Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT07144293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving Physical Ability and Cellular Senescence Elimination in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}, {'id': 'D011794', 'term': 'Quercetin'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Grade 2 or higher adverse events (AEs) after initiation of study treatment.', 'timeFrame': '24 weeks'}, {'measure': 'Occurrence of premature treatment discontinuations.', 'timeFrame': '24 weeks'}, {'measure': 'Absolute change in gait speed on 4-meter walk.', 'timeFrame': 'From Week 0 to Week 12'}], 'secondaryOutcomes': [{'measure': 'Absolute change in time to complete 5 chair stands.', 'timeFrame': 'From Week 0 to Week 12'}, {'measure': 'Absolute change in Short Performance Physical Battery (SPPB) Total Balance Test score.', 'timeFrame': 'From Week 0 to Week 12', 'description': 'The Short Performance Physical Battery (SPPB) Total Balance Test scores range from a minimum of 0 to a maximum of 4. Higher scores indicate better balance performance.'}, {'measure': 'Absolute change in the SPPB score.', 'timeFrame': 'From Week 0 to Week 12', 'description': 'The SPPB scores range from a minimum of 0 to a maximum of 12. Higher scores indicate better physical performance.'}, {'measure': 'Absolute change in 4-meter gait speed.', 'timeFrame': 'From Week 0 to Week 24'}, {'measure': 'Absolute change in SPPB total balance test score.', 'timeFrame': 'From Week 0 to Week 24', 'description': 'The SPPB Total Balance Test scores range from a minimum of 0 to a maximum of 4. Higher scores indicate better balance performance.'}, {'measure': 'Absolute change in SPPB score.', 'timeFrame': 'From Week 0 to Week 24', 'description': 'The SPPB scores range from a minimum of 0 to a maximum of 12. Higher scores indicate better physical performance.'}, {'measure': 'Absolute change in timed chair stands.', 'timeFrame': 'From Week 0 to Week 24'}, {'measure': 'Absolute change in plasma senescence-associated secretory phenotype (SASP) biomarkers.', 'timeFrame': 'From Week 0 to Weeks 12 and 24'}, {'measure': 'Absolute change in serum SASP biomarkers.', 'timeFrame': 'From Week 0 to Weeks 12 and 24'}, {'measure': 'Absolute change in cognitive function on the AIDS Clinical Trials Group (ACTG) Neuropsychology Battery "Neuropsychological Battery" section', 'timeFrame': 'From Week 0 to Weeks 12 and 24', 'description': 'Higher scores indicate better cognitive performance.'}, {'measure': 'Absolute change in symptoms of anxiety and depression using the Patient Health Questionnaire-9 (PHQ-9) assessments', 'timeFrame': 'From Week 0 to Weeks 12 and 24', 'description': 'The PHQ-9 scores range from a minimum of 0 to a maximum of 27. Lower scores indicate better mental health, while higher scores indicate more severe depression.'}, {'measure': 'Absolute change in Veterans Aging Cohort Study (VACS) Index 2.0.', 'timeFrame': 'From Week 0 to Weeks 12 and 24', 'description': 'The VACS Index 2.0 scores range from a minimum of 0 to a maximum of 164. Higher scores indicate a higher risk of mortality and worse health outcomes.'}, {'measure': 'Absolute change in participant-reported Quality of Life (QoL) on the Patient-Reported Outcomes Measurement Information System (PROMIS) QoL measure', 'timeFrame': 'From Week 0 to Weeks 12 and 24', 'description': 'The PROMIS QoL measure have no fixed minimum score, but scores can theoretically go as low as 0 and no fixed maximum score, but scores can theoretically go as high as 100. Higher scores indicate better quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'Prefrail', 'Physical Function', 'Aging', 'Senescence', 'Senolytic therapy'], 'conditions': ['HIV', 'Frailty', 'Prefrail', 'Aging Problems']}, 'descriptionModule': {'briefSummary': 'This clinical trial is a Phase II study designed to test the safety and effectiveness of a combination of dasatinib and quercetin (D+Q) in improving physical function for people with HIV who are frail or prefrail. The study will involve 80 participants, all aged 50 or older, who have been living with HIV for at least 10 years determined to meet criteria for diagnosis of frail or prefrail and are currently on a stable antiretroviral therapy with viral suppression.\n\nParticipants will be randomly assigned to one of two groups: one group will receive the D+Q treatment, and the other will receive a placebo. The treatment will be given in six cycles over 12 weeks, with participants taking the medication for two days followed by 12 days without treatment. After the 12-week treatment period, participants will be monitored for another 12 weeks to assess the long-term effects.\n\nThe study aims to determine if D+Q can improve physical function and other health outcomes in this population. Randomization will be stratified by sex and age to ensure balanced groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must be an older person with confirmed diagnosis of HIV-1, defined as ≥ 50 years at study entry.\n2. Must have been diagnosed with HIV at least 10 years ago, as confirmed by medical records or self-report.\n3. Must be on a stable effective combination antiretroviral therapy (ART) regimen, with no changes in the regimen within 12 weeks before joining the study with 2 or more consecutive HIV-RNA levels \\< 50 copies/mL within 48 weeks prior to study entry.\n4. Must meet one or more Fried Frailty Phenotype criteria w/in 60 days prior to entry.\n5. Must have eGFR \\> 30 using CKD-EPI per 2021 calculation equation.\n\nExclusion Criteria:\n\n1. Have used quercetin or dasatinib before.\n2. Need to take medications that affect CYP3A4 or interact with dasatinib (e.g., certain HIV medications).\n3. Have an active cancer (except non-melanoma skin cancer).\n4. Have active liver disease with a Child Pugh score greater than 6, or other significant liver problems.\n5. Are on dialysis or have had a kidney transplant.\n6. Have had a heart attack, angina, stroke, or mini-stroke in the last 6 months.\n7. Have a known history of pulmonary arterial hypertension or other respiratory disease requiring supplemental oxygen within 60 days before joining the study.\n8. Have uncontrolled diabetes with an HgbA1c level greater than 8% within 60 days before joining the study.\n9. Have substance use that might interfere with study participation, as determined by the site investigator.\n10. Have had a significant illness within 60 days before joining the study.'}, 'identificationModule': {'nctId': 'NCT07144293', 'acronym': 'IPACE-HIV', 'briefTitle': 'Improving Physical Ability and Cellular Senescence Elimination in HIV', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Improving Physical Ability and Cellular Senescence Elimination in HIV', 'orgStudyIdInfo': {'id': 'A5426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: D+Q', 'interventionNames': ['Drug: Dasatinib', 'Drug: Quercetin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B: Placebo', 'interventionNames': ['Other: Placebo - Dasatinib', 'Other: Placebo - Quercetin']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'description': 'Dasatinib will be administered as one 100 mg capsule.', 'armGroupLabels': ['Arm A: D+Q']}, {'name': 'Quercetin', 'type': 'DRUG', 'description': 'Quercetin will be administered as five 250 mg capsules.', 'armGroupLabels': ['Arm A: D+Q']}, {'name': 'Placebo - Dasatinib', 'type': 'OTHER', 'description': 'Matching Placebo for Dasatinib will be administered as one 100 mg capsule.', 'armGroupLabels': ['Arm B: Placebo']}, {'name': 'Placebo - Quercetin', 'type': 'OTHER', 'description': 'Matching Placebo for Quercetin will be administered as five 250 mg capsules.', 'armGroupLabels': ['Arm B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35222', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'Heather Logan, ANP', 'role': 'CONTACT', 'email': 'heatherlogan@uabmc.edu', 'phone': '205-873-8686'}], 'facility': 'Alabama CRS (Site ID: 31788)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90035-4709', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Aleen Khodabakhshian', 'role': 'CONTACT', 'email': 'akhodabakhshian@mednet.ucla.edu', 'phone': '310-557-2273', 'phoneExt': '20891'}], 'facility': 'University of California, Los Angeles CARE Center CRS (Site ID: 601)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Steven Hendrickx, R.N.', 'role': 'CONTACT', 'email': 'smhendrickx@health.ucsd.edu', 'phone': '619-543-6968'}], 'facility': 'UCSD Antiviral Research Center CRS (Site ID: 701)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'John Dwyer, RN', 'role': 'CONTACT', 'email': 'Jay.Dwyer@ucsf.edu', 'phone': '415-476-4082', 'phoneExt': '353'}], 'facility': 'University of California, San Francisco HIV/AIDS CRS (Site ID: 801)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Mario Guerrero', 'role': 'CONTACT', 'email': 'mguerrero@lundquist.org', 'phone': '424-201-3000', 'phoneExt': '7318'}], 'facility': 'Harbor University of California Los Angeles Center CRS (Site ID: 603)', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'contacts': [{'name': 'Nicola Haakonsen, BS', 'role': 'CONTACT', 'email': 'Nicola.haakonsen@cuanschutz.edu', 'phone': '303-724-0708'}], 'facility': 'University of Colorado Hospital CRS (Site ID: 6101)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'contacts': [{'name': 'Avery Wimpelberg, BA, CCRC', 'role': 'CONTACT', 'email': 'AWimpelberg@whitman-walker.org', 'phone': '202-797-3589'}], 'facility': 'Whitman-Walker Institute, Inc. CRS (Site ID: 31791)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30308-2012', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Ericka Patrick, MSN', 'role': 'CONTACT', 'email': 'erpatri@emory.edu', 'phone': '404-616-6313'}], 'facility': 'The Ponce de Leon Center CRS (Site ID: 5802)', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Sherryl Wolfe, BSN, RN, CCRC', 'role': 'CONTACT', 'email': 's-wolfe@northwestern.edu', 'phone': '1-312-695-4997'}], 'facility': 'Northwestern University CRS (Site ID: 2701)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Amy Sbrolla, RN, BSN, ACRN', 'role': 'CONTACT', 'email': 'asbrolla@mgh.harvard.edu', 'phone': '1-617-726-5598'}], 'facility': 'Massachusetts General Hospital CRS (MGH CRS) (Site ID: 101)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Hannah Jordan', 'role': 'CONTACT', 'email': 'hcjordan@bwh.harvard.edu', 'phone': '617-732-4785'}], 'facility': "Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS (Site ID: 107)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110-1010', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'contacts': [{'name': 'Michael K Klebert', 'role': 'CONTACT', 'email': 'mklebert@wustl.edu', 'phone': '314-747-1098'}], 'facility': 'Washington University Therapeutics (WT) CRS (Site ID: 2101)', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'contacts': [{'name': 'Christie Costanza', 'role': 'CONTACT', 'email': 'costancl@njms.rutgers.edu', 'phone': '973-972-9069'}], 'facility': 'New Jersey Medical School Clinical Research Center CRS (Site ID: 31786)', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Rebecca Fry, MSN, FNP', 'role': 'CONTACT', 'email': 'ref2007@med.cornell.edu', 'phone': '212-746-7198'}], 'facility': 'Weill Cornell Chelsea CRS (Site ID: 7804)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Anyelina Cantos', 'role': 'CONTACT', 'email': 'ac4314@cumc.columbia.edu', 'phone': '212-305-2201'}], 'facility': 'Columbia Physicians & Surgeons (P&S) CRS (Site ID: 30329)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Keisha Ballentine-Cargill', 'role': 'CONTACT', 'email': 'keb4006@med.cornell.edu', 'phone': '212-746-4177'}], 'facility': 'Weill Cornell Uptown CRS (Site ID: 7803)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Susan Hulse', 'role': 'CONTACT', 'email': 'susan_hulse@urmc.rochester.edu', 'phone': '585-275-0529'}], 'facility': 'University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site ID: 31787)', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Erin Hoffman', 'role': 'CONTACT', 'email': 'erin_hoffman@med.unc.edu', 'phone': '919-843-0720'}], 'facility': 'Chapel Hill CRS (Site ID: 3201)', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'contacts': [{'name': 'Kelly Phillips', 'role': 'CONTACT', 'email': 'kelly.phillips@conehealth.com', 'phone': '336-832-7297'}], 'facility': 'Greensboro CRS (Site ID: 3203)', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45267-0405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Michelle Saemann', 'role': 'CONTACT', 'email': 'saemanmd@ucmail.uc.edu', 'phone': '513-584-2245'}], 'facility': 'Cincinnati CRS (Site ID: 2401)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Julie Pasternak, RN', 'role': 'CONTACT', 'email': 'pasternak.julie@clevelandactu.org', 'phone': '216-844-2738'}], 'facility': 'Case CRS (Site ID: 2501)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'contacts': [{'name': 'Lindsay Summers, MPH', 'role': 'CONTACT', 'email': 'Lindsay.Summers@osumc.edu', 'phone': '614-293-8529'}], 'facility': 'Ohio State University CRS (Site ID: 2301)', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Jason Kirschner', 'role': 'CONTACT', 'email': 'Jason.Kirschner@pennmedicine.upenn.edu', 'phone': '347-674-1545'}], 'facility': 'Penn Therapeutics CRS (Site ID: 6201)', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Stacey M. Edick, BA, MPAS', 'role': 'CONTACT', 'email': 'edicksm2@upmc.edu', 'phone': '412-383-1748'}], 'facility': 'University of Pittsburgh CRS (Site ID: 1001)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'contacts': [{'name': 'Beverly O. Woodward, MSN, RN', 'role': 'CONTACT', 'email': 'beverly.o.woodward@vumc.org', 'phone': '615-936-8516'}], 'facility': 'Vanderbilt Therapeutics (VT) CRS (Site ID: 3652)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Maria Martinez', 'role': 'CONTACT', 'email': 'Maria.L.Martinez@uth.tmc.edu', 'phone': '713-500-6718'}], 'facility': 'Houston Advancing Research Team CRS (Site ID: 31473)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104-9929', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'contacts': [{'name': 'Christine Jonsson, EMBA', 'role': 'CONTACT', 'email': 'cjonsson@uw.edu', 'phone': '206-744-8886'}], 'facility': 'University of Washington Positive Research CRS (Site ID: 1401)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie results in the publication, after deidentification.', 'accessCriteria': '* With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections).\n* For what types of analyses? To achieve aims in the proposal approved by the ACTG.\n* By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}