Nctid:
NCT00001078
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D009894", "term"=>"Opportunistic Infections"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M9592", "name"=>"Hepatitis A", "relevance"=>"LOW"}, {"id"=>"M9591", "name"=>"Hepatitis", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M9742", "name"=>"HIV Seropositivity", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "asFound"=>"Opportunistic Infections", "relevance"=>"HIGH"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M17360", "name"=>"Vaccines", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2005-07", "lastUpdateSubmitDate"=>"2011-03-01", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2011-03-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2005-05", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Viral Vaccines", "AIDS-Related Opportunistic Infections", "Anti-HIV Agents", "Hepatitis A Virus, Human"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"19617848", "type"=>"RESULT", "citation"=>"Weinberg A, Huang S, Fenton T, Patterson-Bartlett J, Gona P, Read JS, Dankner WM, Nachman S; IMPAACT P1008 Team. Virologic and immunologic correlates with the magnitude of antibody responses to the hepatitis A vaccine in HIV-infected children on highly active antiretroviral treatment. J Acquir Immune Defic Syndr. 2009 Sep 1;52(1):17-24. doi: 10.1097/QAI.0b013e3181b011f6."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to find out if it is safe for HIV-positive children who are responding well to their anti-HIV treatment to stop taking medications that prevent AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial infections. This is an observational study, meaning children will only be monitored to see if they develop any infections.\n\nChildren have been receiving medications to prevent complications of HIV infection, such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease, or other bacterial infections. It is common for HIV-positive patients with low CD4 counts to receive these preventive medications. However, these drugs can have serious side effects, they are expensive, and it is possible for bacteria resistant to the drugs to grow. For these reasons, it may be beneficial to the child to stop taking these preventive medications if he/she has been on anti-HIV (antiretroviral) therapy and has improved CD4 counts. This study will look at how many children who stop taking their medications develop opportunistic infections.", "detailedDescription"=>"Due to the strong correlation between a significant decrease in CD4 count and the frequency and magnitude of OIs such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC), and severe bacterial infections, CD4 count has become the major criterion for initiating antimicrobial prophylaxis for OIs. However, despite the benefits of these antimicrobial drugs, all are associated with adverse side effects, and patients with reconstituted immune systems following antiretroviral therapy may be receiving prophylaxis unnecessarily. Benefits to stopping prophylaxis include: (1) elimination of adverse effects from drugs; (2) reduction in drug costs; and (3) removal of selective pressure for the development of drug-resistant microbes. These benefits must be weighed against the disadvantages, however, such as more frequent determinations of CD4 counts to assure maintenance of immunocompetence, more frequent occurrence of serious OIs otherwise preventable with prophylaxis in patients lost to follow-up, and possible occurrence of atypical PCP because of prior exposure to anti-PCP drugs. \\[AS PER AMENDMENT 04/26/02: The extent of complete immune restitution has not yet been defined. An important corollary of an incomplete immune recovery is that vaccination schedules might need to be adjusted to obtain optimal responses in HIV-infected patients on highly active antiretroviral therapy (HAART). Therefore, a third dose of hepatitis A virus vaccine will be administered.\\]\n\nAfter pre-entry and entry laboratory studies, patients are followed every 8 weeks until the last patient has completed 104 weeks of study observation. Hepatitis A vaccination is administered at entry and Week 24 to measure responses to neoantigen. \\[AS PER AMENDMENT 04/26/02: All patients (except those co-enrolled in P1024 on or after November 1, 2001) who have received 2 doses of hepatitis A virus vaccine during the study will be offered an opportunity to enroll in Step II of P1008. Patients in Step II receive a third dose of hepatitis A vaccination at Week 104 or later. Additional blood samples are taken 8 weeks later for antibody detection and peripheral blood mononuclear cell (PBMC) cryopreservation.\\] All serious bacterial infections that are Grade 3 or higher and OI events are recorded and compared to historical event rates. Virologic and immunologic marker studies are done in all patients and correlated with the risk of developing serious bacterial infections or OI events. Patients are considered to have reached an endpoint if they develop PCP, 2 serious bacterial infections, other Category C OI diagnoses, or CD4% less than 15% and re-initiation of PCP prophylaxis."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"21 years", "minimumAge"=>"2 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nChildren may be eligible for this study if they:\n\n* Are HIV-positive.\n* Have a CD4 percent greater than or equal to 25 percent if they are under 6 years of age, or have a CD4 percent greater than or equal to 20 percent on 2 occasions if they are between the ages of 6 and 21.\n* Have been receiving preventive treatment for PCP for at least 6 months and have not stopped treatment for more than 3 months before study entry.\n* Are willing to stop taking preventive treatment for PCP and MAC.\n* Have received the same continuous antiretroviral (anti-HIV) therapy for the 16 weeks before beginning the study. (Continuous therapy means missing no more than a total of 3 weeks during the 16 weeks.)\n* Are between the ages of 2 and 21 years (consent of parent or guardian is required if under 18).\n\nExclusion Criteria\n\nChildren will not be eligible for this study if they:\n\n* Have PCP.\n* Have any other active infection, such as tuberculosis or toxoplasmosis, or any other significant disease.\n* Are receiving chemotherapy for cancer or certain other medications."}, "identificationModule"=>{"nctId"=>"NCT00001078", "briefTitle"=>"A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"An Observational Study of the Rate of Opportunistic Infection Events in HIV-Infected Children Who Have Demonstrated Immunologic Reconstitution and Who Have Discontinued OI Prophylaxis", "orgStudyIdInfo"=>{"id"=>"ACTG P1008"}, "secondaryIdInfos"=>[{"id"=>"PACTG P1008"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Hepatitis A Vaccine (Inactivated)", "type"=>"BIOLOGICAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35233", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Univ of Alabama at Birmingham - Pediatric", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"85006", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"Phoenix Childrens Hosp", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"920930672", "city"=>"La Jolla", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Med Ctr / Pediatrics / Clinical Sciences", "geoPoint"=>{"lat"=>32.84727, "lon"=>-117.2742}}, {"zip"=>"90801", "city"=>"Long Beach", "state"=>"California", "country"=>"United States", "facility"=>"Long Beach Memorial (Pediatric)", "geoPoint"=>{"lat"=>33.76696, "lon"=>-118.18923}}, {"zip"=>"900276016", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp of Los Angeles/UCLA Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Los Angeles County - USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"905022004", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Harbor - UCLA Med Ctr / UCLA School of Medicine", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"946091809", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Children's Hosp of Oakland", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"zip"=>"941430105", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF / Moffitt Hosp - Pediatric", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"802181088", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Children's Hosp of Denver", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"06504", "city"=>"New Haven", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Yale Univ Med School", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}, {"zip"=>"200102916", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Children's Hosp of Washington DC", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20060", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Howard Univ Hosp", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"32209", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Florida Health Science Ctr / Pediatrics", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33161", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami (Pediatric)", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33404", "city"=>"Riviera Beach", "state"=>"Florida", "country"=>"United States", "facility"=>"Palm Beach County Health Dept", "geoPoint"=>{"lat"=>26.77534, "lon"=>-80.0581}}, {"zip"=>"30306", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Emory Univ Hosp / Pediatrics", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Cook County Hosp", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ of Illinois College of Medicine / Pediatrics", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"606143394", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Children's Memorial Hosp", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"701122699", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Univ / Charity Hosp of New Orleans", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Univ of Maryland at Baltimore / Univ Med Ctr", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"021155724", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Children's Hosp of Boston", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"02118", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Boston City Hosp / Pediatrics", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"01199", "city"=>"Springfield", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Baystate Med Ctr of Springfield", "geoPoint"=>{"lat"=>42.10148, "lon"=>-72.58981}}, {"zip"=>"016550001", "city"=>"Worcester", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Univ of Massachusetts Med School", "geoPoint"=>{"lat"=>42.26259, "lon"=>-71.80229}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Children's Hosp of Michigan", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"39213", "city"=>"Jackson", "state"=>"Mississippi", "country"=>"United States", "facility"=>"Univ of Mississippi Med Ctr", "geoPoint"=>{"lat"=>32.29876, "lon"=>-90.18481}}, {"zip"=>"089030019", "city"=>"New Brunswick", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - Robert Wood Johnson Med School / Pediatrics", "geoPoint"=>{"lat"=>40.48622, "lon"=>-74.45182}}, {"zip"=>"071032714", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Univ of Medicine & Dentistry of New Jersey / Univ Hosp", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"10461", "city"=>"Bronx", "state"=>"New York", "country"=>"United States", "facility"=>"Bronx Municipal Hosp Ctr/Jacobi Med Ctr", "geoPoint"=>{"lat"=>40.84985, "lon"=>-73.86641}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY - Brooklyn", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"11021", "city"=>"Great Neck", "state"=>"New York", "country"=>"United States", "facility"=>"North Shore Univ Hosp", "geoPoint"=>{"lat"=>40.80066, "lon"=>-73.72846}}, {"zip"=>"11040", "city"=>"New Hyde Park", "state"=>"New York", "country"=>"United States", "facility"=>"Schneider Children's Hosp", "geoPoint"=>{"lat"=>40.7351, "lon"=>-73.68791}}, {"zip"=>"10016", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Bellevue Hosp / New York Univ Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Metropolitan Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia Presbyterian Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"146420001", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ of Rochester Med Ctr", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"117948111", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"State Univ of New York at Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"277103499", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ Med Ctr", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"432052696", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Columbus Children's Hosp", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"191044318", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Children's Hosp of Philadelphia", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"294253312", "city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Med Univ of South Carolina", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}, {"zip"=>"23219", "city"=>"Richmond", "state"=>"Virginia", "country"=>"United States", "facility"=>"Med College of Virginia", "geoPoint"=>{"lat"=>37.55376, "lon"=>-77.46026}}, {"zip"=>"981050371", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Children's Hospital & Medical Center / Seattle ACTU", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"zip"=>"00956", "city"=>"Bayamon", "country"=>"Puerto Rico", "facility"=>"Ramon Ruiz Arnau Univ Hosp / Pediatrics", "geoPoint"=>{"lat"=>18.39856, "lon"=>-66.15572}}, {"zip"=>"009365067", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Univ of Puerto Rico / Univ Children's Hosp AIDS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"zip"=>"009367344", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"Wayne Dankner", "role"=>"STUDY_CHAIR"}, {"name"=>"Ram Yogev", "role"=>"STUDY_CHAIR"}, {"name"=>"Walter Hughes", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)", "class"=>"NIH"}]}}}
