Rifaximin for Chronic Immune Activation in People With HIV

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT01866826

Run by

National Cancer Institute (NCI)

People needed

46

Starts

2013-01-18

Expected to finish

2018-02-28

Last updated by the study team

2020-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Known bleeding diathesis (for example a diagnosis of hemophilia or Von Willebrand disease)
• Active drug use or alcohol abuse/dependence, which in the opinion of the investigators will interfere with the patients ability to participate in the study
• Serious illness requiring systemic treatment and/or hospitalization within 30 days of screening into the study
• Evidence of active opportunistic infections or neoplasms (excluding cutaneous basal cell carcinoma and squamous cell carcinoma) in the 6 months prior to randomization
• History of inflammatory bowel disease (Crohn's Disease, ulcerative colitis)
• Positive urine pregnancy test at screening (of child bearing potential).
• Breastfeeding
• Current imprisonment
• Concurrent immunomodulatory agents, including systemic corticosteroids in the 12 weeks prior to randomization. Topical, nasal or inhaled corticosteroid use is allowed
• Concomitant use of probiotics except yogurt
• Chronic antibiotic use such as tetracyclines for acne
• Vaccinations within 6 weeks of randomization
• Concomitant use of anticoagulants (other than aspirin and nonsteroidal anti-inflammatory drugs (NSAIDS)) is an exclusion criterion for subjects opting in for the colonoscopy. Aspirin and NSAIDs will be discontinued per each institutions requirement before the procedure.
• Child-Pugh Class C disease
• A prior history of Clostridium difficile colitis
• Any condition that precludes the safe administration of conscious sedation for endoscopy (such as decompensated lung or heart disease) will not be able to participate in the colonoscopy aspect of the protocol.

Where it is running

• Walter Reed National Medical Center — Bethesda, Maryland, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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