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

Effect of Implementing an Aerobic Training Program and Administering Ginkgo Biloba Extract on Plasma Concentrations of LDL and HDL in HIV Positive Patients Undergoing Antiretroviral Treatment at the HIV Unit of Hospital Civil Fray Antonio Alcalde

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Aerobic exercise + Ginkgo Biloba Extract; Drug: Aerobic exercise + Calcined magnesia (placebo); Drug: Aerobic exercise + Atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • University Center for Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 > 200 cells/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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ginkgo biloba group; This group will assess the effects of aerobic exercise combined with ginkgo biloba extract	Drug: Aerobic exercise + Ginkgo Biloba Extract; 12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with 240 mg of LIFE EXTENSION® brand ginkgo biloba extract in 120 mg tablets
Placebo Comparator: Placebo group; Participants in this group will serve as a control to evaluate the effects of aerobic exercise when administered a placebo of calcined magnesia	Drug: Aerobic exercise + Calcined magnesia (placebo); 12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with calcined magnesia (homogenized to the same weight of ginkgo biloba)
Active Comparator: Statins group; In this group, the effects of aerobic exercise along with the administration of atorvastatin will be investigated	Drug: Aerobic exercise + Atorvastatin; 12 weeks of intervention for the participants, divided into 3 stages implementing an exercise adaptation period. The adaptation period will span the first 4 weeks of the intervention, during which participants will be brought to an intensity between 50% and 60% of their maximum heart rate (HRmax). From week 5 to 8, the HRmax range will be increased from 60% to 70%, and during the last 4 weeks, it will be maintained at 70% of HRmax combined with 20 mg of atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of changes in serum lipid levels.	Levels of Total Cholesterol (mg/dL), HDL (High-Density Lipoprotein) (mg/dL), LDL (Low-Density Lipoprotein) (mg/dL), VLDL (Very Low-Density Lipoprotein) (mg/dL) and, Triglycerides (mg/dL) will be assessed	12 weeks

Collaborators and Investigators

• Sponsor: University of Guadalajara
• Investigators: Principal Investigator: Raul Soria Rodriguez, PhD, University of Guadalajara

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Ginkgo biloba extract; Aerobic exercise training; HIV-positive individuals; Plasma lipid concentrations
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; HIV Seropositivity; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Gastrointestinal Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Antacids; Atorvastatin; Magnesium Oxide
• Other Study ID Numbers: CI-02922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No