Clinical trial NCT06403787: Effect of Aerobic Training and Ginkgo Biloba on Lipids Levels in HIV-positive Patients Undergoing Antiretroviral Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Human Immunodeficiency Virus
Keywords: HIV-positive individuals
Aerobic exercise training
Ginkgo biloba extract
Plasma lipid concentrations
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of changes in serum lipid levels.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: University Center for Health Sciences
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Raul Soria Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: