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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06403787
• Other study ID #: CI-02922
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV Seropositivity
• Human Immunodeficiency Virus

Intervention

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
• 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)
• 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

Locations

Country	Name	City	State
Mexico	University Center for Health Sciences	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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