Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-28 @ 10:23 PM
Study NCT ID:
NCT02456558
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive 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': 'D007531', 'term': 'Isoflurophate'}, {'id': 'D000077543', 'term': 'Deferiprone'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D063066', 'term': 'Organofluorophosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011728', 'term': 'Pyridones'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-03', 'studyFirstSubmitDate': '2015-05-26', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HIV viral load', 'timeFrame': 'Day 1 to Day 56'}, {'measure': 'Change from baseline in CD4+ T-cell count', 'timeFrame': 'Day 1 to Day 56'}, {'measure': 'Change from baseline in level of HIV DNA in peripheral blood mononucleated cells', 'timeFrame': 'Day 1 to Day 56'}, {'measure': 'Proportion of subjects withdrawn due to the need for rescue medication', 'timeFrame': 'Day 1 to Day 56'}, {'measure': 'Number of subjects with adverse events', 'timeFrame': 'Day 1 to Day 56'}], 'secondaryOutcomes': [{'measure': 'The pharmacokinetics parameters of Cmax, Tmax, and AUC0-∞, and T1/2 for deferiprone will be determined pre-dose and at specified time points post-dose', 'timeFrame': '10-hour interval'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV infection', 'antiretroviral drugs', 'deferiprone', 'pharmacokinetics'], 'conditions': ['Asymptomatic HIV Infection']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.', 'detailedDescription': 'This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive adults. There are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 positive\n* HIV treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cART) or highly active anti-retroviral therapy (HAART) regimen\n* HIV-1 RNA \\> 10,000 copies/mL\n* ALT or AST ≤ 2.0 x upper limit of normal range, and bilirubin within normal range\n* Body mass index (BMI) of 18.5 to 30.0 kg/m\\^2\n* Absolute neutrophil count at baseline of ≥1.0 x 10\\^9/L (black African population only) or ≥1.5 x 10\\^9/L (all other races)\n\nExclusion Criteria:\n\n* Evidence of AIDS-associated illness, excluding superficial candidiasis\n* CD4+ T-cell count of \\< 350/mm\\^3\n* Positive for active or latent tuberculosis, as determined by the QuantiFERON®-TB Gold test\n* Active, serious infections (other than HIV-1 infection) within the 30 days prior to screening\n* Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis virus C (HCV) antibodies\n* History or presence of malignancy\n* A serious, unstable chronic illness during the past 3 months before screening\n* A serious, unresolved acute illness at screening'}, 'identificationModule': {'nctId': 'NCT02456558', 'briefTitle': 'Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'ApoPharma'}, 'officialTitle': 'A Phase Ib Randomized, Double-blind, Placebo-controlled, Ascending Sequential Dose, Adaptive Design Study to Evaluate the Safety, Antiretroviral Activity, and Pharmacokinetics of Intravenous Deferiprone in Treatment-Naïve HIV-Positive Subjects', 'orgStudyIdInfo': {'id': 'LA44-0114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous deferiprone, 1.5 g', 'description': 'Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily', 'interventionNames': ['Drug: Intravenous deferiprone']}, {'type': 'EXPERIMENTAL', 'label': 'Intravenous deferiprone, 2 g', 'description': 'Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily', 'interventionNames': ['Drug: Intravenous deferiprone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects in this arm will receive an infusion of placebo twice-daily for 10 days, at a volume equivalent to that of the active product in the respective cohort', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Intravenous deferiprone', 'type': 'DRUG', 'otherNames': ['IV DFP', 'Deferiprone injection, solution'], 'description': 'In Cohort 1, the subjects who were randomized to get active product will receive deferiprone at a dose of 1.5 g per infusion, and if there are no significant safety concerns, the subjects in Cohort 2 who were randomized to get active product will receive it a a dose of 2 g per infusion.', 'armGroupLabels': ['Intravenous deferiprone, 1.5 g', 'Intravenous deferiprone, 2 g']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline solution (0.9% w/v NaCl)'], 'description': 'In both cohorts, the subjects who were randomized to get placebo will receive an infusion of placebo solution that is equal in volume to that of the active product.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6001', 'city': 'Port Elizabeth', 'state': 'Eastern Cape', 'country': 'South Africa', 'facility': 'Phoenix Pharma', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '0087', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'VxPharma', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ApoPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}