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HIV InfectionsPhase 1NCT04058392

Camu Camu in ART-treated People Living with HIV

A Phase 1 study testing Camu Camu Capsules in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Persons living with HIV and receiving antiretroviral therapy (ART) remain with inflammation leading to higher risks of cardiovascular diseases, fatty liver and cancer. It has been observed in colitis and in HIV infection that abnormal composition of the gut microbes and leaky gut induce inflammation contributing to… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Camu Camu Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
9 Nov 2020to 20 Jul 2022
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Participants are not eligible to participate in the study if they meet any of the following conditions:
  • Known allergy/hypersensitivity to Camu Camu.
  • Current AIDS-related event or serious health condition including systemic infections in the last 3 months.
  • Severe systemic diseases (e.g. uncontrolled hypertension, chronic renal failure), or active uncontrolled infections.
  • Co-infection with active Hepatitis B or C Virus.
  • Current use or have used in the past 3 months: immune-modulatory agents/chemotherapeutics, prophylactic antibiotics35/antibiotics, proton pump inhibitors, phosphate binders, Metformin or Morphine as these drugs can interact with vitamin C or modulate gut microbiota.
Show all 14Show fewer
  • Diagnosis of diabetes mellitus (HbA1c≥6.5%) as defined by the Canadian Clinical Practice Guidelines for the Prevention and Management of Diabetes42.
  • Frequent use of polyphenol-rich prebiotics (e.g. cranberry and CC powders and/or capsules) in the last 12 months.
  • Statin or other anti-cholesterol treatment use in the last 3 months.
  • Recent changes in dietary habits, intermittent fasting, chronic constipation or laxative use as these can affect gut microbiota.
  • Psychiatric or cognitive disturbance or any illness that could preclude compliance with the study.
  • Current participation in an experimental therapy study or receipt of experimental therapy within the last 6 months.
  • Women who are pregnant, planning to become pregnant, or breast-feeding.
  • A score of higher than 8 on a Full AUDIT questionnaire (See Appendix 1) at the screening visit, suggesting an alcohol abuse problem.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Mcgill University Health Center

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: FULL TITLE: Camu Camu Effects on Circulating LPS and Systemic Immune Activation in ART-treated Participants: the Camu Camu Pilot Study

Persons living with HIV and receiving antiretroviral therapy (ART) remain with inflammation leading to higher risks of cardiovascular diseases, fatty liver and cancer. It has been observed in colitis and in HIV infection that abnormal composition of the gut microbes and leaky gut induce inflammation contributing to diabetes, fatty liver and cardiovascular risks. Abundance of Akkermansia muciniphila in stool, a type of good bacteria acting as a shield on the gut barrier has been shown to prevent obesity, diabetes and to improve cancer treatment response. Health food (prebiotic) increases the frequency of A. muciniphila in overweight individuals.

Dr Marette, a study collaborator from Laval University, has recently published (Gut, 2018) that an extract from a Brazilian fruit called Camu Camu (CC) protects mice from obesity, reduce LPS, a marker for passage of microbes from the gut into the blood and decreases inflammation in association with the frequency of A. muciniphila in stools. The extract of CC is sold in nutritional stores to regulate body fat.

Read more

The investigators will invite 22 participants to take 2 capsules of CC daily for 12 weeks in addition to their ART. CC tolerance and changes in blood and stools for inflammation and microbe composition will be evalutated at the end of the 12-week treatment and 8 weeks post-intake. An optional sub study will assess the changes of gut barrier by doing biopsies by colonoscopy.

CC is expected to beassociated with an enrichment of A. muciniphila in stools, combined with reduced gut damage and inflammation.

Conditions
HIV Infections
Being tested
Camu Camu Capsules
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camu Camu CapsulesBiological

    Camu Camu powder encapsulated (500mg each). 2 capsules per day will be used for this study

Study groups in NCT04058392
Study groupRoleWhat they receive
Camu CamuExperimentalAssessments will be done at baseline, during and after 12 weeks of Camu Camu intake.
Receives: Biological: Camu Camu Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of the plasma marker of microbial translocation LPS, assessed using ELISA.

    Measured: 12 weeks

Secondary outcomes (13)

  1. Safety and tolerability of CC

    measured by evaluating adverse events, hematology, and serum chemistries over the course of the study. These evaluations will include HIV viral load, glucose levels, a lipid profile and plasma levels of hsCRP and D-dimer.

    Measured: 20 weeks

  2. Changes in gut integrity markers I-FABP, and sST2, measured by ELISA

    Measured: 12 weeks and 20 weeks

  3. Changes in microbial translocation marker 1-3-b-D-Glucan assessed using the Fungitell assay

    Measured: 12 weeks and 20 weeks.

  4. Changes in pro-inflammatory markers (IL-1β, IL-6, IL-8, IL-18. IP-10, IL-17A and F, IL-22, and soluble CD14) and anti-inflammatory markers (IL-10) assessed by ELISA.

    Measured: 12 weeks and 20 weeks

  5. Changes in T-cell and monocyte activation levels assessed by flow cytometry using markers CD38, HLA-DR and PD-1

    Measured: 12 weeks and 20 weeks

  6. Changes in A. muciniphila levels in stools using qPCR

    Measured: 12 weeks and 20 wekks

  7. Changes in microbiota composition and diversity in stools assessed using 16s rDNA sequencing

    Measured: 12 weeks and 20 wekks

  8. Changes in HIV reservoir size in blood assessed by PCR

    Measured: 12 weeks and 20 wekks

  9. Evaluate intra-patient variability using data from two baseline visits, approximately two weeks apart from each other to confirm reliability of baseline results.

    Measured: 2 weeks

  10. Changes in gut mucosa architecture in a subset of participants who will consent to have colon biopsies before and at the end of the 12 weeks of CC treatment.

    Measured: 12 weeks

  11. Changes in inflammation in gut mucosa biopsy assessed by myeloperoxidase staining before and at the end of the 12 weeks of CC treatment

    Measured: 12 weeks

  12. Changes in HIV reservoir size in biopsies using qPCR

    Measured: 12 weeks

  13. Association between baseline gut microbiota composition (16S rDNA sequencing), and markers of gut integrity (I-FABP, tissue staining) and inflammation (T-cell activation, inflammatory cytokines).

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2019
  2. Study start9 Nov 2020
  3. Primary completion20 Jul 2022
  4. Study completion20 Jul 2022

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04058392
Sponsor's protocol ID
CTNPT 032
Status last verified
Nov 2024
First submitted
6 May 2019
Last updated
20 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anhe FF, Nachbar RT, Varin TV, Trottier J, Dudonne S, Le Barz M, Feutry P, Pilon G, Barbier O, Desjardins Y, Roy D, Marette A. Treatment with camu camu (Myrciaria dubia) prevents obesity by altering the gut microbiota and increasing energy expenditure in diet-induced obese mice. Gut. 2019 Mar;68(3):453-464. doi: 10.1136/gutjnl-2017-315565. Epub 2018 Jul 31.

    PubMed 30064988

  • Brenchley JM, Price DA, Schacker TW, Asher TE, Silvestri G, Rao S, Kazzaz Z, Bornstein E, Lambotte O, Altmann D, Blazar BR, Rodriguez B, Teixeira-Johnson L, Landay A, Martin JN, Hecht FM, Picker LJ, Lederman MM, Deeks SG, Douek DC. Microbial translocation is a cause of systemic immune activation in chronic HIV infection. Nat Med. 2006 Dec;12(12):1365-71. doi: 10.1038/nm1511. Epub 2006 Nov 19.

    PubMed 17115046

  • Mehraj V, Jenabian MA, Ponte R, Lebouche B, Costiniuk C, Thomas R, Baril JG, LeBlanc R, Cox J, Tremblay C, Routy JP; Montreal Primary HIV Infection, the Canadian Long-Term Non-Progressors Study Groups. The plasma levels of soluble ST2 as a marker of gut mucosal damage in early HIV infection. AIDS. 2016 Jun 19;30(10):1617-27. doi: 10.1097/QAD.0000000000001105.

    PubMed 27045377

  • Jenabian MA, El-Far M, Vyboh K, Kema I, Costiniuk CT, Thomas R, Baril JG, LeBlanc R, Kanagaratham C, Radzioch D, Allam O, Ahmad A, Lebouche B, Tremblay C, Ancuta P, Routy JP; Montreal Primary infection and Slow Progressor Study Groups. Immunosuppressive Tryptophan Catabolism and Gut Mucosal Dysfunction Following Early HIV Infection. J Infect Dis. 2015 Aug 1;212(3):355-66. doi: 10.1093/infdis/jiv037. Epub 2015 Jan 23.

    PubMed 25616404

  • Isnard S, Fombuena B, Ouyang J, Royston L, Lin J, Bu S, Sheehan N, Lakatos PL, Bessissow T, Chomont N, Klein M, Lebouche B, Costiniuk CT, Routy B, Marette A, Routy JP; Camu Camu Study Group. Camu Camu effects on microbial translocation and systemic immune activation in ART-treated people living with HIV: protocol of the single-arm non-randomised Camu Camu prebiotic pilot study (CIHR/CTN PT032). BMJ Open. 2022 Jan 17;12(1):e053081. doi: 10.1136/bmjopen-2021-053081.

    PubMed 35039291

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Camu Camu Capsules in people with HIV Infections, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

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 0 inclusion and 14 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 20 Nov 2024. 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 Canada. 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?

Reduction of the plasma marker of microbial translocation LPS, assessed using ELISA. (time frame: 12 weeks). 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 NCT04058392, which also lists 5 linked publications.

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 20 Nov 2024.

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