The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients

Launched by ANDERSON CLINICAL RESEARCH · Aug 30, 2001

Nctid: NCT00002385

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-04", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Dose-Response Relationship, Drug", "Cohort Studies", "Anti-HIV Agents"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To identify doses of fozivudine tidoxil that are well tolerated and produce measurable antiviral activity.\n\nTo identify the adverse event profile that defines the maximum tolerated dose. To characterize the single- and multiple-dose pharmacokinetics of fozivudine and its metabolites.\n\nTo correlate the adverse event profile and antiviral activity of fozivudine with pharmacokinetic parameters.", "detailedDescription"=>"In this double-blind, dose-escalating study, patients receive fozivudine tidoxil at one of 5 dosage levels for 4 weeks and are randomized with respect to once- or twice-daily administration (cohorts 2 vs. 3 and 4 vs. 5). Within each cohort, 10 patients are randomized to the study drug and 2 to the placebo. At least 9 of the 12 patients enrolled in Cohort 1 must complete the entire 4-week course before Cohorts 2 and 3 are enrolled. At least 18 of these 24 patients must complete 2 weeks of the 4-week course before Cohorts 4 and 5 are enrolled."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nPrimary and secondary prophylaxis for opportunistic infection if stable and initiated at least 3 months prior to study drug administration.\n\nPatients must have:\n\n* HIV-positive status.\n* One HIV RNA count \\> 10,000 copies/ml within 30 days prior to entry, with a second count at least 3-fold above or below the first value.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Active medical problems including chronic diarrhea and active opportunistic infections such as cryptococcosis, Pneumocystis carinii, histoplasmosis, etc..\n* Malignancy for which systemic therapy or radiation therapy is expected to be required during the study.\n* Any other disease or condition that would place a patient at undue risk or confound the results of the study.\n\nConcurrent Medication:\n\nExcluded:\n\nSystemic therapy for malignancy.\n\nPrior Medication:\n\nExcluded:\n\n* Zidovudine or any other nucleoside reverse transcriptase inhibitor.\n* Immunomodulators within one month prior to study drug administration.\n* Investigational drugs within 30 days prior to study drug administration.\n* Systemic cytotoxic chemotherapy within 3 months prior to study drug administration.\n\nPrior Treatment:\n\nExcluded:\n\n* Extended-field radiation therapy within 3 months prior to study drug administration.\n* Blood transfusion within 2 weeks prior to study drug administration."}, "identificationModule"=>{"nctId"=>"NCT00002385", "briefTitle"=>"The Safety and Effectiveness of Fozivudine Tidoxil in HIV-1 Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Multicenter, Rising, Multiple-Dose, Placebo-Controlled, Dose-Response Study to Evaluate the Safety, Tolerability, and Anti-Viral Activity of 4 Weeks of Treatment With 200-800 Mg Fozivudine Tidoxil in Patients With HIV-1 Infection (MF4314).", "orgStudyIdInfo"=>{"id"=>"277A"}, "secondaryIdInfos"=>[{"id"=>"MF4314"}, {"id"=>"96ACR-BRM1"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Fozivudine tidoxil", "type"=>"DRUG"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Anderson Clinical Research", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Boehringer Mannheim", "class"=>"INDUSTRY"}]}}}