Camu Camu for 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Camu Camu, a fruit extract, to determine if it can reduce inflammation in people living with HIV who are already on antiretroviral therapy (ART). Researchers believe Camu Camu might boost beneficial gut bacteria, lower inflammation, and protect against other health issues like heart disease and liver problems. Participants will take Camu Camu capsules for 12 weeks, and the team will monitor their gut health and inflammation levels. Those who have had HIV for at least two years and are on a stable ART regimen might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

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 there any evidence suggesting that Camu Camu Capsules are likely to be safe for humans?

Research shows that Camu Camu, a fruit from the Amazon, has been used for health issues like colds and fatigue. However, reliable information about its safety or side effects in humans remains limited. A safety report indicated that Camu Camu is safe to eat and does not cause harm when ingested. Some studies suggest that the fruit extract might be safe and could help reduce allergic reactions.

While Camu Camu is available in health stores and has been studied for its benefits, most research involves animals or general uses, not specific treatments like in this trial. This trial is in an early stage, so researchers are closely monitoring its safety for humans. Although some data suggest it is generally well-tolerated, more research is needed to fully understand the safety of Camu Camu capsules in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional antiretroviral therapies for HIV, which focus on suppressing the virus, Camu Camu capsules introduce a natural, plant-based approach. Camu Camu is packed with vitamin C and antioxidants, potentially offering additional health benefits like boosting the immune system and reducing inflammation. Researchers are excited because this treatment might complement existing therapies by enhancing overall health and wellness in people living with HIV.

What evidence suggests that Camu Camu Capsules might be an effective treatment for inflammation in persons living with HIV?

Research has shown that Camu Camu, a fruit from the Amazon, is rich in vitamin C and possesses strong properties that combat damage and reduce swelling. One study found that Camu Camu reduced signs of cell damage and inflammation more effectively than regular vitamin C tablets. Another study discovered that an extract from Camu Camu helped protect mice from weight gain, reduced harmful gut bacteria, and lowered inflammation. This was linked to an increase in a beneficial gut bacteria called Akkermansia muciniphila, which supports gut health. This trial will evaluate the effects of Camu Camu Capsules on inflammation in people with HIV who are on antiretroviral therapy. ^{6 7 8 9 10}

Who Is on the Research Team?

Jean-Pierre Routy, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Camu Camu Capsules

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4296744/

Antioxidant and Associated Capacities of Camu Camu ... The amount of vitamin C per 100 mL of camu camu was 52.5 mg. DPPH assay showed an antioxidant potential of the fruit. No camu camu concentration tested exerted ...

2. pubs.acs.org pubs.acs.org/doi/10.1021/acsomega.2c07245

An Amazonian Fruit with Biofunctional Properties–A Review To our knowledge, clinical trials with camu camu are being developed to prevent hypertension and diabetes, so the expected results would provide ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0963996923013686

Characterization and bioaccessibility assessment of ... The bioaccessibility studies in gastric and intestinal phases showed better recovery percentages of bioactive compounds in camu-camu powders (up to 60.8 %) and ...

4. pharmacist.com pharmacist.com/Blogs/CEO-Blog/camu-camu-a-vitamin-c-powerhouse

Camu camu: A vitamin C powerhouse Results showed reduced oxidative stress and C-reactive protein levels, while the placebo group, who took a vitamin C tablet, saw no changes.

5. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087%2808%2900150-0/fulltext

Tropical fruit camu-camu (Myrciaria dubia) has anti- ... Our results suggest that camu-camu juice may have powerful anti-oxidative and anti-inflammatory properties, compared to vitamin C tablets containing equivalent ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1243/camu-camu

Camu Camu - Uses, Side Effects, and More Camu camu is an acidic, sour fruit from the Amazon, used for colds and fatigue, but with no reliable safety or side effect information. Avoid during pregnancy/ ...

7. organiccrops.net organiccrops.net/bin/OC_MSDS_CamuCamu-Powder_1802_EN.pdf

MATERIAL SAFETY DATA SHEET CAMU CAMU POWDER SKIN: Wash with soap and water. Get medical attention if irritation persists. INGESTION: Food grade, no hazard. INHALATION:.

8. ams.usda.gov ams.usda.gov/sites/default/files/media/Camu%20Camu%20Extract%20Petition.pdf

Camu Camu Extract Petition.pdf Safety information about the substance including a Material Safety Data Sheet (MSDS) ... Camu-camu (Myrciaria dubia), a native fruit of the Amazon ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8773304/

Anti-Allergic Effects of Myrciaria dubia (Camu-Camu) Fruit ... This indicates that camu-camu fruit extract is safe ... These data indicate that camu-camu fruit extract decreased cell degranulation and ...

10. rxlist.com rxlist.com/supplements/camu_camu.htm

Camu Camu: Health Benefits, Side Effects, Uses, Dose & ... Camu camu is used for viral infections including herpes, cold sores, shingles, and the common cold. It is also used for eye conditions including cataracts and ...