SHIFT: Studying HIV Immunology After Fecal Transplant

Study Overview
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Brief Summary
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SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on stable antiretroviral therapy (ART).

Detailed Description
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This study is designed to test the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV infected individuals on stable antiretroviral therapy (ART). Additionally, the study will examine potential effects of FMT on HIV immune activation, which has been linked to HIV disease progression.

Official Title
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SHIFT: Studying HIV Immunology After Fecal Transplant

Conditions
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HIV/AIDS, Dysbiosis, Inflammation

Intervention / Treatment
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* Biological: Fecal Inoculum Capsule
* Biological: Placebo (for Fecal Inoculum Capsule)
* Drug: Antibiotic
* Drug: Antibiotic Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ages 18 - 75 years. HIV-1 positive: Ability and willingness of participant or legal guardian/representative to provide informed consent. Exclusion Criteria: Patients with a history of significant allergy to tree nuts, peanuts, shellfish, and/or eggs, vancomycin, levofloxacin, or metronidazole, chocolate/cocoa or gelatin; or unwillingness to ingest gelatin (in placebo capsules) Use of investigational therapies or investigational vaccines within 90 days prior to study entry Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry. History of positive HBsAg within 48 weeks prior to study entry Liver cirrhosis, history of C. difficile infection, history of inflammatory bowel disease, bariatric surgery, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy. Current diagnosis of diabetes BMI >35 Either breastfeeding or pregnant within 24 weeks prior to study entry Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment) Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry. Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed. Diagnosed bacterial enteric infection within 30 days prior to study entry. Acute diarrhea within 30 days of study entry. Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm A<br>Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment. | Biological: Placebo (for Fecal Inoculum Capsule)<br>* Placebo capsule manufactured to mimic Fecal Inoculum Capsules<br>* Other names: Placebo;Drug: Antibiotic Placebo<br>* Placebo tablets manufactured to mimic antibiotics<br>|
| Experimental: Arm B<br>Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment. | Biological: Fecal Inoculum Capsule<br>* Sieved fecal matter prepared in glycerol/saline solution<br>Drug: Antibiotic Placebo<br>* Placebo tablets manufactured to mimic antibiotics<br>|
| Experimental: Arm C<br>Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment. | Biological: Fecal Inoculum Capsule<br>* Sieved fecal matter prepared in glycerol/saline solution<br>Drug: Antibiotic<br>* Antibiotic pre-treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FMT-related adverse events | Safety of FMT in stably suppressed HIV infected recipients on ART | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune and metabolic markers | Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels. | 30 weeks | 
| Microbiome structure | Identify and characterize how FMT alters enteric microbiome structure. | 30 weeks |