Nctid:
NCT00001024
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D000012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D000016180", "term"=>"Lentivirus Infections"}, {"id"=>"D000012192", "term"=>"Retroviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M3735", "name"=>"AIDS-Related Complex", "relevance"=>"LOW"}, {"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"=>"D000015215", "term"=>"Zidovudine"}, {"id"=>"D000016049", "term"=>"Didanosine"}], "ancestors"=>[{"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000000998", "term"=>"Antiviral Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D000044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"HPV", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Pertuzumab", "relevance"=>"HIGH"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>32}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"2002-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-11-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Didanosine", "AIDS-Related Complex", "Zidovudine", "Lymph Nodes", "Lymphoid Tissue"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Cohen OJ, Pantaleo G, Graziosi C, Niu M, Fauci AS. Effect of antiretroviral therapy on HIV burden and replication in lymphoid tissue. DATRI 003 Study Group. Int Conf AIDS. 1994 Aug 7-12;10(1):7 (abstract no 001B)"}]}, "descriptionModule"=>{"briefSummary"=>"Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to which antiretroviral therapy alters HIV replication in LT.\n\nClinical objectives: To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures of HIV replication in PB and LT. To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response.\n\nOne of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.", "detailedDescription"=>"One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.\n\nSixteen antiretroviral-naive patients are randomized to either remain antiretroviral-naive (no treatment) or receive zidovudine daily (treatment). Additionally, 16 patients with 26 or more weeks of ongoing zidovudine (AZT) therapy are randomized to either continue on their prestudy AZT regimen or add didanosine (ddI) daily to their baseline AZT dose. Patients remain on their assigned treatment arms for 8 weeks. A lymph node biopsy is performed on day 0 and at week 8. Patients are evaluated at weeks 2, 4, 6, 8 and 9."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Chemoprophylaxis against M. tuberculosis, therapy for oral candidiasis, and short courses (up to 10 days) of acyclovir for herpes lesions.\n* Antibiotics as clinically indicated.\n* Pneumococcal vaccine and hepatitis B vaccine as medically indicated.\n* Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or other medications deemed appropriate by the patient's primary care provider.\n\nRecommended:\n\n* PCP prophylaxis if patient's CD4 count falls below 200 cells/mm3 during the study.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Alternative therapies such as vitamins and acupuncture.\n\nPatients must have:\n\n* Documented HIV infection.\n* At least two palpable lymph nodes above the waist.\n* CD4 counts \\>= 350 cells/mm3 (if previously antiretroviral-naive) or \\>= 250 cells/mm3 (if receiving ongoing AZT therapy).\n\nPatients with prior AZT therapy must have received a stable dose of 300-600 mg daily for 26 or more weeks.\n\nPrior Medication:\n\nRequired in patients with prior ongoing therapy:\n\n* AZT at dose of 300-600 mg daily for at least 26 weeks.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* Severe malabsorption.\n* Current AIDS-related opportunistic infection, AIDS dementia, AIDS-wasting syndrome, or an AIDS-related malignancy other than minimal Kaposi's sarcoma disease.\n* Current medical problems that may interfere with the evaluation of AZT or increase the potential toxicity of AZT (e.g., significant liver disease, diabetes, significant cardiovascular disease, seizure disorders, lymphoma, acute or chronic pancreatitis, or febrile illness).\n* Current diagnosis of malignancy for which systemic therapy would be required during study.\n\nConcurrent Medication:\n\nExcluded:\n\n* Ganciclovir, foscarnet, chronic acyclovir, or probenecid.\n* Other proven or alleged antiretroviral or anti-HIV drugs.\n* Biologic response modifiers.\n* Valproic acid.\n* Systemic cytotoxic chemotherapy.\n* Steroids.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy.\n\nPatients with the following prior conditions are excluded:\n\n* Prior AIDS-related opportunistic infection, AIDS dementia, AIDS-wasting syndrome, or an AIDS-related malignancy other than minimal Kaposi's sarcoma disease.\n* History of medical problems that may interfere with the evaluation of AZT or increase the potential toxicity of AZT (e.g., significant liver disease, diabetes, significant cardiovascular disease, seizure disorders, lymphoma, acute or chronic pancreatitis, or febrile illness).\n* History of peripheral neuropathy (patients with prior AZT treatment only).\n\nPrior Medication:\n\nExcluded:\n\n* Prior ddI therapy.\n* Less than 26 weeks of prior AZT (in patients with ongoing AZT therapy only).\n* Ganciclovir, foscarnet, chronic acyclovir, or probenecid.\n* Cytotoxic chemotherapy within 1 month prior to study entry.\n* Acute therapy for an infection or other medical illness within 14 days prior to study entry.\n\nHistory of alcohol abuse (patients with prior AZT treatment)."}, "identificationModule"=>{"nctId"=>"NCT00001024", "briefTitle"=>"The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Multicenter, Open-Label Study of Viral Burden in Peripheral Blood Versus Lymphoid Tissue Before and After Antiretroviral Therapy in HIV-Infected Individuals Without AIDS (NOTE: One Arm Receives no Treatment)", "orgStudyIdInfo"=>{"id"=>"DATRI 003"}, "secondaryIdInfos"=>[{"id"=>"11734", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94304", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Palo Alto Veterans Affairs Health Care System", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Permanente Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Mount Zion Med Ctr / UCSF", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ of Illinois", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ of Maryland at Baltimore", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"117948153", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ Med Ctr", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"15261", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pittsburgh", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}], "overallOfficials"=>[{"name"=>"J Cohn", "role"=>"STUDY_CHAIR"}, {"name"=>"M Niu", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}, {"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
