Vaccines and Immunotherapies (VIT)
The purpose of this study is to determine if taking capsules containing Camu Camu (Camu CTM) in addition to antiretroviral therapy (ART) can reduce inflammation and immune activation. The study will determine the safety and tolerability of taking Camu CTM, evaluate the changes of inflammation in the blood and gut, assess the effect of Camu Camu on the types of bacteria in the gut and explore the effect of Camu Camu on the HIV reservoir (HIV virus hidden in cells) in the blood and the gut.
Camu CTM is a natural health product licensed for use in Canada, and the capsules contain an extract of the Camu Camu fruit found in the Amazonian rain forest.
When used consistently, antiretroviral therapy (ART) decreases HIV in the blood leading to improved health in people living with HIV. However, people living with HIV remain at higher risk of developing certain inflammatory-related health conditions including diabetes, fatty liver, cardiovascular disease, brain-related diseases, and cancer.
HIV keeps immune cells in an active or inflammatory state, partly due to the damage HIV does to the gut. In people living with HIV, the gut is leaky because the gut’s lining barrier is not strong enough to stop things like bad bacteria from crossing the gut lining into the blood and causing inflammation. Over time, a leaky gut can increase the risk of inflammatory-related health conditions. ART helps repair some of the damage caused by HIV; however, it cannot reduce the number of bacterial compounds crossing the gut barrier to the same level seen in people without HIV.
The gut contains tens of trillions of microorganisms, including at least 1000 different types of bacteria. Many bacteria are “good” and act as a barrier to prevent a leaky gut. When the types of bacteria in the gut is out of balance (there are less “good” bacteria), this can have a negative effect on gut health which can cause leaking and lead to inflammation. This has been shown to occur with HIV infection. Changing the types of bacteria in the gut so that there are more beneficial bacteria has been shown to partially reduce inflammation.
To try and restore the number of good bacteria, some people take prebiotics. Research in mice has shown that extracts of the fruit Camu Camu reduced the passage of bacteria from the gut to the blood and reduced the amount of chronic inflammation due to an increase in good bacteria. Camu Camu also reduced inflammation in human smokers. With these promising results, the current study aims to explore the possibility that Camu Camu can improve gut health and decrease inflammation in people living with HIV.
Study researchers will recruit 22 adults that have taken ART for over two years. All participants will be asked to take Camu CTM for 12 weeks. The study will take place over approximately 22 weeks and over the course of the study participants will visit the clinic six times to give blood and stool samples.
Participants at the Montreal clinic/site (word missing) that agree to take part in a sub-study will have a colonoscopy before and after taking 12 weeks Camu CTM so that researchers can assess changes in the gut mucosa (lining of the gut).
If you would like more information on this clinical study, please contact the Principal Investigator.