Nctid:
NCT00001079
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019247", "term"=>"HIV Wasting Syndrome"}, {"id"=>"D019282", "term"=>"Wasting Syndrome"}, {"id"=>"D013577", "term"=>"Syndrome"}, {"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"=>"D015431", "term"=>"Weight Loss"}, {"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"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M18102", "name"=>"Weight Loss", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "asFound"=>"Syndrome", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M21265", "name"=>"Wasting Syndrome", "asFound"=>"Wasting Syndrome", "relevance"=>"HIGH"}, {"id"=>"M5363", "name"=>"Cachexia", "asFound"=>"Wasting", "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"=>"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"=>"D008777", "term"=>"Methyltestosterone"}, {"id"=>"D008535", "term"=>"Megestrol"}, {"id"=>"D019290", "term"=>"Megestrol Acetate"}, {"id"=>"D013739", "term"=>"Testosterone"}, {"id"=>"C010792", "term"=>"Testosterone undecanoate"}, {"id"=>"C004648", "term"=>"Testosterone enanthate"}, {"id"=>"C016131", "term"=>"Testosterone 17 beta-cypionate"}], "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"=>"D018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D045930", "term"=>"Anabolic Agents"}, {"id"=>"D003278", "term"=>"Contraceptives, Oral, Hormonal"}, {"id"=>"D003276", "term"=>"Contraceptives, Oral"}, {"id"=>"D003271", "term"=>"Contraceptive Agents, Female"}, {"id"=>"D003270", "term"=>"Contraceptive Agents"}, {"id"=>"D012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D000080066", "term"=>"Contraceptive Agents, Hormonal"}, {"id"=>"D003280", "term"=>"Contraceptives, Oral, Synthetic"}, {"id"=>"D019167", "term"=>"Appetite Stimulants"}, {"id"=>"D000697", "term"=>"Central Nervous System Stimulants"}], "browseLeaves"=>[{"id"=>"M11751", "name"=>"Methyltestosterone", "asFound"=>"During sleep", "relevance"=>"HIGH"}, {"id"=>"M16509", "name"=>"Testosterone", "asFound"=>"Mechanical", "relevance"=>"HIGH"}, {"id"=>"M223475", "name"=>"Testosterone undecanoate", "asFound"=>"During sleep", "relevance"=>"HIGH"}, {"id"=>"M223485", "name"=>"Testosterone enanthate", "asFound"=>"During sleep", "relevance"=>"HIGH"}, {"id"=>"M235012", "name"=>"Testosterone 17 beta-cypionate", "asFound"=>"During sleep", "relevance"=>"HIGH"}, {"id"=>"M11518", "name"=>"Megestrol", "asFound"=>"Bolus dose", "relevance"=>"HIGH"}, {"id"=>"M21272", "name"=>"Megestrol Acetate", "asFound"=>"Satiety", "relevance"=>"HIGH"}, {"id"=>"M15989", "name"=>"Dihydrotestosterone", "relevance"=>"LOW"}, {"id"=>"M4059", "name"=>"Androgens", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M3032", "name"=>"Anabolic Androgenic Steroids", "relevance"=>"LOW"}, {"id"=>"M25605", "name"=>"Anabolic Agents", "relevance"=>"LOW"}, {"id"=>"M6494", "name"=>"Contraceptive Agents", "relevance"=>"LOW"}, {"id"=>"M6500", "name"=>"Contraceptives, Oral", "relevance"=>"LOW"}, {"id"=>"M6502", "name"=>"Contraceptives, Oral, Hormonal", "relevance"=>"LOW"}, {"id"=>"M6495", "name"=>"Contraceptive Agents, Female", "relevance"=>"LOW"}, {"id"=>"M2116", "name"=>"Contraceptive Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M4029", "name"=>"Central Nervous System Stimulants", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"Central Nervous System Stimulants", "abbrev"=>"CNSSti"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>80}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-10", "completionDateStruct"=>{"date"=>"2002-12", "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"=>["Placebos", "Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "AIDS-Related Complex", "HIV Wasting Syndrome", "Megestrol Acetate", "dihydrotestosterone heptanoate"], "conditions"=>["HIV Infections", "HIV Wasting Syndrome"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Schambelan M, Zackin R, Mulligan K, Sattler FR, Chesney M, Stevens M, Edwards L, Egorin MJ, Von Roenn JH. Effect of testosterone (T) on the response to megesterol acetate (MA) in patients with HIV-associated wasting: a randomized, double-blind placebo-controlled trial (ACTG 313). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 640)"}]}, "descriptionModule"=>{"briefSummary"=>"To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination.\n\nBody wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.", "detailedDescription"=>"Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.\n\nThis is a 24 week study consisting of a 12 week double blind, randomized comparison Phase II trial of megestrol acetate and testosterone enanthate in combination versus megestrol acetate plus testosterone enanthate placebo in HIV associated wasting and a 12 week open label follow up of the combination therapy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Stable antiretroviral therapy provided the patient has been on it for \\>=30 days prior to study entry. AS PER AMENDMENT 9/26/97: Optimized antiretroviral therapy as determined by primary care provider with at least 30 days since initiation of such therapy.\n* Standard maintenance and prophylaxis therapy for opportunistic infections is permitted provided patients have been on a stable dosage regimen for 2 weeks prior to screening.\n* G-CSF.\n* Erythropoietin.\n* Any symptomatic therapy (e.g., analgesics, antihistamines, antiemetic, antidiarrheal agents, etc.).\n* Replacement levels of thyroid drugs (same drug and dose as at 30 days pre-entry).\n* Maintenance therapy is permitted for chronic opportunistic infections, but patient must be on a stable regimen for 14 days pre-entry.\n* AS PER AMENDMENT 9/26/97: Oral nutritional supplements, dronabinol, cyproheptadine, or pentoxifylline.\n\nPatients must have:\n\n* Documented HIV-1 infection.\n* Documented weight loss of \\> 10% pre-illness weight or Body Mass Index \\< 18.5 kg/m2. AS PER AMENDMENT 9/26/97: Documented weight loss of \\>= 5% pre-illness weight or Body Mass Index \\< 20 kg/m2.\n* Life expectancy of at least 6 months.\n\nNOTE:\n\n* This protocol meets federal requirements governing prisoner participation in clinical trials.\n\nPrior Medication:\n\nAllowed:\n\n* Stable (no change in drugs or dosage) antiretroviral therapy or no antiretroviral medications for \\>= 30 days prior to the study entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with any of the following symptoms or conditions are excluded:\n\n* Diabetes mellitus.\n* Diarrhea defined as 4 or more liquid or watery stools per day while using antidiarrheal medication.\n* Tube feeding. AS PER AMENDMENT 9/26/97: Total or partial parenteral nutrition delivered centrally or peripherally.\n* Impaired oral intake due to mucositis of any cause.\n* Grade 2 or greater intractable nausea and vomiting despite medication.\n* Cardiomyopathy or congestive heart failure.\n* Persistent palpable dominant breast mass at study entry that has not been worked up - males and females.\n\nFemale patients:\n\n* Pap smear or cervical biopsy that demonstrates high grade squamous intraepithelial lesions or cervical intraepithelial lesions 2 or worse.\n\nConcurrent Medication:\n\nExcluded:\n\n* Systemic chemotherapy for B-cell lymphoma or malignancies other than Kaposi's sarcoma. (Patients with Kaposi's sarcoma receiving systemic chemotherapy will not be excluded.)\n* Total or peripheral parenteral nutrition (oral supplements are not excluded).\n* Anticoagulant therapy.\n* Any drug that is designed to affect appetite or weight gain. AS PER AMENDMENT 9/26/97: Initiation of any new therapy designed to promote weight gain.\n* Any change of antiretroviral or any change in the dosage of antiretroviral/s that had not been started 30 days pre-entry. AS PER AMENDMENT 9/26/97: Initiation of antiretroviral therapy within 12 weeks of protocol therapy for patients not previously receiving antiretroviral therapy.\n* Anabolic hormones.\n* Systemic glucocorticoids.\n* Cytokine inhibitors.\n* Oral contraceptives.\n* Cytokines.\n* Ketoconazole.\n* Any other medication that might interfere with the objectives of this study.\n* AS PER AMENDMENT 9/26/97:DHEA.\n\nPatients with the following prior conditions will be excluded:\n\n* Acute systemic opportunistic infections within 30 days prior to entry.\n* Weight gain \\>= 3% as documented by self reporting or clinical records during the preceding 4 weeks. AS PER AMENDMENT 9/26/97: Enrollment of such patients should be deferred until weight stabilizes.\n* History of hypersensitivity reaction to megestrol acetate or testosterone enanthate.\n* History of cardiomyopathy or congestive heart failure.\n\nFemale patients:\n\n* History of invasive cervical cancer.\n* AS PER AMENDMENT 9/26/97: History of thromboemboli.\n\nPrior Medication:\n\nExcluded:\n\n* No testosterone treatment within the previous 8 weeks.\n\nExcluded within 30 days prior to entry:\n\n* Ketoconazole.\n* Initiation or change in antiretroviral therapy.\n* Interleukins.\n* Interferon, anabolic, hormonal or experimental therapies designed to improve appetite or weight gain (e.g., thalidomide, dronabinol, megestrol acetate, cyproheptadine, anabolic steroids, systemic glucocorticoids, pentoxifylline, or growth hormone).\n* AS PER AMENDMENT 9/26/97: Dehydroepiandrosterone (DHEA)."}, "identificationModule"=>{"nctId"=>"NCT00001079", "briefTitle"=>"A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "officialTitle"=>"Double-Blind Randomized Comparison Phase II Trial of Megestrol Acetate and Testosterone Enanthate in Combination Versus Megestrol Acetate Plus Testosterone Enanthate Placebo in Human Immunodeficiency Virus (HIV)-Associated Wasting.", "orgStudyIdInfo"=>{"id"=>"ACTG 313"}, "secondaryIdInfos"=>[{"id"=>"11288", "type"=>"REGISTRY", "domain"=>"DAIDS ES"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Testosterone enanthate", "type"=>"DRUG"}, {"name"=>"Megestrol acetate", "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"=>"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"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Infectious Disease Research Clinic", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ. School of Medicine, Wishard Memorial", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"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}}, {"city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"St. Louis ConnectCare, Infectious Diseases Clinic", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"city"=>"Saint Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Washington U CRS", "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"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Cornell University A2201", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10021", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Memorial Sloan-Kettering Cancer Ctr.", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ. Med. Ctr. Adult CRS", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"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}}], "overallOfficials"=>[{"name"=>"Schambelan M", "role"=>"STUDY_CHAIR"}, {"name"=>"Mulligan K", "role"=>"STUDY_CHAIR"}, {"name"=>"Von Roenn JH", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
