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

Phase 2

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Drug: Aerobic exercise + Ginkgo Biloba Extract; Drug: Aerobic exercise + Atorvastatin; Drug: Aerobic exercise + Calcined magnesia (placebo)

• Registration Number: NCT06403787
• Lead Sponsor: University of Guadalajara

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Last Update Submitted: 2024-05-03
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginkgo biloba group	Aerobic exercise + Ginkgo Biloba Extract	This group will assess the effects of aerobic exercise combined with ginkgo biloba extract
Statins group	Aerobic exercise + Atorvastatin	In this group, the effects of aerobic exercise along with the administration of atorvastatin will be investigated
Placebo group	Aerobic exercise + Calcined magnesia (placebo)	Participants in this group will serve as a control to evaluate the effects of aerobic exercise when administered a placebo of calcined magnesia

Primary Outcome Measures

Name	Time	Method
Comparison of changes in serum lipid levels.	12 weeks	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

Trial Locations

Locations (1)

University Center for Health Sciences; 🇲🇽 Guadalajara, Jalisco, Mexico