Rifaximin for Chronic Immune Activation in People With HIV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01866826|
Recruitment Status : Completed
First Posted : June 3, 2013
Results First Posted : February 24, 2020
Last Update Posted : February 26, 2020
- 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 Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 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|
|Actual Study Start Date :||January 18, 2013|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||February 28, 2018|
Experimental: HIV Infected Subjects
Human immunodeficiency virus (HIV) infected subjects with viral suppression on antiretroviral (ART). Double-blinded/placebo controlled trial with cross-over design. Rifaximin
subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily)
Other Name: Xifaxan
Placebo Comparator: HIV Infected Subjects Placebo
HIV infected subjects with viral suppression on ART. Double-blinded/placebo controlled trial with cross-over design. Placebo
subject will receive three capsules of placebo by mouth twice daily.
- Changes in Soluble Cluster of Differentiation 14 (sCD14) Levels Between the Placebo and Rifaximin Phases of the Study [ Time Frame: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2 ]One sample Wilcoxon statistic was applied to evaluate the difference on treatment phases between the placebo and Rifaximin.
- Number of Participants With Viral (HIV-1)-Ribonucleic Acid (RNA) Elevated by Greater Than 50 Copies/ml Plasma at the End of the Rifaximin or Placebo Phase [ Time Frame: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2 ]HIV-1-RNA levels were assessed by using the single copy assay or the traditional HIV Branched Deoxyribonucleic Acid bDNA assay to determine elevations in HIV-1 RNA >50 copies/ml plasma at the end of the Rifaximin or placebo phase. Differences were tested by using both the Wilcoxon and the t-test.
- Changes in Soluble Markers of Inflammation Between the Placebo and Rifaximin Phases of the Study [ Time Frame: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2 ]Changes in soluble marker of inflammation Interleukin 6 (IL6) between the placebo and rifaximin phases of the study. Differences will be tested by using both the Wilcoxon and the t-test.
- Changes in Cellular Markers of Immune Activation Between the Placebo and Rifaximin Phases of the Study [ Time Frame: Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2 ]Changes in cellular markers of immune activation (IA) is defined as changes in the percentage of cluster of differentiation 4 (CD4) + or cluster of differentiation 8 (CD8)+ T cells that express human leukocyte antigen - antigen D Related (HLA-DR) and cluster of differentiation 38 (CD38). Differences will be tested by using both the Wilcoxon and the t-test.
- Number of Participants With Serious and Non-Serious Adverse Events [ Time Frame: From baseline until up to approximately 14 weeks ]The number of participants with serious and non-serious adverse events that were possibly related to Rifaximin or Placebo as assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
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)|