Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of HIV, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
One sample Wilcoxon statistic was applied to evaluate the difference on treatment phases between the placebo and Rifaximin.
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 |
What the finished NCT01866826 record still lists
NCT01866826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01866826's enrollment target sits among peer trials
46 233rd of 303 higher than 70 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV 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
-
Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health
RECRUITING · Phase 1
-
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
RECRUITING · Phase 1
-
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
RECRUITING · Phase 1
-
HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 2 (2nd HARP Pilot Intervention)
RECRUITING · Phase 1
-
A Trial to Evaluate an HIV Envelope Trimer, N332-GT5 gp140, Adjuvanted With SMNP in Adult Participants Without HIV
ACTIVE NOT RECRUITING · Phase 1
-
Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01890590 · 46 participants · NA
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
- NCT03191149 · 46 participants · Phase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
- NCT03510208 · 46 participants · Phase 1
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
- NCT04048278 · 46 participants · Early Phase 1
Lidocaine Infusion in Pancreatic Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI