-related inflammation in people with HIV. Eligibility: \- Individuals at least 18 years of age who have HIV infection and are taking medications to treat it. Design: * Participants will be screened with a physical exam, blood test, and medical history. * Participants will take either Rifaximin or a placebo for 4 weeks. They will have no medication for 4 to 6 weeks, and then take the other drug for 4 more weeks. * During the study, participants will have frequent blood and urine tests. They will also provide stool samples. Liver and kidney function tests will be performed. HIV viral load (the amount of virus in the blood) will also be studied. * Participants will have a final follow-up visit after an additional 4 weeks. * Two additional tests are optional for study participants: * Two blood draws: one on the third day after starting Rifaximin, and one on the third day after starting the placebo. * Up to three colonoscopies of the lower intestine and biopsies of the intestin
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Rifaximin
Study Locations (3)
Maryland
- Walter Reed National Medical Center - Bethesda
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2013-01-18 |
| Est. Completion | 2018-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01866826
The ClinicalTrials.gov registry entry for NCT01866826 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01866826 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01866826 about?
NCT01866826 is a clinical study titled "Rifaximin for Chronic Immune Activation in People With HIV". Background: * Human immunodeficiency virus (HIV) treatment can control the amount of virus in the blood, but it does not provide a cure. The reasons why HIV treatment does not cure the infection are not well understood. HIV persists in blood cells for years, even if people receive treatment for it....
What is the current status of trial NCT01866826?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2013-01-18. Estimated completion is 2018-02-28.
What conditions does trial NCT01866826 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT01866826?
The interventions under investigation include: Placebo (OTHER), Rifaximin (DRUG).
Who is sponsoring clinical trial NCT01866826?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01866826 being conducted?
This trial has 3 study locations across Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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