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

Phase 3

• Conditions: Dyslipidemias; Lipodystrophy; Metabolic Syndrome; Glucose Intolerance; HIV-1-infection; Lipoatrophy
• Interventions: Drug: Placebo; Drug: Berberine

• Registration Number: NCT04860063
• Lead Sponsor: Hospital Civil de Guadalajara

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04
• Study First Submitted: 2021-04-17
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26
• Primary Completion: 2022-04
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo three times daily for 6 months
Berberine	Berberine	Berberine 500 mg three times daily for 6 months

Primary Outcome Measures

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

Secondary Outcome Measures

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