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Rifaximin for Chronic Immune Activation in People With HIV
Phase 1, PHASE2 trial testing Rifaximin in HIV in 46 participants. Completed in 28 February 2018.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 18 January 2013 |
| Primary completion | 30 June 2016 |
| Estimated completion | 28 February 2018 |
| Sites | 3 locations across United States |
National Cancer Institute (NCI)
18 and older, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
One sample Wilcoxon statistic was applied to evaluate the difference on treatment phases between the placebo and Rifaximin.
| Group | Value | 95% CI |
|---|---|---|
| Rifaximin | 0.0067 | -0.0097 – 0.22 |
| Placebo | 0.0035 | -0.195 – 0.154 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Rifaximin | 0 | |
| Placebo | 0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Rifaximin | 7.94 | ± 3.89 |
| Placebo | 8.10 | ± 3.70 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Rifaximin | 10.00 | ± 5.34 |
| Placebo | 9.92 | ± 4.97 |
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 impor
| Group | Value | 95% CI |
|---|---|---|
| Rifaximin | 12 | |
| Placebo | 11 |
Time frame: From baseline until up to approximately 14 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Rifaximin | Placebo |
|---|---|---|---|
| Adenocarcinoma gastric | Gastrointestinal disorders | — | — |
| Spinal fracture | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Rifaximin | Placebo |
|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood creatinine increased | Investigations | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Hemorrhoids | Gastrointestinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Acute sinusitis | Infections and infestations | — | — |
| Amylase increased | Investigations | — | — |
| Anal examination abnormal | Gastrointestinal disorders | — | — |
| Anal fissure | Gastrointestinal disorders | — | — |
| Anal spasm | Gastrointestinal disorders | — | — |
| Bacterial vaginosis | Reproductive system and breast disorders | — | — |
| Blood alkaline phosphatase increased | Investigations | — | — |
| Blood bicarbonate abnormal | Investigations | — | — |
| Chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Chills | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Defecation urgency | Gastrointestinal disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Dysuria | Renal and urinary disorders | — | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — | — |
| Hematemesis | Gastrointestinal disorders | — | — |
| Hordeolum | Eye disorders | — | — |
| Hot flush | Vascular disorders | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — |
| Hypoglycemia | Metabolism and nutrition disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Influenza like illness | Respiratory, thoracic and mediastinal disorders | — | — |
| Iron deficiency anemia | Blood and lymphatic system disorders | — | — |
| Laceration | Injury, poisoning and procedural complications | — | — |
| Lethargy | General disorders | — | — |
| Lipase increased | Investigations | — | — |
Most-reported serious reactions: Adenocarcinoma gastric, Spinal fracture.
Data from ClinicalTrials.gov NCT01866826 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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