NCT03163784

SHIFT: Studying HIV Immunology After Fecal Transplant

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV/AIDS
• Dysbiosis
• Inflammation

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Inoculum Capsule	Sieved fecal matter prepared in glycerol/saline solution
BIOLOGICAL	Placebo (for Fecal Inoculum Capsule)	Placebo capsule manufactured to mimic Fecal Inoculum Capsules
DRUG	Antibiotic	Antibiotic pre-treatment
DRUG	Antibiotic Placebo	Placebo tablets manufactured to mimic antibiotics

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-06-01
• Completion: 2022-06-01
• First posted: 2017-05-23
• Last updated: 2018-11-15

Regulatory

• FDA-regulated drug study