Microbiota Restoration Therapy in HIV With Repeated Low-Dose Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-10-31

Brief Summary

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Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with nutritional interventions exert limited immunologic effects, but a deep understanding of how these interventions could ameliorate gut dysbiosis and influence health among HIV-infected individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio\<1 will be included and randomized to either repeated low-dose oral fecal microbiota transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio, inflammatory markers, T cell activation and markers of enterocyte barrier function through week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint will be studied by combination of untargeted mass spectrometry and two different and complementary separation techniques in bacterial and plasma samples.

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Detailed Description

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Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FMT

Fecal microbiota capsules (provided by Openbiome).

Dosage:

* Induction: 10 capsules (single dose)
* Maintenance: 5 capsules, weekly, during 7 weeks.

Group Type EXPERIMENTAL

FMT

Intervention Type BIOLOGICAL

Capsules with fecal microbiota from healthy donors

Placebo

Placebo capsules (provided by Openbiome).

Dosage:

* Induction: 10 capsules (single dose)
* Maintenance: 5 capsules, weekly, during 7 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo capsules

Interventions

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FMT

Capsules with fecal microbiota from healthy donors

Intervention Type BIOLOGICAL

Placebo

Placebo capsules

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* On stable antiretroviral therapy with plasma HIV RNA \<20 copies/mL during at least 48 weeks.
* CD4/CD8 ratio \<1

Exclusion Criteria

* Pregnancy
* Gastrointestinal diseases, including cirrhosis
* Active infections, including HCV
* EBV and/or CMV negative patients (donors are not screened for EBV/CMV).
* Planned used of chemotherapy or antibiotics
* Allergy to sodium chloride or glycerol (the former components are capsule ingredients Generally Recognized As Safe (GRAS)
* Current or planned use of antimicrobial agents (including prophylactic treatments against P. jiroveci) other than ART.
* Neutropenia \<500 cells/uL or CD4 counts \<350 cells/uL
* Patients unable to give informed consent
* Patients unable to comply with the protocol requirements
* Predicted death within time period of follow-up
* Any other condition for which the treating physician thinks the treatment may pose a health risk
* Dysphagia: oropharyngeal, esophageal, functional, neuromuscular (e.g. stroke, multiple sclerosis, ALS)
* History of aspiration
* History of gastroparesis

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No