Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT03399903
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2018-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2018-01-09', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammation markers', 'timeFrame': '14 weeks', 'description': 'C-reactive protein'}], 'secondaryOutcomes': [{'measure': 'Flow cytometry for cellular immune activation', 'timeFrame': '14 weeks', 'description': 'Immune activation'}, {'measure': 'Plasma markers of microbial translocation', 'timeFrame': '14 weeks', 'description': 'Microbial translocation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1-infection', 'Gut Inflammation']}, 'descriptionModule': {'briefSummary': 'An open label study will be performed on 80 people with HIV infection who are maintained on effective treatment with antiretroviral drugs.', 'detailedDescription': 'The goal of this study is to test whether a bowel anti-inflammatory drug that is known to be safe and effective for inflammatory bowel disease would offer benefit in reducing the residual immune activation associated with treated HIV-1 infection. Specifically, the two immediate goals are to examine the safety of Pentasa® in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at least 18\n* On ART for at least 1 year during which: viremia \\<50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of \\<100), and CD4 T cell count consistently \\>500 during that time\n* CD4 T cell nadir \\>350\n* Last CD4 and T cell test in past 6 months\n\nExclusion Criteria:\n\n* Plans to modify antiretroviral therapy in the next 12 weeks for any reason\n* History of inflammatory bowel disease or irritable bowel disease\n* Chronic active hepatitis B or C\n* History of autoimmune disease\n* Hypersensitivity to any component of Pentasa\n* Clostridium difficile infection\n* Receiving rectally delivered medications\n* Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors)\n* Receiving immunosuppressive steroids\n* Receiving any medications associated with bleeding risk\n* Hemoglobin \\< 10.0 g/dL\n* Platelet count less than 100,000/mm3\n* White blood cell count \\< 2,000 cells/mm3 or \\> 15,000 cells/mm3\n* Symptoms of sexually transmitted infection\n* Antibiotics used in the last 90 days\n* Renal insufficiency with creatinine clearance less than 50 ml/min\n* Elevated transaminases greater than 2.5 times the upper limit of normal\n* Evidence of decompensated cirrhosis, heart failure\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT03399903', 'briefTitle': 'Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'AIDS Healthcare Foundation'}, 'officialTitle': 'Study of Pentasa® for Reducing Residual Systemic Immune Activation in Treated HIV Infection', 'orgStudyIdInfo': {'id': 'HII-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pentasa', 'description': '40 participants will be randomized to take 1 gram of Pentasa, twice daily for 8 weeks', 'interventionNames': ['Drug: Pentasa vs Align']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Align', 'description': '40 participants will be randomized to take Align tablets, once daily for 8 weeks', 'interventionNames': ['Drug: Pentasa vs Align']}], 'interventions': [{'name': 'Pentasa vs Align', 'type': 'DRUG', 'description': 'We will examine the safety and possible effectiveness of Pentasa® and Align in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.', 'armGroupLabels': ['Align', 'Pentasa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation - Public Health Division', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Otto O Yang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AIDS Healthcare Foundation - HIV Immunotherapeutics Institute'}, {'name': 'Peter Anton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIDS Healthcare Foundation - HIV Immunotherapeutics Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AIDS Healthcare Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'HIV Immunotherapeutics Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}