SHIFT: Studying HIV Immunology After Fecal Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2022-06-30

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).

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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.

Conditions

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HIV/AIDS Dysbiosis Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.

Group Type PLACEBO_COMPARATOR

Placebo (for Fecal Inoculum Capsule)

Intervention Type BIOLOGICAL

Placebo capsule manufactured to mimic Fecal Inoculum Capsules

Antibiotic Placebo

Intervention Type DRUG

Placebo tablets manufactured to mimic antibiotics

Arm B

Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.

Group Type EXPERIMENTAL

Fecal Inoculum Capsule

Intervention Type BIOLOGICAL

Sieved fecal matter prepared in glycerol/saline solution

Antibiotic Placebo

Intervention Type DRUG

Placebo tablets manufactured to mimic antibiotics

Arm C

Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.

Group Type EXPERIMENTAL

Fecal Inoculum Capsule

Intervention Type BIOLOGICAL

Sieved fecal matter prepared in glycerol/saline solution

Antibiotic

Intervention Type DRUG

Antibiotic pre-treatment

Interventions

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Fecal Inoculum Capsule

Sieved fecal matter prepared in glycerol/saline solution

Intervention Type BIOLOGICAL

Placebo (for Fecal Inoculum Capsule)

Placebo capsule manufactured to mimic Fecal Inoculum Capsules

Intervention Type BIOLOGICAL

Antibiotic

Antibiotic pre-treatment

Intervention Type DRUG

Antibiotic Placebo

Placebo tablets manufactured to mimic antibiotics

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

1. Men and women ages 18 - 75 years.
2. HIV-1 positive:
3. Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria

1. 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)
2. Use of investigational therapies or investigational vaccines within 90 days prior to study entry
3. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
4. History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
5. History of positive HBsAg within 48 weeks prior to study entry
6. 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.
7. Current diagnosis of diabetes
8. BMI \>35
9. Either breastfeeding or pregnant within 24 weeks prior to study entry
10. Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment)
11. Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry.
12. Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed.
13. Diagnosed bacterial enteric infection within 30 days prior to study entry.
14. Acute diarrhea within 30 days of study entry.
15. Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No