SHIFT: Studying HIV Immunology After Fecal Transplant

Phase 1

Withdrawn

• Conditions: HIV/AIDS; Inflammation; Dysbiosis
• Interventions: Biological: Fecal Inoculum Capsule; Biological: Placebo (for Fecal Inoculum Capsule); Drug: Antibiotic Placebo; Drug: Antibiotic

• Registration Number: NCT03163784
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-23
• Study Start: 2018-06
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-13
• Last Update Posted: 2018-11-15
• Primary Completion: 2020-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm C	Fecal Inoculum Capsule	Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.
Arm B	Antibiotic Placebo	Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.
Arm A	Placebo (for Fecal Inoculum Capsule)	Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.
Arm C	Antibiotic	Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.
Arm A	Antibiotic Placebo	Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.
Arm B	Fecal Inoculum Capsule	Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.

Primary Outcome Measures

Name	Time	Method
FMT-related adverse events	30 weeks	Safety of FMT in stably suppressed HIV infected recipients on ART

Secondary Outcome Measures

Name	Time	Method
Microbiome structure	30 weeks	Identify and characterize how FMT alters enteric microbiome structure.
Immune and metabolic markers	30 weeks	Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.