An interventional study of Exercise in HIV/AIDS, sponsored by Instituto Nacional de Cardiologia de Laranjeiras. Completed at 1 site in Brazil. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Instituto Nacional de Cardiologia de Laranjeiras · Not applicable, Interventional, and Basic science
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Among 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil — 7 open to participants now, 10 under way, 4 of them phase 3. Acquired Immunodeficiency Syndrome · Brazil.
Among the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil, this one is the 31st largest by enrollment of the 42 interventional ones that give a count, is one of 4 that started in 2017, is one of 11 with no phase, and was the 37th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →7 of the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil are open now. Recruiting first, the newest first:
Federal University of São Paulo · Sites in Brazil
Ages 18–60
Federal University of São Paulo · Sites in Brazil
Ages 18–65
Hospital Alemão Oswaldo Cruz · Sites in Brazil
Ages 18+
Federal University of Health Science of Porto Alegre · Sites in Brazil
Ages 18+
Code Pharma · Sites in Brazil
Ages 18+
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 20 Years to 65 Years · all sexes · no healthy volunteers.
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57 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 50 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 132 across the 42 interventional studies, 923 across the 14 observational. Of the 40 that completed or were terminated, 16 (40%) have results posted.
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24 of 57 have an industry lead sponsor. The 10 most frequent:
Instituto Nacional de Cardiologia de Laranjeiras is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Instituto Nacional de Cardiologia de Laranjeiras has 1 study filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
5 of the studies in Acquired Immunodeficiency Syndrome with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT07118683Hospital Alemão Oswaldo CruzBRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS | 2026-11 |
| NCT06805656Federal University of São PauloMulti Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals | 2027-03-01 |
| NCT06497504GlaxoSmithKlineStudy of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) | 2027-04-22 |
| NCT07903441Federal University of São PauloMultiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment | 2027-07-31 |
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Among the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Introduction: It is well known that the infection caused by the Human Immunodeficiency Virus (HIV) is associated to a higher cardiovascular event risk. On the other hand, it is clear that the aerobic exercise training induces improvements in autonomic control and vascular function, through increases in vasodilator agents and blood vessels number. However, the investigators could not find previous works that studied the microvascular function in response to exercise training in HIV patients.
Objectives: To study the impact of aerobic exercise training in endothelial function of HIV patients. In addition, the investigators will verify the association of the physical fitness to the nitric oxide bioavailability, angiogenesis and lipid profile in HIV patients.
Methods: The study subjects will be composed by HIV patients, that will be randomly divided in two different groups: exercised and sedentary. The subjects will be tested before and after training in regards to endothelial function, nitric oxide bioavailability, physical fitness and lipid profile, through flowmetry, colorimetric essays, maximal cardiopulmonary exercise test, and biochemical tests; respectively. The exercise training will be performed in a treadmill for 12 weeks, 3 times a week, 40 minutes each section.
Expected Results: The investigators expect to achieve markers that will help in understanding the interaction of HIV with several factors that contribute to an increased endothelial function after exercise training.
HIV-infection triggers a massive oxygen reactive species production, increasing oxidative stress and vascular complications. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among HIV-infected patients (HIVP), exercise-related effects upon macro-and-microvascular endothelial function and oxidative stress in HIVP have not been previously reported.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients assigned to this arm shall not perform regular exercise training.
Patients assigned to this arm will be enrolled in exercise training program.
Behavioral: Exercise
A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).
Skin microvascular blood flow
Microvascular reactivity will be evaluated by laser speckle contrast imaging with laser wavelength of 785 nm in combination with iontophoresis of acetylcholine (ACh) and sodium nitroprusside (SNP) for noninvasive and continuous measurements of cutaneous microvascular flow changes in the forearm.
Time frame: Baseline and 3 months
Peak Oxygen consumption
Measured at a maximal graded exercise test.
Time frame: Baseline and 3 months
Nitrite/nitrate
Colorimetric assay kit
Time frame: Baseline and 3 months
Body fat
Dual-energy X-ray absorptiometry.
Time frame: Baseline and 3 months
Forearm macrovascular blood flow
Forearm macrovascular blood flow will be evaluated by venous occlusion plethysmography.
Time frame: Baseline and 3 months
Capillary density
Capillary density will be evaluated by high-resolution intra-vital color microscopy.
Time frame: Baseline and 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Dec 2022, 61 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 61 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Instituto Nacional de Cardiologia de Laranjeiras