Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-01-25 @ 5:17 AM
Study NCT ID:
NCT00317902
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2006-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT� (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068817', 'term': 'Epoetin Alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-17', 'studyFirstSubmitDate': '2006-04-21', 'studyFirstSubmitQcDate': '2006-04-21', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life (QOL) in anemic HIV-infected patients between Week 24 (or the last measurement) and the beginning of the maintenance phase'}], 'secondaryOutcomes': [{'measure': 'The effect of every other week PROCRIT (Epoetin alfa) dosing on maintaining target hemoglobin levels (>13 g/dL), transfusion utilization and safety in anemic HIV-infected patients measured from the beginning of the maintenance phase to Week 24.'}]}, 'conditionsModule': {'keywords': ['Anemia', 'erythropoetin', 'Epoetin alfa', 'erythropoetin recombinant', 'HIV, AIDS'], 'conditions': ['Anemia', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '18284320', 'type': 'DERIVED', 'citation': 'Levine AM, Salvato P, Leitz GJ; Champs 2 Study Group. Efficacy of epoetin alfa administered every 2 weeks to maintain hemoglobin and quality of life in anemic HIV-infected patients. AIDS Res Hum Retroviruses. 2008 Feb;24(2):131-9. doi: 10.1089/aid.2006.0200.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=931&filename=CR005131_CSR.pdf', 'label': 'An Open-Labeled Study to Evaluate The Effect of Every Other Week PROCRIT (Epoetin alfa) Dosing on Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study was to treat anemic (Hemoglobin (Hb) \\< 12 g/dL) HIV-infected subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of \\> 13 g/dL and then to assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.', 'detailedDescription': 'This was a Phase IV, open-label, non-randomized, multi-center study conducted in community based practices, physicians networks, or academic institutions in the US. This study included anemic (Hb \\< 12 g/dL) HIV-infected subjects and HIV/hepatitis C (HCV) co-infected subjects not receiving HCV treatment on a stable anti-retroviral therapy (ART) regimen for at least 4 weeks prior to enrollment.\n\nQuality of life assessments, laboratory results, and transfusion information were obtained during the study. Laboratory tests, vital signs (blood pressure), and incidence and severity of adverse events were collected and assessed.\n\nThe primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life in anemic HIV-infected patients. The primary hypothesis of interest was that the mean quality of life score (as measured by MOS-HIV General Health Perception score) at the end of the every other week (Q2W) maintenance phase was not lower than that at the beginning of the maintenance phase by more than 7 points.\n\nIt was anticipated that less frequent dosing, every other week, was more convenient for patients and will improve patient compliance. The starting dose (Baseline/Study Day 1) of PROCRIT (Epoetin alfa) for all eligible subjects was 40,000 U given subcutaneously QW. The maximum duration was 24 weeks. Subjects who achieved target Hb levels \\>= 13 g/dL were converted to a maintenance dose of PROCRIT (Epoetin alfa) sc Q2W.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understand and sign written informed consent\n* HIV-infected patients (as documented by HIV-RNA values)\n* HIV/HCV co-infected patients not receiving treatment\n* Hemoglobin \\< 12 g/dL unrelated to transfusion\n* Estimated life expectancy of \\> 9 months\n* Has been maintained on a stable antiretroviral regimen for at least four weeks prior to enrollment into this study.\n\nExclusion Criteria:\n\n* Acute, symptomatic opportunistic infection or other acute AIDS defining illness\n* Anemia attributable to factors other than HIV infection (i.e., iron, B12 or folate deficiencies, hemolysis, gastrointestinal bleeding)\n* HCV co-infected patients who are anticipated to receive treatment with ribavirin/interferon during the study period. Previous treatment with ribavirin/interferon must have been completed at least 12 weeks prior to study entry\n* Ferritin level \\< 40 ng/mL\n* Uncontrolled or severe cardiovascular disease including recent (\\< 6 months) myocardial infarction, uncontrolled hypertension or congestive heart failure'}, 'identificationModule': {'nctId': 'NCT00317902', 'briefTitle': 'An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT� (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ortho Biotech Products, L.P.'}, 'officialTitle': 'An Open-Label Study to Evaluate The Effect of Every Other Week PROCRIT (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients', 'orgStudyIdInfo': {'id': 'CR005131'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epoetin alfa', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ortho Biotech Products, L.P. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ortho Biotech Products, L.P.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ortho Biotech Products, L.P.', 'class': 'INDUSTRY'}}}}