Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.

Study Overview
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Brief Summary
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With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance. Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.

Official Title
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Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.

Conditions
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Metabolic Syndrome, HIV-1-infection, Glucose Intolerance, Dyslipidemias, Lipodystrophy, Lipoatrophy

Intervention / Treatment
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* Drug: Berberine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 60 years Documented HIV-1 infection Stable antiretroviral therapy at least 6 months before enrollment Viral suppression Metabolic syndrome , defined by Adult Treatment Panel-III criteria No previously known kidney or liver disease Signed informed consent Exclusion Criteria: People younger than 18 years and older than 60 years Prior atherosclerotic cardiovascular disease Diabetes mellitus type 1 or 2 Previous use of glucose and/or lipid modifying medications Pregnancy Withdrawal of informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo three times daily for 6 months | Drug: Placebo<br>* Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months<br>|
| Experimental: Berberine<br>Berberine 500 mg three times daily for 6 months | Drug: Berberine<br>* Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months | 24 weeks within randomization | 
| Change from baseline lipid profile at 6 months | Measurement of total cholesterol, HDL, LDL, triglycerides. | At the beginning and 24 weeks within randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline weight | Weight gain or loss measure by kilograms | At the beginning and 24 weeks within randomization | 
| Inflammatory profile | Level of pro-inflammatory cytokines | At the beginning and 24 weeks within randomization |