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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginkgo biloba group | Experimental | This group will assess the effects of aerobic exercise combined with ginkgo biloba extract |
|
| Placebo group | Placebo Comparator | Participants in this group will serve as a control to evaluate the effects of aerobic exercise when administered a placebo of calcined magnesia |
|
| Statins group | Active Comparator | In this group, the effects of aerobic exercise along with the administration of atorvastatin will be investigated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Raul Soria Rodriguez, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Center for Health Sciences | Guadalajara | Jalisco | 44340 | Mexico |
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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
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| 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 |
|
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C063170 | Ginkgo biloba extract |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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