SHIFT: Studying HIV Immunology After Fecal Transplant

Inflammation Clinical Trial

— SHIFT  

Official title:

SHIFT: Studying HIV Immunology After Fecal Transplant

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03163784
• Other study ID #: 2016P002317
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: June 2018
• Est. completion date: June 2022

Study information

• Verified date: November 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• HIV/AIDS
• Inflammation

Intervention

Biological:
• Fecal Inoculum Capsule
Sieved fecal matter prepared in glycerol/saline solution
• Placebo (for Fecal Inoculum Capsule)
Placebo capsule manufactured to mimic Fecal Inoculum Capsules

Drug:
• Antibiotic
Antibiotic pre-treatment
• Antibiotic Placebo
Placebo tablets manufactured to mimic antibiotics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FMT-related adverse events	Safety of FMT in stably suppressed HIV infected recipients on ART	30 weeks
Secondary	Immune and metabolic markers	Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.	30 weeks
Secondary	Microbiome structure	Identify and characterize how FMT alters enteric microbiome structure.	30 weeks