Rifaximin for Chronic Immune Activation in People With HIV

• PARTICIPANT INCLUSION CRITERIA:

Patients who have agreed in the course of other research studies to have their records reviewed will have the following elements evaluated from their existing records: age, history of human immunodeficiency virus (HIV) infection, antiretroviral therapy (ART) history and viral loads prior to informed consent, or else these elements will be assessed after informed consent. All blood draws to assess eligibility will be completed after obtaining informed consent. To participate in this study the criteria listed below will need to be met.

• Subjects must be 18 years of age or older.
• Able and willing to provide written informed consent
• Must have a history of documented HIV infection.
• HIV infection if not previously documented at host institutions will need to be documented by a plasma human immunodeficiency virus (HIV) ribonucleic acid (RNA) viral load, rapid HIV test or any other licensed enzyme-linked immunosorbent assay (ELISA) test and confirmed by another test using a different method such as a rapid HIV test, Western Blot, HIV culture, HIV antigen, HIV pro-viral deoxyribonucleic acid (DNA) at any time prior to study entry.
• ART- treated subjects who are virologically suppressed for greater than or equal to 3 years (1095 days). To meet this criteria all documented viral loads in the 3 years (1095 days) prior to the screening visit must be below the lower limit of detection [LLD] using Food and Drug Administration (FDA)-approved standard assays (i.e. 60 mL/min, eGFR will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
• Confirmed serum glutamate pyruvate transaminase (SGPT)/serum glutamate oxaloacetate transferase (SGOT) less than or equal to 3 times the upper limit of normal (ULN)
• International Normalized Ratio (INR) less than or equal to the upper limit of normal (ULN) for the assay
• Negative urine pregnancy test of child bearing potential at randomization
• No evidence of active hepatitis B or hepatitis C (active hepatitis B will be defined as a positive hepatitis B surface antigen present on a single determination, whereas a positive result on hepatitis C RNA will be considered as evidence of active hepatitis C)

All routine laboratory testing used to determine safety will be completed within the 70 days prior to randomization.

EXCLUSION CRITERIA

• 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 a