Nctid:
NCT00001077
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000019247", "term"=>"HIV Wasting Syndrome"}, {"id"=>"D000019282", "term"=>"Wasting Syndrome"}, {"id"=>"D000015431", "term"=>"Weight Loss"}, {"id"=>"D000002100", "term"=>"Cachexia"}], "ancestors"=>[{"id"=>"D000015658", "term"=>"HIV Infections"}, {"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"}, {"id"=>"D000001836", "term"=>"Body Weight Changes"}, {"id"=>"D000001835", "term"=>"Body Weight"}, {"id"=>"D000013851", "term"=>"Thinness"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5363", "name"=>"Cachexia", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18102", "name"=>"Weight Loss", "asFound"=>"Weight Loss", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M21232", "name"=>"HIV Wasting Syndrome", "asFound"=>"HIV Wasting Syndrome", "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"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M5115", "name"=>"Body Weight Changes", "relevance"=>"LOW"}, {"id"=>"M16614", "name"=>"Thinness", "relevance"=>"LOW"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"Blood collection"}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>536}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2013-09", "completionDateStruct"=>{"date"=>"1998-04", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2013-09-28", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2013-10-01", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1998-04", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Weight Loss", "Acquired Immunodeficiency Syndrome", "Nutritional Support"], "conditions"=>["HIV Infections", "HIV Wasting Syndrome"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Gibert CL, Muurahainen N, Collins G, Williams B, Raghavan S, Bartsch G, Wheeler D. Body composition in HIV-infected men and women in 1996-1997 (CPCRA 038). Int Conf AIDS. 1998;12:554 (abstract no 32169)"}, {"type"=>"BACKGROUND", "citation"=>"Williams SB, Collins G, Muurahainen N, Bartsch G, Gibert C, Raghavan SS, Wheeler D. Protein intake is associated with body cell mass in weight-stable HIV+ men with CD4 < 200 cells/mm3: CPCRA 038. Int Conf AIDS. 1998;12:841-2 (abstract no 42339)"}, {"pmid"=>"9625392", "type"=>"BACKGROUND", "citation"=>"Muurahainen N, Mulligan K. Clinical trials update in human immunodeficiency virus wasting. Semin Oncol. 1998 Apr;25(2 Suppl 6):104-11."}, {"type"=>"BACKGROUND", "citation"=>"Muurahainen N, Collins G, Wheeler D, Mateo N, Madans M, Bartsch G, Gilbert C. Body cell mass (BCM) in HIV-infected (HIV+) males in the community programs for clinical research on AIDS (CPCRA) in 1996-1997. Int Conf AIDS. 1998;12:840 (abstract no 42333)"}, {"pmid"=>"10770345", "type"=>"BACKGROUND", "citation"=>"Gibert CL, Wheeler DA, Collins G, Madans M, Muurahainen N, Raghavan SS, Bartsch G. Randomized, controlled trial of caloric supplements in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):253-9. doi: 10.1097/00126334-199911010-00006."}]}, "descriptionModule"=>{"briefSummary"=>"To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement.", "detailedDescription"=>"Patients will be randomized to one of 3 study arms:\n\nArm 1 - Peptamen drinks + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 2 - NuBasics drinks or equivalent amounts of NuBasics soups or bars + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 3 - Multivitamin and mineral supplement, taken in addition to regular diet for 4 months.\n\nAt months 0, 2, and 4, patients will be assessed for weight, body cell mass, patient-reported physical activity level, and dietary intake (by 24-hour dietary recall). At months 2 and 4, they will also be assessed for compliance with study regimen. Patients who complete their 4 month follow up visit will be provided with a 30 day supply of the caloric supplement of their choice (Peptamen or NuBasics) and a 30 day supply of the study multivitamin supplement."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"HIV-infected participants who take a daily multivitamin and mineral supplement", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV infection.\n* Stable weight.\n* CD4+ cell count \\<200 cells/mm3.\n* Life expectancy of at least 6 months.\n* Parent or legal guardian to sign written, informed consent for patients \\< 18 years old.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with any of the following symptoms or conditions are excluded:\n\n* Active opportunistic infection, requiring acute treatment.\n* Malignancy (other than stable cutaneous Kaposi's sarcoma that does not require systemic chemotherapy).\n* Diabetes mellitus or other conditions requiring special dietary restrictions.\n* Body mass index (BMI) \\>= 29.0 kg/m2.\n* Disorders or conditions that, in the treating clinician's opinion, may prevent adequate compliance with protocol requirements.\n\nConcurrent Medication:\n\nExcluded:\n\n* Growth hormone.\n* Megestrol acetate (Megace).\n* Cyproheptadine (Periactin).\n* Dronabinol (Marinol).\n* Thalidomide.\n* Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin).\n* Pharmacologic-dose corticosteroids (e.g., \\> 15 mg/day prednisone equivalent)\n\nNOTE:\n\n* Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled.\n* Caloric nutritional supplements deemed by the clinician to promote weight gain or maintenance.\n\nPatients with the following prior condition are excluded:\n\n* History of phenylketonuria.\n\nPrior Medication:\n\nExcluded within the past 2 weeks:\n\n* Use of caloric nutritional supplements for more than 5 days deemed by the clinician to promote weight gain or maintenance.\n\nExcluded within the past 30 days:\n\n* Growth hormone.\n* Megestrol acetate (Megace).\n* Cyproheptadine (Periactin).\n* Dronabinol (Marinol).\n* Thalidomide.\n* Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin)\n* Pharmacologic-dose corticosteroids (e.g., \\> 15 mg/day prednisone equivalent).\n\nNOTE:\n\n* Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled."}, "identificationModule"=>{"nctId"=>"NCT00001077", "briefTitle"=>"A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"An Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement", "orgStudyIdInfo"=>{"id"=>"CPCRA 038"}, "secondaryIdInfos"=>[{"id"=>"11588", "type"=>"REGISTRY", "domain"=>"DAIDS ES"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"1", "description"=>"Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months", "interventionNames"=>["Dietary Supplement: Multivitamin and mineral supplements", "Dietary Supplement: Peptamen"]}, {"label"=>"2", "description"=>"Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months", "interventionNames"=>["Dietary Supplement: Multivitamin and mineral supplements", "Dietary Supplement: NuBasics"]}, {"label"=>"3", "description"=>"Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months", "interventionNames"=>["Dietary Supplement: Multivitamin and mineral supplements"]}], "interventions"=>[{"name"=>"Multivitamin and mineral supplements", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Oral tablets taken daily", "armGroupLabels"=>["1", "2", "3"]}, {"name"=>"Peptamen", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Solution received daily", "armGroupLabels"=>["1"]}, {"name"=>"NuBasics", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Solution or dietary bar received daily", "armGroupLabels"=>["2"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Community Consortium / UCSF", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80204", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Denver CPCRA / Denver Public Hlth", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"20422", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Washington Reg AIDS Prog / Dept of Infect Dis", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"30308", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"AIDS Research Consortium of Atlanta", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian - Saint Luke's Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60657", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"AIDS Research Alliance - Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Louisiana Comm AIDS Rsch Prog / Tulane Univ Med", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21201", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Baltimore Trials", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Wayne State Univ / WSU / DMC HIV / AIDS Program", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"48202", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Henry Ford Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"08103", "city"=>"Camden", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Southern New Jersey AIDS Cln Trials / Dept of Med", "geoPoint"=>{"lat"=>39.92595, "lon"=>-75.11962}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"North Jersey Community Research Initiative", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"87131", "city"=>"Albuquerque", "state"=>"New Mexico", "country"=>"United States", "facility"=>"Partners in Research - New Mexico", "geoPoint"=>{"lat"=>35.08449, "lon"=>-106.65114}}, {"zip"=>"87131", "city"=>"Albuquerque", "state"=>"New Mexico", "country"=>"United States", "facility"=>"Partners Research", "geoPoint"=>{"lat"=>35.08449, "lon"=>-106.65114}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem AIDS Treatment Group / Harlem Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Philadelphia FIGHT", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}], "overallOfficials"=>[{"name"=>"Gilbert CL", "role"=>"STUDY_CHAIR"}, {"name"=>"Wheeler D", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
