SHIFT: Studying HIV Immunology After Fecal Transplant

NCT03163784 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 2016P002317
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

HIV/AIDS; Dysbiosis; Inflammation

Outcome Measures

Primary Outcomes (1)

• FMT-related adverse events

  Safety of FMT in stably suppressed HIV infected recipients on ART

  30 weeks

Secondary Outcomes (2)

• Immune and metabolic markers

  30 weeks

• Microbiome structure

  30 weeks

Study Arms (3)

Arm A

PLACEBO COMPARATOR

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

Biological: Placebo (for Fecal Inoculum Capsule); Drug: Antibiotic Placebo

Arm B

EXPERIMENTAL

Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.

Biological: Fecal Inoculum Capsule; Drug: Antibiotic Placebo

Arm C

EXPERIMENTAL

Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.

Biological: Fecal Inoculum Capsule; Drug: Antibiotic

Interventions

Fecal Inoculum Capsule BIOLOGICAL

Sieved fecal matter prepared in glycerol/saline solution

Arm B; Arm C

Placebo (for Fecal Inoculum Capsule) BIOLOGICAL

Placebo capsule manufactured to mimic Fecal Inoculum Capsules

Also known as: Placebo

Arm A

Antibiotic DRUG

Antibiotic pre-treatment

Arm C

Antibiotic Placebo DRUG

Placebo tablets manufactured to mimic antibiotics

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Dysbiosis; Inflammation

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Douglas Kwon, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 23, 2017
• Study Start: June 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2022
• Last Updated: November 15, 2018

Record last verified: 2018-11