Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-06 @ 7:47 PM
Study NCT ID:
NCT03392805
Status:
UNKNOWN
Last Update Posted:
2018-01-08
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta between Rockport Walking Test value at T0 and T6', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Delta between CD4+CD38+ value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between CD8+CD38+ value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between CD4+HLADR+ value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between CD8+HLADR+ value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between TNF-α value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between IL-6 value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between adiponectin value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between resistinat T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between leptin value at T0 and T6', 'timeFrame': '6 months'}, {'measure': 'Delta between maximal Oxygen uptake value at T0 and T6', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection']}, 'descriptionModule': {'briefSummary': 'exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. The primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.', 'detailedDescription': 'Many studies document that exercise and physical activity can have an anti-inflammatory effect, while there is evidence that a sedentary lifestyle could be the basis for the development of systemic inflammation and increased cardiovascular risk. This occurs because a sedentary lifestyle leads to the accumulation of visceral fat, and this is accompanied by an increase in adipokine release and infiltration of adipose tissue by the pro-inflammatory immune cells. Furthermore, the imbalance between immune processes and metabolic processes is associated with the development of insulin resistance, atherosclerosis and neurodegeneration.\n\nThe primary objective is to assess whether regular physical activity is able to induce a decrease in systemic immune-activation in HIV positive patients.\n\nTo evaluate this hypothesis, the following parameters will be analyzed: evaluation of immune-activation levels, of metabolic parameters, of cardiac function, of immuno-virological set-up, of dietary intake and of physical performance indices in HIV-positive patients with a sedentary lifestyle; these data will be compared with the values measured in the same HIV positive population with a sedentary lifestyle after three months of regular physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18-60 years\n2. Patients who have signed informed consent\n3. HIV positive patients\n4. Patients who have performed a sports medical examination with ECG and are suitable for non-competitive physical activity.\n\nExclusion Criteria:\n\n1. Anemia, pregnancy or any other contraindication to blood sampling and sports activity\n2. Patients suffering from cardiomyopathies and ischemic heart disease'}, 'identificationModule': {'nctId': 'NCT03392805', 'acronym': 'PRIMO', 'briefTitle': 'Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Infectious Diseases and Movement Program: Study of the Effects of Physical Activity on HIV Infection', 'orgStudyIdInfo': {'id': 'DPHID-UniRoma04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sedentary life style', 'interventionNames': ['Behavioral: physical activity']}, {'type': 'NO_INTERVENTION', 'label': 'physically active life style'}], 'interventions': [{'name': 'physical activity', 'type': 'BEHAVIORAL', 'description': 'beginning of regular physical activity under the supervision of a coach', 'armGroupLabels': ['sedentary life style']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Gabriella d'Ettorre, MD PhD", 'role': 'CONTACT', 'email': 'gabriella.dettorre@uniroma1.it', 'phone': '+39-06-49970324'}, {'name': 'Giancarlo Ceccarelli, MD PhD MSc', 'role': 'CONTACT', 'email': 'gabriella.dettorre@uniroma1.it', 'phone': '+39-06-49970900'}, {'name': 'Giancarlo Ceccarelli, MD PhD MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': "Gabriella d'Ettorre, MD PhD", 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vincenzo Vullo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Public Health and Infectious Diseases, University of Rome "La Sapienza"', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': "Gabriella d'Ettorre, MD PhD", 'role': 'CONTACT', 'email': 'gabriella.dettorre@uniroma1.it', 'phone': '+39-06-49970324'}, {'name': 'Giancarlo Ceccarelli, MD PhD MSc', 'role': 'CONTACT', 'email': 'giancarlo.ceccarelli@uniroma1.it', 'phone': '+39-06-49970900'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Reasercher co-PI', 'investigatorFullName': 'Giancarlo Ceccarelli', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}