HIV-1-infectionPhase 1NCT03329560
Safety of FMT Using Oral Encapsulated PRIM-DJ2727 in HIV
A Phase 1 study testing Oral fecal microbiota transplantation in people with HIV-1-infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Oral fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2018to 8 Oct 2019
- Phase
- Phase 1
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection, documented by any licensed HIV test
- Male subjects ≥ 18 years of age
- Identify as MSM (men who have sex with men)
- Currently on continuous ART for ≥24 weeks prior to study entry with no change in the ART regimen within the 12 weeks prior to study
- Ability and willingness of the participating subject to sign the informed consent form
- No plan to change ART regimen for the study duration
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- Screening CD4+ cell count >350 cells/mm3 obtained within 45 days prior to study entry
- HIV RNA < 20 copies/ml for ≥12 weeks (1 blip of < 500 copies/ml will be permitted)
- Absolute neutrophil count ≥ 1000 cells/mm3
Who cannot join
- Initiation of ART during acute/early HIV infection (within 6 months of HIV seroconversion)
- Co-infection with Hepatitis B (positive HBsAg or positive HBcAb total with detectable HBV DNA levels) or Hepatitis C (positive HCV IgG with detectable HCV RNA levels)
- Use of antibiotics 60 days prior to the study entry
- Use of investigational therapies or vaccines 60 days prior to the study entry
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
- Cirrhosis, inflammatory bowel disease, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy
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- Diabetes mellitus
- Any episode of acute or persistent diarrhea within 60 days prior to study entry
- Use of any of the following medications/products for more than 3 consecutive days within the 60 days prior to study entry: Immunosuppressives, Immune modulators, Antineoplastic agents (except for topical agents for skin cancer), Probiotics and prebiotics (supplements and products).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy
The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.
- Conditions
- HIV-1-infection
- Being tested
- Oral fecal microbiota transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral fecal microbiota transplantationBiological
Also called PRIM-DJ2727
All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool.
| Study group | Role | What they receive |
|---|---|---|
| Oral fecal microbiota transplantation | Experimental | All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool. Receives: Biological: Oral fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events related to study drug
Measured: 52 weeks
Cumulative of adverse events related to study drug
Measured: 52 weeks
Severity of adverse events related to study drug
Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.
Measured: 52 weeks
Secondary outcomes (5)
Change in the intestinal microbiome diversity
Measured: week 0, week 6
Change in the intestinal microbiome abundance of genera
Measured: week 0, week 6
Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels
Measured: week 0, week 6
Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels
Measured: week 0, week 6
Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)
Measured: week 0, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start12 Apr 2018
- Primary completion8 Oct 2019
- Study completion8 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Netanya Utay, The University of Texas Health Science Center, Houston
- Investigators
- Netanya S Utay, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329560
- Sponsor's protocol ID
- HSC-MS-17-0782
- Status last verified
- May 2020
- First submitted
- 30 Oct 2017
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Utay NS, Monczor AN, Somasunderam A, Lupo S, Jiang ZD, Alexander AS, Finkelman M, Vigil KJ, Lake JE, Hanson B, DuPont HL, Arduino RC. Evaluation of Six Weekly Oral Fecal Microbiota Transplants in People with HIV. Pathog Immun. 2020 Dec 30;5(1):364-381. doi: 10.20411/pai.v5i1.388. eCollection 2020.
PubMed 33501400
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Fecal Microbiota Transplant Using Oral Encapsulated PRIM-DJ2727 in HIV-infected Persons on Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT03329560
- Acronym / sponsor ID
- HSC-MS-17-0782
- Conditions
- HIV-1-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 8 Oct 2019 (actual)
- Study completion
- 8 Oct 2019 (actual)
- First posted
- 6 Nov 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.
The purpose of this study is to determine whether oral fecal microbiota transplantation (FMT) is safe for people with human immunodeficiency virus (HIV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral fecal microbiota transplantation | Experimental | Biological: Oral fecal microbiota transplantationAll subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- HIV-1 infection, documented by any licensed HIV test
- Male subjects ≥ 18 years of age
- Identify as MSM (men who have sex with men)
- Currently on continuous ART for ≥24 weeks prior to study entry with no change in the ART regimen within the 12 weeks prior to study
- Ability and willingness of the participating subject to sign the informed consent form
Key exclusion criteria (9 listed)
- Initiation of ART during acute/early HIV infection (within 6 months of HIV seroconversion)
- Co-infection with Hepatitis B (positive HBsAg or positive HBcAb total with detectable HBV DNA levels) or Hepatitis C (positive HCV IgG with detectable HCV RNA levels)
- Use of antibiotics 60 days prior to the study entry
- Use of investigational therapies or vaccines 60 days prior to the study entry
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to 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 |
|---|---|---|
| Oral fecal microbiota transplantationAlso: PRIM-DJ2727All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool. | Biological | Oral fecal microbiota transplantation |
Primary outcome
Number of participants with adverse events related to study drug
Time frame: 52 weeks
Cumulative of adverse events related to study drug
Time frame: 52 weeks
Severity of adverse events related to study drug
Time frame: 52 weeks
Severity of adverse events will be based on Division of AIDS (DAIDS) grading criteria.
5 secondary outcomes
Change in the intestinal microbiome diversity
Time frame: week 0, week 6
Change in the intestinal microbiome abundance of genera
Time frame: week 0, week 6
Change in systemic inflammation as assessed by interleukin 6 (IL-6) levels
Time frame: week 0, week 6
Change in microbial translocation as assessed by soluble cluster of differentiation (CD14) levels
Time frame: week 0, week 6
Change in gut barrier integrity as assessed by intestinal fatty acid binding protein (I-FABP)
Time frame: week 0, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 33501400Utay NS, Monczor AN, Somasunderam A, Lupo S, Jiang ZD, Alexander AS, Finkelman M, Vigil KJ, Lake JE, Hanson B, DuPont HL, Arduino RC. Evaluation of Six Weekly Oral Fecal Microbiota Transplants in People with HIV. Pathog Immun. 2020 Dec 30;5(1):364-381. doi: 10.20411/pai.v5i1.388. eCollection 2020.
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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.
Netanya S Utay, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral fecal microbiota transplantation in people with HIV-1-infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 9 inclusion and 9 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: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events related to study drug (time frame: 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329560, which also lists 1 linked publication.
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 27 May 2020.