NCT04860063

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-04-01
• Completion: 2022-07-01
• First posted: 2021-04-26
• Last updated: 2021-04-26