HIV/AIDSPhase 1/2SHIFTNCT03163784
SHIFT: Studying HIV Immunology After Fecal Transplant
A Phase 1/2 study testing Fecal Inoculum Capsule and Antibiotic in people with HIV/AIDS and Dysbiosis, run by Massachusetts General Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV/AIDS, Dysbiosis, Inflammation
- What is being tested?
- Fecal Inoculum Capsule and Antibiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Jun 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 18 - 75 years.
- HIV-1 positive:
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
Who cannot join
- 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.
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- 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.
About this study
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).
Read the 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
- Being tested
- Fecal Inoculum Capsule, Placebo (for Fecal Inoculum Capsule), Antibiotic, Antibiotic Placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Dysbiosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Inoculum CapsuleBiological
Sieved fecal matter prepared in glycerol/saline solution
Placebo (for Fecal Inoculum Capsule)Biological
Also called Placebo
Placebo capsule manufactured to mimic Fecal Inoculum Capsules
AntibioticDrug
Antibiotic pre-treatment
Antibiotic PlaceboDrug
Placebo tablets manufactured to mimic antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Placebo comparator | Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment. Receives: Biological: Placebo (for Fecal Inoculum Capsule); Drug: Antibiotic Placebo |
| Arm B | Experimental | Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment. Receives: Biological: Fecal Inoculum Capsule; Drug: Antibiotic Placebo |
| Arm C | Experimental | Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment. Receives: Biological: Fecal Inoculum Capsule; Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
FMT-related adverse events
Safety of FMT in stably suppressed HIV infected recipients on ART
Measured: 30 weeks
Secondary outcomes (2)
Immune and metabolic markers
Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.
Measured: 30 weeks
Microbiome structure
Identify and characterize how FMT alters enteric microbiome structure.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startJun 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: The study closed because of shifting research priorities and interests.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DOUGLAS KWON, Massachusetts General Hospital
- Investigators
- Douglas Kwon, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163784
- Sponsor's protocol ID
- 2016P002317
- Acronym
- SHIFT
- Status last verified
- Nov 2018
- First submitted
- 18 May 2017
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SHIFT: Studying HIV Immunology After Fecal Transplant
- ClinicalTrials.gov ID
- NCT03163784
- Acronym / sponsor ID
- SHIFT / 2016P002317
- Conditions
- HIV/AIDS, Dysbiosis, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study closed because of shifting research priorities and interests.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Placebo comparator | Biological: Placebo (for Fecal Inoculum Capsule), Drug: Antibiotic PlaceboWeekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment. |
| Arm B | Experimental | Biological: Fecal Inoculum Capsule, Drug: Antibiotic PlaceboWeekly Fecal Inoculum Capsule treatment with placebo pre-treatment. |
| Arm C | Experimental | Biological: Fecal Inoculum Capsule, Drug: AntibioticWeekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women ages 18 - 75 years.
- HIV-1 positive:
- Ability and willingness of participant or legal guardian/representative to provide informed consent.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Inoculum CapsuleSieved fecal matter prepared in glycerol/saline solution | Biological | Arm B, Arm C |
| Placebo (for Fecal Inoculum Capsule)Also: PlaceboPlacebo capsule manufactured to mimic Fecal Inoculum Capsules | Biological | Arm A |
| AntibioticAntibiotic pre-treatment | Drug | Arm C |
| Antibiotic PlaceboPlacebo tablets manufactured to mimic antibiotics | Drug | Arm A, Arm B |
Primary outcome
FMT-related adverse events
Time frame: 30 weeks
Safety of FMT in stably suppressed HIV infected recipients on ART
2 secondary outcomes
Immune and metabolic markers
Time frame: 30 weeks
Microbiome structure
Time frame: 30 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Kwon, MD, PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Inoculum Capsule and Antibiotic in people with HIV/AIDS and Dysbiosis, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FMT-related adverse events (time frame: 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.