Effect of Aerobic Training and Ginkgo Biloba on Lipids Levels in HIV-positive Patients Undergoing Antiretroviral Treatment

Last updated: May 3, 2024
Sponsor: University of Guadalajara
Overall Status: Completed

Phase

2/3

Condition

Hiv Infections

Hiv

Hiv/aids

Treatment

Aerobic exercise + Ginkgo Biloba Extract

Aerobic exercise + Atorvastatin

Aerobic exercise + Calcined magnesia (placebo)

Clinical Study ID

NCT06403787
CI-02922
  • Ages 18-60
  • All Genders

Study Summary

The administration of antiretroviral drugs (ART) has significantly prolonged the life expectancy of people living with human immunodeficiency virus (HIV) and delayed the progression towards Acquired Immune Deficiency Syndrome (AIDS). However, this has led to the emergence of other conditions, such as dyslipidemia, among individuals undergoing ART. Dyslipidemia is commonly managed with statin therapy, which has not been reported to have pharmacological interactions with ART. Additionally, ginkgo biloba extract (GBS) has been observed to improve blood lipid concentrations, and aerobic exercise training (EXA) interventions have shown positive modifications in these values.

Given this context, the present study aims to investigate the potential positive effects of an aerobic training program and the consumption of ginkgo biloba extract on plasma lipid concentrations in HIV-positive individuals. The study seeks to provide insights into novel strategies for managing dyslipidemia in this population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 18 to 60 years
  • Diagnosis of HIV-1 infection
  • Receiving antiretroviral therapy with a triple regimen (Biktarvy treatment)
  • Undetectable viral load (< 20 copies/mL) for the past 6 months CD4+ level > 200cells/μL
  • Diagnosis of mixed dyslipidemia in the last three months, indicated by:
  • Total cholesterol ≥ 200 mg/dL
  • HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women
  • LDL cholesterol > 100 mg/dL
  • Triglycerides ≥ 150 mg/dL
  • Possession of a mobile device or computer with internet access and necessary platforms
  • Willingness to participate voluntarily in the study and provide written consent

Exclusion

Exclusion Criteria:

  • Individuals who develop hypersensitivity or allergy to ginkgo biloba extract
  • Failure to attend at least 80% of the physical exercise sessions (equivalent tomissing more than 12 sessions)
  • Lack of adherence to pharmacological treatment
  • Participant's decision to discontinue the intervention

Study Design

Total Participants: 28
Treatment Group(s): 3
Primary Treatment: Aerobic exercise + Ginkgo Biloba Extract
Phase: 2/3
Study Start date:
May 01, 2022
Estimated Completion Date:
April 01, 2024

Connect with a study center

  • University Center for Health Sciences

    Guadalajara, Jalisco 44340
    Mexico

    Site Not Available

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