Camu Camu in ART-treated People Living with HIV

Overseen By Jean-Pierre Routy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Must be taking: Antiretroviral therapy

Must not be taking: Antibiotics, Metformin, Morphine, others

Disqualifiers: AIDS, Hepatitis B/C, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current antiretroviral therapy (ART). However, if you are using certain medications like immune-modulatory agents, antibiotics, or Metformin, you may not be eligible to participate.

Is Camu Camu generally safe for human use?

The safety of Camu Camu, like many complementary and alternative medicine products, is not well-documented, and while they are often considered low risk, there can be adverse reactions and interactions with other drugs. It's important to be cautious and consult with a healthcare provider before using such supplements. ^{1 2 3 4 5}

How does this treatment differ from other treatments for Mycoplasma infections?

The treatment being studied may be unique because Mycoplasma infections, like those caused by Mycoplasma bovis, often do not respond to conventional antibiotics, suggesting a need for alternative approaches. This could involve targeting the specific mechanisms of Mycoplasma or using novel administration routes to effectively manage the infection. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests if taking Camu Camu (CC) capsules can help people with HIV reduce inflammation. The goal is to see if CC increases good gut bacteria, which may protect the gut and lower inflammation. Participants will take CC for a few months, and researchers will check their blood and stool for changes.

Research Team

Jean-Pierre Routy, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

Able to communicate adequately in either French or English.

3.2 Inclusion Criteria

Documented HIV-1 infection by Western Blot, Enzyme Immuno Assay (EIA) or viral load assay.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 2 capsules of Camu Camu daily for 12 weeks in addition to their ART

12 weeks

Assessments at baseline, during, and after treatment

Follow-up

Participants are monitored for changes in blood and stools for inflammation and microbe composition 8 weeks post-intake

8 weeks

Optional Sub-study

Assess changes of gut barrier by doing biopsies via colonoscopy

Treatment Details

Interventions

• Camu Camu Capsules

Participant Groups

Group I: Camu Camu Experimental Treatment 1 Intervention

Assessments will be done at baseline, during and after 12 weeks of Camu Camu intake.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Findings from Research

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

Many consumers mistakenly believe that complementary and alternative medicine (CAM) products are inherently safe, which raises concerns about potential interactions with pharmaceutical drugs, especially as their simultaneous use increases among Australians.

While adverse reactions to CAM products are generally low, there is a need for more systematic research to accurately define the risks associated with CAM, as current evidence suggests that most products do not pose a high risk but require further investigation to understand their impact on public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The other side of the coin: safety of complementary and alternative medicine. Myers, SP., Cheras, PA.[2004]

A review of 64,493 adverse reaction reports to the Swedish Medical Products Agency from 1987 to 2006 identified 778 reports related to complementary and alternative medicine (CAM) products, highlighting that these products can cause significant adverse reactions, including serious ones like pulmonary embolism and anaphylaxis.

The most commonly reported CAM substances associated with adverse reactions included Echinacea purpurea and Ginkgo biloba, indicating that while CAM products are popular, they carry risks that warrant further investigation and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. Jacobsson, I., Jönsson, AK., Gerdén, B., et al.[2009]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Risk-free complementary and alternative medicine?]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

The other side of the coin: safety of complementary and alternative medicine. [2004]

4. England pubmed.ncbi.nlm.nih.gov

Spontaneously reported adverse reactions in association with complementary and alternative medicine substances in Sweden. [2009]

5. United States pubmed.ncbi.nlm.nih.gov

Complementary and Alternative Medicines in the Management of Heart Failure: A Scientific Statement From the American Heart Association. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Outbreak of bovine clinical mastitis caused by Mycoplasma bovis in a North Italian herd. [2011]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A simplified PCR method for genotyping Mycoplasma mycoides subspecies mycoides small colony: the aetiologic agent of contagious bovine pleuropneumonia. [2018]

8. Germany pubmed.ncbi.nlm.nih.gov

Further evidence to justify reassignment of Mycoplasma mycoides subspecies mycoides Large Colony type to Mycoplasma mycoides subspecies capri. [2010]

9. Argentina pubmed.ncbi.nlm.nih.gov

[Identification of species of Mycoplasma and Ureaplasma diversum from Argentinian dairy herds]. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The pathogenicity and pathogenesis of Mycoplasma capricolum subsp. capripneumoniae (F38) in the caprine mammary gland. [2019]