Rifaximin for Chronic Immune Activation in People With HIV

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.

Conditions

• HIV

Interventions

DRUG

Rifaximin

subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily)

OTHER

Placebo

subject will receive three capsules of placebo by mouth twice daily.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• University of Pittsburgh

  collaborator OTHER

• Walter Reed National Military Medical Center

  collaborator FED

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Frank Maldarelli, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-18

Primary Completion

2016-06-30

Completion

2018-02-28

FDA Drug

Yes

Countries

• United States

Study Locations