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

NCT04860063 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospital Civil de Guadalajara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2022-04-30
Completion
2022-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860063 on ClinicalTrials.gov