NCT06403787CompletedPhase 2/3
Effect of Aerobic Training and Ginkgo Biloba on Lipids Levels in HIV-positive Patients Undergoing Antiretroviral Treatment
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
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 3 May 2024
- Start date
- May 2022
- Primary completion date
- Apr 2023
- Lead sponsor
- University of Guadalajara
- Diseases
- HIV
- NCT number
- NCT06403787
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 28
- From May 2022 to the primary completion date, Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Lack of adherence to pharmacological treatment
- Participant's decision to discontinue the intervention
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Center for Health Sciences Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.