Human Immunodeficiency VirusPhase 2/3NCT06403787
Effect of Aerobic Training and Ginkgo Biloba on Lipids Levels in HIV-positive Patients Undergoing Antiretroviral Treatment
A Phase 2/3 study testing Aerobic exercise + Ginkgo Biloba Extract and Aerobic exercise + Atorvastatin in people with Human Immunodeficiency Virus, run by University of Guadalajara at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Aerobic exercise + Ginkgo Biloba Extract and Aerobic exercise + Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2022to 1 Apr 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Aerobic exercise + Ginkgo Biloba Extract, Aerobic exercise + Calcined magnesia (placebo), Aerobic exercise + Atorvastatin
- Keywords
- HIV-positive individuals, Aerobic exercise training, Ginkgo biloba extract, Plasma lipid concentrations
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise + Ginkgo Biloba ExtractDrug
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 + AtorvastatinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo biloba group | Experimental | This group will assess the effects of aerobic exercise combined with ginkgo biloba extract Receives: Drug: Aerobic exercise + 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 Receives: Drug: Aerobic exercise + Calcined magnesia (placebo) |
| Statins group | Active comparator | In this group, the effects of aerobic exercise along with the administration of atorvastatin will be investigated Receives: Drug: Aerobic exercise + Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 May 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raul Soria Rodriguez, PhD, University of Guadalajara
- Investigators
- Raul Soria Rodriguez, PhD, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403787
- Sponsor's protocol ID
- CI-02922
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06403787
- Acronym / sponsor ID
- CI-02922
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV-positive individuals, Aerobic exercise training, Ginkgo biloba extract, Plasma lipid concentrations
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Ginkgo biloba group | Experimental | Drug: Aerobic exercise + Ginkgo Biloba ExtractThis group will assess the effects of aerobic exercise combined with ginkgo biloba extract |
| Placebo group | Placebo comparator | Drug: Aerobic exercise + Calcined magnesia (placebo)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 | Drug: Aerobic exercise + AtorvastatinIn this group, the effects of aerobic exercise along with the administration of atorvastatin will be investigated |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise + Ginkgo Biloba Extract12 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 | Drug | Ginkgo biloba group |
| Aerobic 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) | Drug | Placebo group |
| Aerobic exercise + Atorvastatin12 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 | Drug | Statins group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul Soria Rodriguez, PhD principal investigator
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aerobic exercise + Ginkgo Biloba Extract and Aerobic exercise + Atorvastatin in people with Human Immunodeficiency Virus, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of changes in serum lipid levels. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.