Nctid:
NCT00001080
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-28", "removedCountries"=>["United States"]}, "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"=>"M13904", "name"=>"Pneumonia", "relevance"=>"LOW"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10295", "name"=>"Influenza, Human", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M13908", "name"=>"Pneumonia, Pneumococcal", "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"=>"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"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D019259", "term"=>"Lamivudine"}, {"id"=>"D014612", "term"=>"Vaccines"}, {"id"=>"D000069443", "term"=>"Heptavalent Pneumococcal Conjugate Vaccine"}], "ancestors"=>[{"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Spray", "relevance"=>"HIGH"}, {"id"=>"M17360", "name"=>"Vaccines", "asFound"=>"Other", "relevance"=>"HIGH"}, {"id"=>"M412", "name"=>"Heptavalent Pneumococcal Conjugate Vaccine", "asFound"=>"Castration-Resistant Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "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"}, {"id"=>"M25428", "name"=>"Anti-Retroviral 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", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>0}}, "statusModule"=>{"whyStopped"=>"as of 4/23/97", "overallStatus"=>"WITHDRAWN", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "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"=>["Lymphocyte Transformation", "HIV-1", "Drug Resistance, Microbial", "CD4-Positive T-Lymphocytes", "Lamivudine", "Influenza Vaccine", "RNA, Viral", "Bacterial Vaccines", "Anti-HIV Agents", "Pneumonia, Pneumococcal", "Viral Load"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To ascertain whether the origin of plasma HIV-1-RNA following T cell activation represents the activation of latently infected cells or an increase in cells permissive for replacing viral mutants.\n\nThe mechanism by which immune stimulation increases circulating levels of HIV-1 is not known. In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1, or is due instead to activation of proviral sequences in previously resting CD4+ cells. One approach to discriminate these alternatives is a \"molecular pulse-chase\" experiment. In this approach, drug resistant mutants would be selected by administration of Lamivudine (3TC).", "detailedDescription"=>"The mechanism by which immune stimulation increases circulating levels of HIV-1 is not known. In particular, it is uncertain whether the transient increase in plasma HIV-1 RNA is due to enhanced replication of an actively replicating pool of HIV-1, or is due instead to activation of proviral sequences in previously resting CD4+ cells. One approach to discriminate these alternatives is a \"molecular pulse-chase\" experiment. In this approach, drug resistant mutants would be selected by administration of Lamivudine (3TC).\n\nTwenty subjects without prior 3TC experience will be treated with 3TC for 2 weeks. On day 14, half of the subjects will receive immunization with both the influenza and pneumococcal vaccine. 3TC will be discontinued at this time. Patients will be followed for 4 weeks after the immunization."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Antiretroviral therapy, provided the patient has been on the same dose and drugs for 60 days prior to study entry.\n\nPatients must have:\n\n* Documented HIV infection.\n* CD4 lymphocyte count of \\> 300 cells/mm3.\n* One plasma HIV-1 RNA level between \\>= 20,000 and \\< 120,000 copies/ml.\n\nPrior Medication:\n\nAllowed:\n\n* Stable antiretroviral therapy.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms and conditions are excluded:\n\n* Presence of an AIDS defining opportunistic infection, including Kaposi's sarcoma.\n* Allergy to influenza or pneumococcal vaccine or their components; to egg or egg products.\n* Unexplained temperature \\>= 38.5 degrees C for 7 consecutive days within the 30 days prior to study entry.\n* Concurrent participation in other experimental therapies.\n\nConcurrent Medication:\n\nExcluded:\n\n* Systemic chemotherapy.\n* Steroids.\n* Corticosteroids.\n* Vaccinations.\n* Any new antiretroviral agents that the patient was not taking at the time of study entry and not prescribed by the study.\n* Colony stimulating factors including G-CSF or rEPO.\n* Immune modulators/immune based therapies.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy.\n* Transfusion dependent patients.\n\nPatients with any of the following prior conditions are excluded:\n\n* History of an AIDS defining opportunistic infection, including Kaposi's sarcoma (except limited cutaneous diseases \\[\\< 5 lesions\\]).\n* History of acute or chronic pancreatitis.\n\nPrior Medication:\n\nExcluded:\n\n* Prior treatment with 3TC.\n\nExcluded within 30 days of study entry:\n\n* Treatment with immune modulators.\n* Acute or chronic therapy for recognized infections (eg, influenza, HSV, VZV).\n\nExcluded within 1 year of study entry:\n\nTreatment with an influenza and/or pneumonia vaccine\n\n\\[AS PER AMENDMENT 1/23/97:\n\n* influenza vaccine only\\].\n\n\\[AS PER AMENDMENT 1/23/97:\n\n* Excluded within 3 years of study entry:\n* Pneumonia vaccine.\\]"}, "identificationModule"=>{"nctId"=>"NCT00001080", "briefTitle"=>"Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Effect of Vaccination on Turnover of Lamivudine (3TC) Sensitive and Resistant Virus Populations in HIV-1-Infected Individuals", "orgStudyIdInfo"=>{"id"=>"ACTG 340"}, "secondaryIdInfos"=>[{"id"=>"11311", "type"=>"REGISTRY", "domain"=>"DAIDS ES Registry Number"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Influenza Virus Vaccine", "type"=>"BIOLOGICAL"}, {"name"=>"Pneumococcal Vaccine, Polyvalent (23-valent)", "type"=>"BIOLOGICAL"}, {"name"=>"Lamivudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Kuritzkes D", "role"=>"STUDY_CHAIR"}, {"name"=>"Richman D", "role"=>"STUDY_CHAIR"}, {"name"=>"Havlir D", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}