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NCT Number: NCT06403787

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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Center for Health Sciences

Guadalajara, Jalisco, 44340, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic exercise + Ginkgo Biloba Extract

Drug

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)

Drug

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

Drug

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

Primary outcomes

  1. Comparison of changes in serum lipid levels.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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