Nctid:
NCT00000854
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-27"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019247", "term"=>"HIV Wasting Syndrome"}, {"id"=>"D019282", "term"=>"Wasting Syndrome"}, {"id"=>"D013577", "term"=>"Syndrome"}, {"id"=>"D015431", "term"=>"Weight Loss"}, {"id"=>"D002100", "term"=>"Cachexia"}], "ancestors"=>[{"id"=>"D004194", "term"=>"Disease"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"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"}, {"id"=>"D001836", "term"=>"Body Weight Changes"}, {"id"=>"D001835", "term"=>"Body Weight"}, {"id"=>"D013851", "term"=>"Thinness"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}, {"id"=>"D009748", "term"=>"Nutrition Disorders"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18102", "name"=>"Weight Loss", "asFound"=>"Weight Loss", "relevance"=>"HIGH"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5363", "name"=>"Cachexia", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M21232", "name"=>"HIV Wasting Syndrome", "asFound"=>"HIV Wasting Syndrome", "relevance"=>"HIGH"}, {"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"=>"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"=>"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"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000077603", "term"=>"Nandrolone Decanoate"}, {"id"=>"D009277", "term"=>"Nandrolone"}, {"id"=>"C008580", "term"=>"Nandrolone phenpropionate"}], "ancestors"=>[{"id"=>"D000728", "term"=>"Androgens"}, {"id"=>"D006728", "term"=>"Hormones"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D045930", "term"=>"Anabolic Agents"}, {"id"=>"D050071", "term"=>"Bone Density Conservation Agents"}], "browseLeaves"=>[{"id"=>"M1859", "name"=>"Nandrolone Decanoate", "asFound"=>"Seventy", "relevance"=>"HIGH"}, {"id"=>"M12228", "name"=>"Nandrolone", "asFound"=>"MPM", "relevance"=>"HIGH"}, {"id"=>"M241168", "name"=>"Nandrolone phenpropionate", "asFound"=>"Seventy", "relevance"=>"HIGH"}, {"id"=>"M3032", "name"=>"Anabolic Androgenic Steroids", "relevance"=>"LOW"}, {"id"=>"M4059", "name"=>"Androgens", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M25605", "name"=>"Anabolic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>38}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"2003-05", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2021-10-27", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2021-10-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Placebos", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "Anabolic Steroids", "HIV Wasting Syndrome", "nandrolone decanoate"], "conditions"=>["HIV Infections", "HIV Wasting Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"15767536", "type"=>"BACKGROUND", "citation"=>"Mulligan K, Zackin R, Clark RA, Alston-Smith B, Liu T, Sattler FR, Delvers TB, Currier JS; AIDS Clinical Trials Group 329 Study Team; National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group. Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial. Arch Intern Med. 2005 Mar 14;165(5):578-85. doi: 10.1001/archinte.165.5.578."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting).\n\nWasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.", "detailedDescription"=>"Body wasting is an increasingly frequent AIDS-defining condition and it is becoming evident that women are not exempt from this complication of HIV. Although multicenter trials of megestrol acetate, dronabinol and growth hormone have not specifically excluded women, women have generally been underrepresented in these trials. This study hopes to generate data that will be substantial enough to perform an analysis that might determine whether there are gender-based differences in anabolic potential.\n\nPatients will be randomized to receive either nandrolone decanoate or placebo every 2 weeks for 12 weeks of the study. All patients who complete the first 12 weeks of the study will be eligible to receive open-label nandrolone for the subsequent 12 weeks."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nYou may be eligible for this study if you:\n\n* Are an HIV-positive woman over 13 years old (need consent if under 18).\n* Have lost weight over the past 12 months.\n* Are able to eat almost enough to maintain your current weight.\n* Agree to practice abstinence or use effective methods of birth control.\n* Are on a stable anti-HIV drug regimen or have not been on any anti-HIV drug regimen for the past 30 days.\n\nExclusion Criteria\n\nYou will not be eligible for this study if you:\n\n* Are allergic to nandrolone.\n* Have a history of cervical cancer, diabetes, cardiomyopathy or congestive heart failure, or are taking certain medications.\n* Have an active opportunistic (HIV-associated) infection or another major illness within 30 days of study entry.\n* Have an abnormal PAP smear.\n* Have difficulty eating (are on tube-feeding, for example).\n* Have severe nausea, vomiting, or diarrhea.\n* Have Kaposi's sarcoma (unless stable) or are receiving chemotherapy or radiation for any type of cancer.\n* Are pregnant or breast-feeding."}, "identificationModule"=>{"nctId"=>"NCT00000854", "briefTitle"=>"A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Trial of Nandrolone Decanoate in Women With HIV-Associated Weight Loss", "orgStudyIdInfo"=>{"id"=>"ACTG 329"}, "secondaryIdInfos"=>[{"id"=>"11301", "type"=>"REGISTRY", "domain"=>"DAIDS ES"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Nandrolone decanoate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"USC CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90035", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"UCLA CARE Center CRS", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92103", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"Ucsd, Avrc Crs", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Ucsf Aids Crs", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80045", "city"=>"Aurora", "state"=>"Colorado", "country"=>"United States", "facility"=>"University of Colorado Hospital CRS", "geoPoint"=>{"lat"=>39.72943, "lon"=>-104.83192}}, {"zip"=>"20060", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Howard University Hosp., Div. of Infectious Diseases, ACTU", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"96813", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Queens Med. Ctr.", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Univ. of Hawaii at Manoa, Leahi Hosp.", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern University CRS", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Adult AIDS CRS", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess Med. Ctr., ACTG CRS", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"63110", "city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington U CRS", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"63112", "city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"St. Louis ConnectCare, Infectious Diseases Clinic", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"10003", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Beth Israel Med. Ctr. (Mt. Sinai)", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"14642", "city"=>"Rochester", "state"=>"New York", "country"=>"United States", "facility"=>"Univ. of Rochester ACTG CRS", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"27514", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Unc Aids Crs", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ. Med. Ctr. Adult CRS", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"45267", "city"=>"Cincinnati", "state"=>"Ohio", "country"=>"United States", "facility"=>"Univ. of Cincinnati CRS", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Hosp. of the Univ. of Pennsylvania CRS", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"00935", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"Puerto Rico-AIDS CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}, {"zip"=>"00936", "city"=>"San Juan", "country"=>"Puerto Rico", "facility"=>"San Juan City Hosp. PR NICHD CRS", "geoPoint"=>{"lat"=>18.46633, "lon"=>-66.10572}}], "overallOfficials"=>[{"name"=>"K Mulligan", "role"=>"STUDY_CHAIR"}, {"name"=>"R Clark", "role"=>"STUDY_CHAIR"}, {"name"=>"J Currier", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
