Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-04 @ 3:47 PM
Study NCT ID:
NCT02191657
Status:
COMPLETED
Last Update Posted:
2014-07-16
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected Subjects
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': 'D000077543', 'term': 'Deferiprone'}, {'id': 'D020084', 'term': 'Long Interspersed Nucleotide Elements'}], 'ancestors': [{'id': 'D011728', 'term': 'Pyridones'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018626', 'term': 'Retroelements'}, {'id': 'D020071', 'term': 'Interspersed Repetitive Sequences'}, {'id': 'D012091', 'term': 'Repetitive Sequences, Nucleic Acid'}, {'id': 'D001483', 'term': 'Base Sequence'}, {'id': 'D015394', 'term': 'Molecular Structure'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D040481', 'term': 'Genome Components'}, {'id': 'D016678', 'term': 'Genome'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-14', 'studyFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of adverse events following repeated oral doses of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers', 'timeFrame': '9 weeks (from receipt of first dose until 8 weeks after the last dose)', 'description': 'Collection of adverse events, including abnormal findings in physical examination, vital signs, 12-lead ECG, 24-hour Holter ECG, and laboratory variables (hematology, clinical chemistry, and urinalysis)'}, {'measure': 'Measurement of viral load following repeated oral doses of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers', 'timeFrame': '9 weeks (pre-dose until 8 weeks after last dose)', 'description': 'Measurement of HIV RNA load for the assessment of antiretroviral activity'}, {'measure': 'Cluster of differentiation 4 (CD4) count and p24 antigen status following repeated oral doses of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers', 'timeFrame': '1 week (pre-dose to day of last dose)', 'description': 'Measurement of CD4 count and p24 antigen status for assessment of antiviral activity'}], 'secondaryOutcomes': [{'measure': 'Cmax of deferiprone and deferiprone 3-O-glucuronide', 'timeFrame': '24-hour interval', 'description': 'Determination of Cmax following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers'}, {'measure': 'Tmax of deferiprone and deferiprone 3-O-glucuronide', 'timeFrame': '24-hour interval', 'description': 'Determination of Tmax of deferiprone and its metabolite following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers'}, {'measure': 'Area under the curve (AUC) 0-infinity of deferiprone and deferiprone 3-O-glucuronide', 'timeFrame': '24-hour interval', 'description': 'Determination of AUC 0-infinity of deferiprone and its metabolite following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers'}, {'measure': 'T1/2 of deferiprone and deferiprone 3-O-glucuronide', 'timeFrame': '24-hour interval', 'description': 'Determination of T1/2 of deferiprone and its metabolite following a dose of deferiprone in asymptomatic HIV-infected subjects and healthy volunteers'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV', 'deferiprone', 'iron chelation'], 'conditions': ['HIV Infection']}, 'referencesModule': {'references': [{'pmid': '27191165', 'type': 'DERIVED', 'citation': "Saxena D, Spino M, Tricta F, Connelly J, Cracchiolo BM, Hanauske AR, D'Alliessi Gandolfi D, Mathews MB, Karn J, Holland B, Park MH, Pe'ery T, Palumbo PE, Hanauske-Abel HM. Drug-Based Lead Discovery: The Novel Ablative Antiretroviral Profile of Deferiprone in HIV-1-Infected Cells and in HIV-Infected Treatment-Naive Subjects of a Double-Blind, Placebo-Controlled, Randomized Exploratory Trial. PLoS One. 2016 May 18;11(5):e0154842. doi: 10.1371/journal.pone.0154842. eCollection 2016."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of different dosages of deferiprone in subjects with or without HIV infection.', 'detailedDescription': 'Three cohorts were enrolled: two of individuals who were asymptomatically infected with HIV and one of healthy volunteers. Dosages were as follows:\n\n* Cohort 1 (asymptomatic HIV infected subjects): 33 mg/kg deferiprone three times daily for a total of 99 mg/kg/day\n* Cohort 2 (healthy volunteers): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day\n* Cohort 3 (asymptomatic HIV infected subjects): 50 mg/kg deferiprone three times daily for a total of 150 mg/kg/day'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged ≥18 years and ≤ 60 years.\n* Absolute neutrophil count (ANC) of \\>1000/mm3 for African black population and ≥ 1600/mm3 for all other races.\n* For Cohort 2: HIV-negative\n* For Cohorts 1 and 3: HIV-1 positive; CD4 count of at least 300/mm3; HIV-1 RNA copies (viral load) \\>10 000 copies/mL serum; and current physical health stable and not requiring antiretroviral treatment\n* For Cohorts 1 and 3: Chest x-ray showing absence of active infectious diseases (such as tuberculosis, viral or atypical bacteria or parasitic infection).\n\nExclusion Criteria:\n\n* Presence of any severe concomitant disease.\n* History of or current, recurrent or recent (4 weeks) febrile disease.\n* History of opportunistic infections, neoplasm or AIDS-defining conditions.\n* Inability to discontinue any medication from screening onwards, or for at least 2 weeks before the first admission; in particular any antiviral or therapy with immunosuppressive activity.\n* Significant liver impairment: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≥ 2.5 times the upper normal limit.\n* Significant kidney impairment: serum creatinine ≥ two times the upper normal limit.\n* Any concomitant disorder or resultant therapy likely to have interfered with subject compliance or with study procedures.\n* Known hypersensitivity to any of the test materials or related compounds.\n* Positive test for Hepatitis B and/or C antibodies.\n* A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions.\n* History of seizures or epilepsy.'}, 'identificationModule': {'nctId': 'NCT02191657', 'briefTitle': 'Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'ApoPharma'}, 'officialTitle': 'A Double Blind, Placebo-controlled, Dose-escalating, Multiple Dose Study, Investigating the Safety, Antiretroviral Activity, Tolerability and Pharmacokinetic Profile of Deferiprone When Administered in Healthy Volunteers and Asymptomatic HIV Infected Subjects', 'orgStudyIdInfo': {'id': 'LA26-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Subjects in this arm were asymptomatic HIV-infected individuals who received a dose of 33 mg/kg deferiprone three times a day for a total daily dosage of 99 mg/kg', 'interventionNames': ['Drug: Deferiprone']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Subjects in this arm were healthy volunteers who received a dose of 50 mg/kg deferiprone three times a day for a total daily dosage of 150 mg/kg', 'interventionNames': ['Drug: Deferiprone']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Subjects in this arm were asymptomatic HIV-infected individuals who received a dose of 50 mg/kg deferiprone three times a day for a total daily dosage of 150 mg/kg.', 'interventionNames': ['Drug: Deferiprone']}], 'interventions': [{'name': 'Deferiprone', 'type': 'DRUG', 'otherNames': ['Ferriprox', 'L1'], 'description': 'Oral iron chelator', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9324', 'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'PAREXEL International', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}], 'overallOfficials': [{'name': 'Dewald Steyn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Free State, South Africa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ApoPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}