Phase 2 N=73 Randomized Treatment

Rifaximin as a Modulator of Microbial Translocation and Immune Activation

HIV-1 Infection

Bottom Line

View on ClinicalTrials.gov: NCT01466595 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2013

Primary outcome: Primary: Change in CD8+ T-cell Activation From Baseline to Week 4 — 0.00; 0.64 percentage HLA-DR+/CD38+ of CD8+ — p=0.028

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rifaximin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in CD8+ T-cell Activation From Baseline to Week 4	0.00; 0.64	0.028 sig
SECONDARY Change in D-dimer From Baseline to Week 4	0.00; -0.03	—
SECONDARY Change in IL-6 From Baseline to Week 4	-0.03; 0.05	—
SECONDARY Change in LPS From Baseline to Week 4	0.00; -0.01	—
SECONDARY Change in hsCRP From Baseline to Week 4	-0.08; -0.09	—
SECONDARY Change in sCD14 From Baseline to Week 4	-0.03; -0.03	—
SECONDARY Change in Peripheral B7hi CD4+ T-cell From Baseline to Week 4	-0.40; 0.00	—
SECONDARY Change in %CD38+ of CD4+ From Baseline to Week 4	0.89; 0.91	—
SECONDARY Change in %CD38+ of CD8+ From Baseline to Week 4	0.21; 0.66	—
SECONDARY Change in %Ki67+ of CD4+ From Baseline to Week 4	-0.17; 0.05	—
SECONDARY Change in %Ki67+ of CD8+ From Baseline to Week 4	-0.12; 0.12	—
SECONDARY Change in %HLA-DR+/CD38+ of CD4+ From Baseline to Week 4	-0.15; 0.15	—
SECONDARY Change in CD38+ of CD8+ MFI From Baseline to Week 4	0.00; 0.03	—
SECONDARY Change in CD4 Count From Baseline to Week 4	-3.00; 11.25	—
SECONDARY Change in CD8+ T-cell Activation From Week 4 to Week 8	0.08; -0.71	—
SECONDARY Change in D-dimer From Week 4 to Week 8	-0.02; 0.03	—
SECONDARY Change in IL-6 From Week 4 to Week 8	-0.03; 0.06	—
SECONDARY Change in LPS From Week 4 to Week 8	-0.01; 0.00	—
SECONDARY Change in hsCRP From Week 4 to Week 8	-0.05; 0.23	—
SECONDARY Change in sCD14 From Week 4 to Week 8	-0.05; 0.02	—
SECONDARY Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 8	0.26; -0.02	—
SECONDARY Change in %CD38+ of CD4+ From Week 4 to Week 8	-0.84; 1.00	—
SECONDARY Change in %CD38+ of CD8+ From Week 4 to Week 8	-0.12; -1.20	—
SECONDARY Change in %Ki67+ of CD4+ From Week 4 to Week 8	0.21; -0.01	—
SECONDARY Change in %Ki67+ of CD8+ From Week 4 to Week 8	0.11; -0.08	—
SECONDARY Change in CD4 Activation Percent From Week 4 to Week 8	0.17; -0.53	—
SECONDARY Change in CD38+ of CD8+ MFI From Week 4 to Week 8	0.08; -0.71	—
SECONDARY Change in CD4 Count From Week 4 to Week 8	-9.50; -13.00	—
SECONDARY Change in CD8+ T-cell Activation From Week 4 to Week 12	-0.05; -0.77	—
SECONDARY Change in D-dimer From Week 4 to Week 12	-0.01; 0.07	—
SECONDARY Change in IL-6 From Week 4 to Week 12	0.02; 0.02	—
SECONDARY Change in LPS From Week 4 to Week 12	0.00; 0.03	—
SECONDARY Change in hsCRP From Week 4 to Week 12	0.09; 0.04	—
SECONDARY Change in sCD14 From Week 4 to Week 12	0.03; 0.02	—
SECONDARY Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 12	-0.07; -0.19	—
SECONDARY Change in %CD38+ of CD4+ From Week 4 to Week 12	-0.67; -0.54	—
SECONDARY Change in %CD38+ of CD8+ From Week 4 to Week 12	-0.93; -1.96	—
SECONDARY Change in %Ki67+ of CD4+ From Week 4 to Week 12	0.14; -0.22	—
SECONDARY Change in %Ki67+ of CD8+ From Week 4 to Week 12	0.13; -0.09	—
SECONDARY Change in CD4 Activation Percent From Week 4 to Week 12	-0.14; -0.50	—
SECONDARY Change in CD38+ of CD8+ MFI From Week 4 to Week 12	-0.02; -0.02	—
SECONDARY Change in CD4 Count From Week 4 to Week 12	0.00; -5.50	—
SECONDARY Primary Adverse Events	27; 9	—

Summary

This study is being done to see whether rifaximin, an antibiotic that works in the intestines, can lower the amount of germs in the intestines of HIV infected persons. It is possible that when the amount of these germs is lowered, an HIV-infected person's immune system will become less active and will have a better chance of recovering. Also, the study will evaluate the safety of using rifaximin in HIV-infected subjects.

Eligibility Criteria

Inclusion Criteria

HIV-1 infection
On ART for at least 96 weeks prior to study entry with a regimen that includes three or more antiretroviral medications. (Ritonavir ≤ 400 mg/day will not be considered a separate antiretroviral agent.)
No plans to change the antiretroviral regimen at least in the next 3 months after study entry.
CD4+ cell count 7.
Receipt of antimicrobial therapy within 30 days prior to study entry. (NOTE: Antimicrobial use for prophylaxis of opportunistic infections, e.g., azithromycin or trimethoprim-sulfamethoxazole, is allowed.)
Active infection requiring the use of antibiotics within 30 days prior to study entry.
Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation (e.g., allergy to rifampin).
Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to entry.
Use of any of the following medications for more than 3 consecutive days within the 60 days prior to study entry:
Immunosuppressives
Immune modulators
Antineoplastic agents
Probiotics
Anticoagulants
Vaccinations within 1 week prior to the pre-entry or study entry visits. (NOTE: Subjects are encouraged to get the flu vaccine prior to study pre-entry visit.)
Participation on any HIV immunotherapy/therapeutic vaccination trials within 6 months prior to study entry.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Breastfeeding.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01466595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.