At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Documented HIV infection
- ✓Virologically suppressed on ART for ≥3 years with all VL <50 c/mL (except up to one blip <200 c/mL per 12-month period)
- ✓Current VL <50 c/mL at screening
- ✕Known bleeding diathesis (e.g., hemophilia, Von Willebrand disease)
- ✕Active drug use or alcohol abuse/dependence interfering with study participation
- ✕Serious illness requiring hospitalization within 30 days of screening
- ✕Active opportunistic infections or neoplasms (excluding cutaneous basal/squamous cell carcinoma) in 6 months prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double Blind Randomized Placebo Controlled Study Examining the Effects of a Non-Absorbable (Rifaximin) Antibiotic on the Chronic Immune Activation Observed In HIV-infected Subjects
In Brief
A Phase 2 clinical trial evaluating Rifaximin and Placebo for HIV. Completed, enrolled 46 participants across 3 sites.
Detailed 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 intestine. These studies will collect samples of the intestinal tract to look at the effects of Rifaximin in the study.
Study Details
Timeline
Interventions
subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily)
subject will receive three capsules of placebo by mouth twice daily.