Nctid:
NCT00001688
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D019438", "term"=>"Ritonavir"}, {"id"=>"D019829", "term"=>"Nevirapine"}, {"id"=>"D018119", "term"=>"Stavudine"}], "ancestors"=>[{"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D065701", "term"=>"Cytochrome P-450 CYP3A Inducers"}, {"id"=>"D065693", "term"=>"Cytochrome P-450 Enzyme Inducers"}, {"id"=>"D000963", "term"=>"Antimetabolites"}], "browseLeaves"=>[{"id"=>"M21394", "name"=>"Ritonavir", "asFound"=>"Associated", "relevance"=>"HIGH"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M21717", "name"=>"Nevirapine", "asFound"=>"Restricted", "relevance"=>"HIGH"}, {"id"=>"M20272", "name"=>"Stavudine", "asFound"=>"Twenty", "relevance"=>"HIGH"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>25}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-01"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2001-11", "completionDateStruct"=>{"date"=>"2001-11"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-05-21", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-05-22", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["CD4 Cells", "Cytokines", "Anti-Retroviral Activity", "V Beta Repertoire", "CD-4-Naive T Cells", "CD-4-Memory T Cells"], "conditions"=>["HIV Infection"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8397771", "type"=>"BACKGROUND", "citation"=>"Yarchoan R, Mitsuya H, Broder S. Challenges in the therapy of HIV infection. Immunol Today. 1993 Jun;14(6):303-9. doi: 10.1016/0167-5699(93)90050-U. Erratum In: Immunol Today. 2008 Apr;29(4):149."}, {"pmid"=>"7691265", "type"=>"BACKGROUND", "citation"=>"Mackall CL, Granger L, Sheard MA, Cepeda R, Gress RE. T-cell regeneration after bone marrow transplantation: differential CD45 isoform expression on thymic-derived versus thymic-independent progeny. Blood. 1993 Oct 15;82(8):2585-94."}, {"pmid"=>"7800006", "type"=>"BACKGROUND", "citation"=>"Mackall CL, Fleisher TA, Brown MR, Andrich MP, Chen CC, Feuerstein IM, Horowitz ME, Magrath IT, Shad AT, Steinberg SM, et al. Age, thymopoiesis, and CD4+ T-lymphocyte regeneration after intensive chemotherapy. N Engl J Med. 1995 Jan 19;332(3):143-9. doi: 10.1056/NEJM199501193320303."}]}, "descriptionModule"=>{"briefSummary"=>"This is a pilot study to evaluate the ability of highly active antiretroviral therapy administered to children with HIV-1 infection to effect immunoreconstitution in children with HIV-1 infection. In addition, this study will determine the safety of combination therapy with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected children will be studied, including both moderately and severely immunocompromised individuals. The children will be treated with ritonavir, nevirapine and stavudine or with predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as the repopulation of naive T cells, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire. Drug pharmacokinetic profiles in this regimen will be examined.", "detailedDescription"=>"This is a pilot study to evaluate the ability of highly active antiretroviral therapy administered to children with HIV-1 infection to effect immunoreconstitution in children with HIV-1 infection. In addition, this study will determine the safety of combination therapy with ritonavir, nevirapine and stavudine (d4T) as well as the anti-HIV activity of combination therapy with ritonavir, nevirapine and stavudine. A total of 25 HIV-1 infected children will be studied, including both moderately and severely immunocompromised individuals. The children will be treated with ritonavir, nevirapine and stavudine or with predefined drug substitutions in the case of intolerance. Immunoreconstitution, defined as the repopulation of naive T cells, will be studied by determining the presence and extent of production of new naive (thymic derived) CD4+ T cells and their T cell receptor repertoire. Drug pharmacokinetic profiles in this regimen will be examined."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Children between ages of 4 years and 18 years.\n\nDiagnosis of HIV-1 infection as defined by the Centers for Disease Control (CDC) Definition.\n\nAvailability of a parent or guardian to provide Informed Consent.\n\nChild is not critically ill or clinically unstable.\n\nNo CDC categories N1 and A1 (1994 revised classification for HIV infection in children less than 13 years of age) and the CDC 1993 revised HIV classification and expanded AIDS surveillance definition for adolescents and adults.\n\nNon-presence of an active opportunistic infection requiring acute intervention at the time of entry (e.g. CMV, aspergillosis, cryptococcosis, Candida, etc.). Patients receiving treatment for an infection that requires prolonged treatment must have been stable on therapy for at least 30 days prior to study entry.\n\nNo administration of chemotherapeutic agents, investigational agents or use of immunomodulating agents such as IVIG, corticosteroids, interferons, pentoxifylline, G-CSF/GM-CSF, erythropoeitin, growth hormone and other growth factors within one month of enrollment.\n\nNone of the following laboratory abnormalities within 2 weeks of study entry:\n\nTotal WBC count less than 1500/mm(3) or an absolute neutrophil count less than 750/mm(3);\n\nHemoglobin less than 8.0 g/dl;\n\nPlatelet count less than 75,000/mm(3);\n\nCreatinine greater than 2.0 x normal;\n\nCreatinine clearance less than or equal to 50 mL/min/m(2);\n\nTotal bilirubin greater than 2 x normal;\n\nSGOT/SGPT greater than 5 x normal;\n\nSerum amylase pancreatic isoenzyme greater than 90 U/L (2 x upper limit of normal for adult). Serum amylase pancreatic isoenzyme should be obtained only if total serum amylase is greater than 180 U/L.\n\nNo history of clinical pancreatitis and/or elevation in serum amylase pancreatic isoenzyme of greater than 180 U/L.\n\nNo history of peripheral neuropathy of Grade II or greater severity.\n\nNo previous treatment with ritonavir, indinavir, nelfinavir, nevirapine or stavudine. Patients may have received treatment with ritonavir, indinavir, nelfinavir for less than 4 weeks.\n\nAbility to swallow tablets.\n\nNo child for whom the volume of research blood required for study evaluation exceeds the maximum volume of research blood allowable (3 ml/kg in a single blood withdrawal and 7 ml/kg in a 6-week period). This would be applicable to a child less than 16.5 kg.\n\nNo patients who refuse or cannot have leukapheresis done.\n\nSexually active post-menarchal females must be willing to use a barrier method of contraception or be willing to remain sexually abstinent."}, "identificationModule"=>{"nctId"=>"NCT00001688", "briefTitle"=>"A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir, Nevirapine and Stavudine", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"A Pilot Study of the Immunologic Reconstitution in HIV-1 Infected Children Receiving Highly Active Antiretroviral Therapy With Combination Ritonavir, Nevirapine and Stavudine", "orgStudyIdInfo"=>{"id"=>"980041"}, "secondaryIdInfos"=>[{"id"=>"98-C-0041"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ritonavir", "type"=>"DRUG"}, {"name"=>"Nevirapine", "type"=>"DRUG"}, {"name"=>"Stavudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Cancer Institute (NCI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}}}}
