Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-04-22 @ 2:37 AM
Study NCT ID:
NCT01836068
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2013-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006679', 'term': 'HIV Seropositivity'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D000077560', 'term': 'Enfuvirtide'}], 'ancestors': [{'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015700', 'term': 'HIV Envelope Protein gp41'}, {'id': 'D014760', 'term': 'Viral Fusion Proteins'}, {'id': 'D050576', 'term': 'Membrane Fusion Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D015488', 'term': 'HIV Antigens'}, {'id': 'D000956', 'term': 'Antigens, Viral'}, {'id': 'D014764', 'term': 'Viral Proteins'}, {'id': 'D054299', 'term': 'env Gene Products, Human Immunodeficiency Virus'}, {'id': 'D015686', 'term': 'Gene Products, env'}, {'id': 'D012191', 'term': 'Retroviridae Proteins'}, {'id': 'D054298', 'term': 'Human Immunodeficiency Virus Proteins'}, {'id': 'D014759', 'term': 'Viral Envelope Proteins'}, {'id': 'D015678', 'term': 'Viral Structural Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2013-04-16', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence of acute graft-vs-host disease', 'timeFrame': '2 years post-intervention', 'description': 'Describe the incidence of acute graft-vs-host disease via the Keystone criteria'}, {'measure': 'The severity of acute graft-vs-host disease', 'timeFrame': '2 years post-intervention', 'description': 'Describe the severity of acute graft-vs-host disease via the Keystone criteria'}, {'measure': 'The incidence of chronic graft-vs-host disease as defined by the NIH consensus criteria', 'timeFrame': '2 years post-intervention', 'description': 'Describe the incidence chronic graft-vs-host disease via the NIH consensus criteria.'}, {'measure': 'The incidence of chronic graft-vs-host disease as defined by the Seattle criteria', 'timeFrame': '2 years post-intervention', 'description': 'Describe the incidence chronic graft-vs-host disease via the Seattle criteria.'}, {'measure': 'The severity of chronic graft-vs-host disease as defined by the NIH consensus criteria', 'timeFrame': '2 years post-intervention', 'description': 'Describe the severity of chronic graft-vs-host disease via the NIH consensus criteria and the Seattle criteria'}, {'measure': 'The severity of chronic graft-vs-host disease as defined by the Seattle criteria', 'timeFrame': '2 years post-intervention', 'description': 'Describe the severity of chronic graft-vs-host disease via the Seattle criteria'}], 'primaryOutcomes': [{'measure': 'Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic HSCT', 'timeFrame': '24 hours', 'description': 'Failure to maintain anti retroviral therapy for 24 hours'}], 'secondaryOutcomes': [{'measure': 'Number of copies of HIV-1 DNA in blood mononuclear cells at baseline', 'timeFrame': 'Baseline', 'description': 'Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.'}, {'measure': 'Number of copies of HIV-1 DNA in blood mononuclear cells at 12 weeks', 'timeFrame': '12 weeks post-intervention', 'description': 'Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.'}, {'measure': 'Number of copies of HIV-1 DNA in blood mononuclear cells at 24 weeks', 'timeFrame': '24 weeks post-intervention', 'description': 'Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.'}, {'measure': 'Number of copies of HIV-1 DNA in blood mononuclear cells at 36 weeks', 'timeFrame': '36 weeks post-intervention', 'description': 'Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.'}, {'measure': 'Number of copies of HIV-1 DNA in blood mononuclear cells at 52 weeks', 'timeFrame': '52 weeks post-intervention', 'description': 'Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.'}, {'measure': 'Number of copies of HIV-1 DNA in blood mononuclear cells at 2 years', 'timeFrame': '2 years post-intervention', 'description': 'Measure the number of copies of HIV-1 DNA per million peripheral blood mononuclear cells.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV positive', 'HIV-1', 'Bone Marrow Transplant', 'Allogeneic BMT', 'BMT'], 'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '34753870', 'type': 'DERIVED', 'citation': 'Capoferri AA, Redd AD, Gocke CD, Clark LR, Quinn TC, Ambinder RF, Durand CM. Brief Report: Rebound HIV Viremia With Meningoencephalitis After Antiretroviral Therapy Interruption After Allogeneic Bone Marrow Transplant. J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):297-302. doi: 10.1097/QAI.0000000000002862.'}, {'pmid': '34107771', 'type': 'DERIVED', 'citation': 'Capoferri AA, Redd AD, Gocke CD, Clark LR, Ambinder RF, Durand CM. Short Communication: Persistence of HIV After Allogeneic Bone Marrow Transplant in a Dually Infected Individual. AIDS Res Hum Retroviruses. 2022 Jan;38(1):33-36. doi: 10.1089/AID.2021.0047. Epub 2021 Jul 5.'}, {'pmid': '32649866', 'type': 'DERIVED', 'citation': 'Durand CM, Capoferri AA, Redd AD, Zahurak M, Rosenbloom DIS, Cash A, Avery RK, Bolanos-Meade J, Bollard CM, Bullen CK, Flexner C, Fuchs EJ, Gallant J, Gladstone DE, Gocke CD, Jones RJ, Kasamon YL, Lai J, Levis M, Luznik L, Marr KA, McHugh HL, Mehta Steinke S, Pham P, Pohlmeyer C, Pratz K, Shoham S, Wagner-Johnston N, Xu D, Siliciano JD, Quinn TC, Siliciano RF, Ambinder RF. Allogeneic bone marrow transplantation with post-transplant cyclophosphamide for patients with HIV and haematological malignancies: a feasibility study. Lancet HIV. 2020 Sep;7(9):e602-e610. doi: 10.1016/S2352-3018(20)30073-4. Epub 2020 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'To find out if it is possible for HIV-1 patients to maintain antiretroviral medications during allogeneic bone marrow transplant', 'detailedDescription': 'Determine the feasibility of maintaining optimal ART in HIV-1 infected patients during allogeneic hematopoietic stem cell transplant (HSCT). The primary outcome is the fraction of patients who maintain any form of anti-retroviral therapy, including enfuvirtide monotherapy, through day 60 post-transplant. If patients are unable to take oral anti-retroviral medications, but are able to tolerate subcutaneous enfuvirtide monotherapy this will be considered maintenance of ART. Failure to maintain ART will be defined as ≥ 24 hours without any anti-retroviral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry. Alternatively, two HIV-1 RNA values \\> 200 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent may be used to document infection.\n* Patients must be ≥ 18 years of age.\n* Plan to undergo a Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:\n* Plan to undergo a Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy using bone marrow from a related donor:\n\nExclusion Criteria:\n\n* Patients with a known history of enfuvirtide resistance will not be eligible for this trial.'}, 'identificationModule': {'nctId': 'NCT01836068', 'briefTitle': 'Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1-infected Individuals', 'orgStudyIdInfo': {'id': 'J1331'}, 'secondaryIdInfos': [{'id': 'NA_00083734', 'type': 'OTHER', 'domain': 'Johns Hopkins'}, {'id': '1P30AI094189-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1P30AI094189-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enfuvirtide monotherapy', 'description': 'Enfuvirtide 90 mg subcutaneously every 12 hours will be also be administered during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions with conditioning regimens in patients who require ritonavir-boosted PI containing ART regimens.', 'interventionNames': ['Drug: Enfuvirtide']}], 'interventions': [{'name': 'Enfuvirtide', 'type': 'DRUG', 'otherNames': ['Fuzeon'], 'description': 'Enfuvirtide 90 mg subcutaneously twice daily will be administered to all patients on day 3 and 4 post-transplant and during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions', 'armGroupLabels': ['Enfuvirtide monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Sidney Kimmel Comprehensive Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Richard Ambinder, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}