Human Immunodeficiency Virus
Conditions
Keywords
HIV-positive individuals, Aerobic exercise training, Ginkgo biloba extract, Plasma lipid concentrations
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.
Interventions
DRUGAerobic 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
DRUGAerobic 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)
DRUGAerobic 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
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double-blind clinical trial with random allocation into three groups, all undergoing aerobic training. One group will receive ginkgo biloba extract, another will be administered atorvastatin, and a third will receive a placebo of calcined magnesia
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed