Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-27 @ 7:05 PM
Study NCT ID:
NCT02269605
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2014-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046785', 'term': 'bryostatin 1'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2014-10-16', 'studyFirstSubmitQcDate': '2014-10-20', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracellular HIV-1 RNA (usRNA and msRNA) level before and after bryostatin-1 administration', 'timeFrame': 'Baseline visit and days 2 and 3 after the day of treatment'}], 'secondaryOutcomes': [{'measure': 'HIV-1 RNA level', 'timeFrame': 'Baseline visit, day 0 (15, 30, 60 minutes after begining of drug administration and 1, 2, 4, 8, 12 hours after begining of drug administration) and days 1, 2 and 3'}, {'measure': 'CD4+ and CD8+ T (CD38+ and HLA DR+ positive) cell level', 'timeFrame': 'Baseline visit, day 1 and day 3'}, {'measure': 'Episomal DNA with 2 LTRs level', 'timeFrame': 'Baseline visit, day 1 and day 3'}, {'measure': 'Adverse Events', 'timeFrame': 'From baseline visit to day 28 after drug administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV reservoir', 'Bryostatin'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '12525599', 'type': 'BACKGROUND', 'citation': 'Persaud D, Zhou Y, Siliciano JM, Siliciano RF. Latency in human immunodeficiency virus type 1 infection: no easy answers. J Virol. 2003 Feb;77(3):1659-65. doi: 10.1128/jvi.77.3.1659-1665.2003. No abstract available.'}, {'pmid': '12095377', 'type': 'BACKGROUND', 'citation': 'Blankson JN, Gallant JE, Quinn TC, Bartlett JG, Siliciano RF. Loss of HIV-1-specific immunity during treatment interruption in 2 chronically infected patients. JAMA. 2002 Jul 10;288(2):162-4. doi: 10.1001/jama.288.2.162-a. No abstract available.'}, {'pmid': '19265012', 'type': 'BACKGROUND', 'citation': 'Richman DD, Margolis DM, Delaney M, Greene WC, Hazuda D, Pomerantz RJ. The challenge of finding a cure for HIV infection. Science. 2009 Mar 6;323(5919):1304-7. doi: 10.1126/science.1165706.'}, {'pmid': '26891037', 'type': 'DERIVED', 'citation': 'Gutierrez C, Serrano-Villar S, Madrid-Elena N, Perez-Elias MJ, Martin ME, Barbas C, Ruiperez J, Munoz E, Munoz-Fernandez MA, Castor T, Moreno S. Bryostatin-1 for latent virus reactivation in HIV-infected patients on antiretroviral therapy. AIDS. 2016 Jun 1;30(9):1385-92. doi: 10.1097/QAD.0000000000001064.'}]}, 'descriptionModule': {'briefSummary': 'Phase I, randomized, double blind, placebo-controlled, dose-finding trial. The trial´s goal is to evaluate two different doses of Bryostatin on HIV-1 latency and reservoir in HIV-1 infected patients receiving antiretroviral treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients understanding the trial purpose\n* Patients between 18 and 50 years of age\n* Patients with chronic HIV-1 infection\n* Patients receiving antiretroviral treatment with at least 3 active drugs for at least 2 years\n* Undetectable viral load measured by ultra sensitive methods\n* CD4+ levels higher than 350 cells/mm3\n* Patients committed to use contraceptive methods during the trial and up to 3 months after.\n\nExclusion Criteria:\n\n* Previous antiretroviral treatment failure, as any viral load outbreak after having had undetectable HIV-1 load. Low grade, transitory outbreaks (\\<200 RNA copies/ml) resolved without treatment modifications are excluded\n* Patients planned to interrupt antiretroviral treatment during the trial\n* Patients receiving immunosuppressant or immunostimulant drugs, including valproic acid.\n* Pregnant women\n* Bryostatin-1 hypersensitivity\n* Being enrolled in another clinical trial or having participated in another clinical trial in the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT02269605', 'acronym': 'BRYOLAT', 'briefTitle': 'Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Bryostatin-1 Effect on HIV-1 Latency and Reservoir HIV-1 Infected Patients Receiving Antiretroviral Treatment: Pilot, Controlled, Double Blinded, Dose Searching Trial', 'orgStudyIdInfo': {'id': 'BRYOLAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1', 'description': 'Patients receiving placebo (sodium chloride) at single dose', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Patients receiving Bryostatin 1 (10ug/m2) at single dose', 'interventionNames': ['Drug: Bryostatin 1 (10ug/m2)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Patients receiving Bryostatin 1 (20ug/m2) at single dose', 'interventionNames': ['Drug: Bryostatin 1 (20ug/m2)']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Group 1: Placebo (sodium chloride 0.8 %) at single dose', 'armGroupLabels': ['Group 1']}, {'name': 'Bryostatin 1 (10ug/m2)', 'type': 'DRUG', 'description': 'Group 2: Bryostatin 1 (10ug/m2) at single dose', 'armGroupLabels': ['Group 2']}, {'name': 'Bryostatin 1 (20ug/m2)', 'type': 'DRUG', 'description': 'Group 3: Bryostatin 1 (20ug/m2) at single dose', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Non US/Canada', 'country': 'Spain', 'facility': 'Infectious Diseases Service', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Santiago Moreno, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramón y Cajal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}