Rifaximin for Chronic Immune Activation in People With HIV
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|ClinicalTrials.gov Identifier: NCT01866826|
Recruitment Status : Unknown
Verified December 15, 2016 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ).
Recruitment status was: Active, not recruiting
First Posted : June 3, 2013
Last Update Posted : January 25, 2017
- 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.
- To see if Rifaximin can reduce bacteria-related inflammation in people with HIV.
- Individuals at least 18 years of age who have HIV infection and are taking medications to treat it.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Rifaximin/ Placebo||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||January 18, 2013|
|Actual Primary Completion Date :||June 30, 2016|
|Estimated Study Completion Date :||May 18, 2018|
Experimental: HIV Infected Subjects
HIV infected subjects with viral suppression on ART.Double-blinded/placebo controlled trial with cross-overdesign.
Drug: Rifaximin/ Placebo
subject will receive either three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily) or will receive three capsules of placebo by mouth twice daily.
- The primary objective is to compare the changes in sCD14 levels between the placebo and phases of the study [ Time Frame: End of Study Phase 2 ]
- To compare the changes in HIV-1-RNA levels (using the single copy assay or the traditional HIV bDNA assay) between the placebo and the rifaximin phases of the study. [ Time Frame: End of Phase 2 ]
- To compare changes in soluble markers of inflammation between the placebo and rifaximin phases of the study. [ Time Frame: End of Phase 2 ]
- To compare the changes in cellular markers of IA (changes in the proportion ofCD4+ or CD8+ T cells that express HLA-DR and/or CD38) during the rifaximin phase of the study and compare it with the changes in cellular markers of activation during ... [ Time Frame: End of Phase 2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866826
|United States, Maryland|
|Walter Reed National Medical Center|
|Bethesda, Maryland, United States, 20301|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Frank Maldarelli, M.D.||National Cancer Institute (NCI)|