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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2022-07-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo three times daily for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months

Berberine

Berberine 500 mg three times daily for 6 months

Group Type EXPERIMENTAL

Berberine

Intervention Type DRUG

Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months

Interventions

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Berberine

Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months

Intervention Type DRUG

Placebo

Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No