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The study closed because of shifting research priorities and interests.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Placebo Comparator | Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment. |
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| Arm B | Experimental | Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment. |
|
| Arm C | Experimental | Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Inoculum Capsule | Biological | Sieved fecal matter prepared in glycerol/saline solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| FMT-related adverse events | Safety of FMT in stably suppressed HIV infected recipients on ART | 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Immune and metabolic markers | Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels. | 30 weeks |
| Microbiome structure | Identify and characterize how FMT alters enteric microbiome structure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Kwon, MD, PhD | Massachusetts General Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D064806 | Dysbiosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Placebo (for Fecal Inoculum Capsule) | Biological | Placebo capsule manufactured to mimic Fecal Inoculum Capsules |
|
|
| Antibiotic | Drug | Antibiotic pre-treatment |
|
| Antibiotic Placebo | Drug | Placebo tablets manufactured to mimic antibiotics |
|
| 30 weeks |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |