Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00059358
Status:
COMPLETED
Last Update Posted:
2009-08-07
First Post:
2003-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zidovudine Levels in HIV Infected Patients Being Treated for HCV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D060085', 'term': 'Coinfection'}], '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'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'D000077190', 'term': 'Interferon alpha-2'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-06', 'studyFirstSubmitDate': '2003-04-23', 'studyFirstSubmitQcDate': '2003-04-23', 'lastUpdatePostDateStruct': {'date': '2009-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady state area under the concentration time curve (AUC) between 0 and 12 hours of zidovudine (ZDV)-MP, ZDV-TP, and dTTP in PBMCs from HIV and hepatitis C virus (HCV) coinfected patients before and after peginterferon alfa-2b with or without ribavirin', 'timeFrame': 'Throughout study'}, {'measure': 'Systemic exposure (AUC over 0 to 12 hours) of nelfinavir before and after peginterferon alfa-2b with or without ribavirin in HIV and HCV coinfected patients', 'timeFrame': 'Throughout study'}, {'measure': 'Effect of peginterferon alfa-2b with or without ribavirin in HCV RNA viral titers, alanine aminotransferase (ALT) levels, CD4+, and HIV-RNA viral titers in HIV and HCV coinfected patients', 'timeFrame': 'Through Week 48'}, {'measure': 'Effect of peginterferon alfa-2b with or without ribavirin on liver histology', 'timeFrame': 'At Week 72'}]}, 'conditionsModule': {'keywords': ['HIV', 'HCV', 'Ribavirin', 'Interferon', 'Co-infection', 'Treatment experienced'], 'conditions': ['HIV Infections', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study will test the amount of anti-HIV drugs in the blood cells of HIV-infected patients who are also being treated for hepatitis C virus (HCV) infection.', 'detailedDescription': 'An estimated 50,000 people in Puerto Rico are infected with HCV. HIV and HCV have similar routes of transmission, and HCV co-infection occurs in 8% to 23% of HIV infected patients. Researchers have shown that treatment for HCV with Rebetron (ribavirin plus interferon alfa-2b) significantly decreases HCV viral load without affecting HIV viral load. However, measurements of intracellular levels of the active forms of zidovudine (ZDV-MP and ZDV-TP) were not performed. Such measurements are needed to provide a more rational basis for dosing in HIV/HCV co-infected patients. This study will investigate the intracellular exposure to active ZDV metabolites prior to and after treatment with Rebetron or treatment with PEG-Intron (pegylated interferon) and ribavirin.\n\nParticipants in this study will remain on their usual antiretroviral regimen; no changes may be made to that regimen for the first 4 weeks of the study. Upon study entry, participants will have intracellular pharmacokinetic studies. During Week 2, participants will start either Rebetron or PEG-Intron plus ribavirin therapy, will have intracellular pharmacokinetic studies, and will undergo liver biopsy. Additional intracellular pharmacokinetic studies will be performed at Weeks 12 and 24. Rebetron or PEG-Intron plus ribavirin will be given for 48 weeks. A second liver biopsy will be performed 24 weeks after discontinuing Rebetron or PEG-Intron plus ribavirin therapy. Participants will be followed for 72 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* HCV-infected\n* HIV-1 infection\n* CD4 cell count \\> 200 cells/mm³ within 30 days prior to study entry\n* HIV RNA \\< 400 copies/ml within 90 days of study entry\n* Use of zidovudine, lamivudine, and any PI and/or NNRTI\n* ANC value \\>= 1,500 ml³ within 30 days of study entry\n* Weight \\> 50 kg (110 lbs) for women and \\> 60 kg (132 lbs) for men\n* Acceptable methods of contraception\n* Ability and willingness to complete the Baseline Adherence Questionnaire\n* Documentation of adherence confirmed by the Baseline Adherence Questionnaire and certified by the study officials\n\nExclusion Criteria\n\n* Previous ribavirin therapy\n* More than 2 months of interferon therapy\n* Current use of any NRTI other than ZDV and 3TC\n* Hepatitis B surface antigen positive\n* Infectious, autoimmune, tumoral, biliary, or vascular liver disease\n* Alcohol consumption of more than 50 g/day\n* Current use of intravenous drugs\n* Hemoglobin levels \\< 10 gm/dl\n* Methadone use\n* Chemotherapy\n* Certain medications\n* Acute opportunistic or bacterial infection requiring therapy at the time of enrollment\n* Hemoglobinopathy (e.g., thalassemia) or any other cause of tendency to hemolysis\n* Psychiatric disorders, severe depression, history of suicide attempts, or suicidal ideation\n* Renal disease requiring dialysis\n* Significant coronary diseases or two or more risk factors for coronary diseases, such as \\> 55 years old, hypertension, and cholesterol \\> 250 mg/dl\n* Any clinically significant diseases (other than HIV and HCV infection) that, in the opinion of study officials, would compromise the outcome of this study\n* Pregnancy\n* Participation in blinded clinical trial'}, 'identificationModule': {'nctId': 'NCT00059358', 'briefTitle': 'Zidovudine Levels in HIV Infected Patients Being Treated for HCV', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Pharmacological Interactions Between Zidovudine and Ribavirin in HCV-HIV Co-Infected Patients Treated With Rebetron or Peg-Intron Plus Ribavirin', 'orgStudyIdInfo': {'id': '1R01AI09141-01A1'}, 'secondaryIdInfos': [{'id': '5R01AI049141-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01AI049141-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will begin receive either Rebetron or PEG-Intron plus ribavirin therapy from Weeks 2 through 48', 'interventionNames': ['Drug: Ribavirin plus interferon alfa-2b', 'Drug: Ribavirin', 'Drug: Peginterferon alfa-2b']}], 'interventions': [{'name': 'Ribavirin plus interferon alfa-2b', 'type': 'DRUG', 'description': 'Oral tablets taken daily', 'armGroupLabels': ['1']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Oral tablet taken daily', 'armGroupLabels': ['1']}, {'name': 'Peginterferon alfa-2b', 'type': 'DRUG', 'description': 'Subcutaneous injection', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00936-5067', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'UPR Adult ACTU', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Jose F. Rodriguez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MSC-UPR'}, {'name': 'Jorge L. Santana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MSC-UPR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Jose F. Rodriguez, PhD', 'oldOrganization': 'MSC-UPR'}}}}