Impact of Probiotics in HIV-positive Patients With Neurocognitive Disorders

  • STATUS
    Recruiting
  • End date
    Apr 15, 2022
  • participants needed
    50
  • sponsor
    Centre Hospitalier Universitaire de Nice
Updated on 2 August 2021
imbalance
immunodeficiency
HIV Infection
antiretroviral agents
antiretroviral therapy
cognitive impairment
inflammatory response
dementia
mild cognitive impairment
HIV Vaccine
dysbiosis
intestinal dysbiosis

Summary

The prevalence of HIV-associated neurocognitive disorders (Human Immunodeficiency Virus) remains high during the era of effective triple therapy. The main clinical phenotypes of cognitive impairment are currently represented by asymptomatic neurocognitive neurocognitive impairment (ANI) and mild neurocognitive disorders (MND). In contrast, HIV-associated dementia has almost disappeared.

Among the hypotheses to explain the persistence of such a high prevalence is the persistent activation of the immune system despite virological success. This chronic immune activation is believed to be responsible for an inflammatory response and therefore for accelerated cell aging. Several organ complications in HIV-positive patients have been associated with high markers of immune activation.

Among the causes of chronic immune activation in virologically controlled patients, an imbalance in the intestinal flora is suspected. In fact, shortly after HIV infection, the virus causes significant apoptosis of intestinal lymphocytes, responsible for a loss of integrity of the intestinal barrier and an imbalance of flora, defined as "dysbiosis".

Loss of epithelial integrity and intestinal dysbiosis are suspected of causing systemic passage of bacterial fragments, of which lypopolisaccharide is best known, resulting in chronic activation of the immune system. Several studies suggest a link between digestive bacterial translocation and HIV-related neurocognitive disorders. An improvement in intestinal dysbiosis could therefore contribute to reducing immune activation and the severity of cognitive impairment. A recent study showed that probiotics can reduce levels of neopterin, a marker of monocytic activation, in the cerebrospinal fluid of HIV-positive patients without neurological symptoms.

Our objective is to evaluate the impact of probiotic supplementation on immune activation and cognitive performance in virologically controlled HIV-positive patients with a diagnosis of ANI or MND. The potential improvement of cognition through probiotic treatment could therefore improve their quality of life at a lower cost than a drug and without the risk of serious side effects.

Details
Condition HIV, HIV positive, HIV infection, AIDS Vaccines, Neurocognitive Disorders, Neurocognitive Disorder, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment Vivomixx
Clinical Study IdentifierNCT04175223
SponsorCentre Hospitalier Universitaire de Nice
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who have signed informed consent
Patients infected with HIV-1
Patients with undetectable viral load and stable antiretroviral therapy for at least 6 months
Patients with HIV-related neurocognitive disorders of the ANI or MND type, to be confirmed by neuropsychological assessment at inclusion
Outpatient patients, over 18 years of age
Patients with social security coverage

Exclusion Criteria

Patients infected with HIV-2
Patients who have not been on stable antiretroviral therapy and have been virologically successful for at least 6 months
Patients who have been treated during the primary infection phase, taking into account the potential risks of impact on intestinal lymphocyte apoptosis and therefore on the microbiota
Patients who do not have HIV-related neurocognitive disorders such as ANI or MND
Patients refusing to participate in the study
Patients consuming probiotics at inclusion
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