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

Hospital Civil de Guadalajara

Status and phase: Unknown; Phase 3

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

Treatments: Drug: Placebo; Drug: Berberine

Study type: Interventional

Funder types: Other

Identifiers

NCT04860063

MeSHIV-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo three times daily for 6 months

Treatment:

Drug: Placebo

Berberine

Experimental group

Description:

Berberine 500 mg three times daily for 6 months

Treatment:

Drug: Berberine