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

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Civil de Guadalajara

Criteria

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