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Virus Therapy
Fecal Microbiota Transplantation for HIV (Gutsy Trial)
Phase 2
Recruiting
Research Sponsored by Jean-Pierre Routy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented HIV-1 infection by Western Blot, Enzyme Immuno Assay (EIA) or viral load assay
On ART for at least 3 years, and stable ART regimen for at least 3 months
Must not have
Current AIDS-related event or serious health condition including systemic infections in the last 3 months
Women who are planning to become or who are pregnant, or breast-feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial aims to see if Fecal Microbiota Transplantation (FMT) can reduce gut and body inflammation in people with HIV who have low CD4/CD8 ratios. The study
Who is the study for?
This trial is for adults over 18 with HIV who've been on ART for at least 3 years, have an undetectable viral load, and a low CD4/CD8 ratio indicating inflammation risks. They must understand French or English and agree to specific contraception methods if of childbearing potential.
What is being tested?
The study tests whether FMT capsules can reduce gut and systemic inflammation in people living with HIV compared to placebo capsules. It involves two groups: one receiving the FMT and the other a placebo, with treatments given twice over three weeks.
What are the potential side effects?
Potential side effects are not explicitly listed but may include gastrointestinal discomfort or changes in bowel habits due to alterations in gut bacteria from the FMT capsules.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tested positive for HIV.
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I have been on HIV medication for at least 3 years and on the same medication for the last 3 months.
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I cannot become pregnant due to menopause or surgery.
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I agree to use birth control as a man with a partner who can have children.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had AIDS-related health issues or serious infections in the last 3 months.
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I am pregnant, planning to become pregnant, or am breastfeeding.
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I have not been in a clinical trial or received experimental therapy in the last 6 months.
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I do not have severe illnesses or uncontrolled infections.
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I have an active Hepatitis B or C infection.
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I have used immune-modulators, antibiotics, or Morphine in the last 3 months.
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I have been diagnosed with diabetes according to Canadian guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
REG3α levels
Secondary study objectives
Changes in Plasma levels of anti-inflammatory markers
Changes in Plasma levels of pro-inflammatory markers
Changes in T activation in blood
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FMT capsulesExperimental Treatment1 Intervention
10 participants taking FMT. The study product consists of fecal microbiota capsules prepared by Dr. Silverman's team in London, Ontario, Canada. Dr. Silverman has received approval from Health Canada to evaluate FMT in patients with metastatic malignant melanoma or with fatty liver within a clinical trial setting (CTA control nos. 235387and 195078 respectively).
Approximately 30 to 40 capsules will be prepared from 80-100g of healthy human feces from a single healthy donor and administered as a single dose. Capsules will be prepared by a modified method as described by Kao et al, 201747,48 (see Investigator brochure).
Group II: Placebo capsulesPlacebo Group1 Intervention
10 participants taking Placebo. Placebo capsules contain microcrystalline cellulose, for equivalence in weight and color that will be encapsulated in gelatin capsules. Each capsule will be filled with approximatively 5.5g of microcrystalline cellulose, and encapsulated in size 0 and size 00 capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FMT capsules
2016
Completed Phase 3
~60
Find a Location
Who is running the clinical trial?
Jean-Pierre RoutyLead Sponsor
2 Previous Clinical Trials
110 Total Patients Enrolled
St. Joseph's Health Care LondonOTHER
27 Previous Clinical Trials
2,478 Total Patients Enrolled
Carolina Berini, Dr.Study DirectorMcGill University Health Centre/Research Institute of the McGill University Health Centre