Rifaximin for Chronic Immune Activation in People With HIV
Status:
Completed
Trial end date:
2018-02-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Cancer Institute (NCI)
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID) University of Pittsburgh Walter Reed National Military Medical Center Walter Reed Navy MMC