Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) [clinicaltrials:NCT00294164]

Bio2RDF uri

Safety and Efficacy Trial of Serostim® in the Treatment of Subjects With Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS) [clinicaltrials:NCT00294164]

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]

http://bio2rdf.org/clinicaltrials:NCT00294164

Bio2RDF identifier

NCT00294164

http://www.w3.org/2001/XMLSchema#string

Bio2RDF namespace

clinicaltrials

http://www.w3.org/2001/XMLSchema#string

Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT00294164

http://www.w3.org/2001/XMLSchema#string

identifiers.org URI

NCT00294164

actual enrollment [clinicaltrials_vocabulary:actual-enrollment]

245

http://www.w3.org/2001/XMLSchema#integer

arm group [clinicaltrials_vocabulary:arm-group]

NCT00294164 arm group 179e032ba30d365d7b033a7903831c5d [clinicaltrials_resource:NCT00294164/arm-group/179e032ba30d365d7b033a7903831c5d]

NCT00294164 arm group 6f8ce038bc50a5372fcaf86e4b300bb6 [clinicaltrials_resource:NCT00294164/arm-group/6f8ce038bc50a5372fcaf86e4b300bb6]

NCT00294164 arm group 9fe6ee03829636e921397d29b994975a [clinicaltrials_resource:NCT00294164/arm-group/9fe6ee03829636e921397d29b994975a]

authority [clinicaltrials_vocabulary:authority]

clinicaltrials_resource:d942c8692d257084abf3ac87279faff6

brief summary [clinicaltrials_vocabulary:brief-summary]

This study is a Phase 2 ...... col (Study 23056) at Week 24.

http://www.w3.org/2001/XMLSchema#string

brief title [clinicaltrials_vocabulary:brief-title]

Safety and Efficacy Trial of S ...... Redistribution Syndrome (HARS)

http://www.w3.org/2001/XMLSchema#string

clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:671a74468188ef7036e753ae35c949b9]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:d5317f095890e5905c861714cd1c95f1]

clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:0219679de2a6c68779487f3f3e4da4ca]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:096c104b331fdb4cda250aaf02ad084a]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:101e9199ed0c113a7d6b22da4b6846d8]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:2984f677d864e7333aea41f41c9a6a8c]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:36c4ac8fdd039696d95e22867725d7d9]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:3fe0c9d9fe647d2e90a11368e3a7c612]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:43197a22f6d2a8ff288c068695cada76]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:4ecab6fdf49c694913139648f3632e72]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:531c9bf0ccc3eddf64f279da3f4a4e44]

Change from Baseline in absolute area of visceral adipose tissue quantified by Computerized Tomography (CT) scan at Week 12 Baseline and Week 12 [clinicaltrials_resource:787c68228fd880c71e753df430e475c3]

completion date [clinicaltrials_vocabulary:completion-date]

2002-05-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

http://www.w3.org/2001/XMLSchema#string

eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT00294164 [clinicaltrials_resource:02d42a185910a2eb6b8e960cab1fe831]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2006-02-16T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

has expanded access [clinicaltrials_vocabulary:has-expanded-access]

http://www.w3.org/2001/XMLSchema#string

intervention [clinicaltrials_vocabulary:intervention]

Serostim® [clinicaltrials_resource:3ac37aef162f2f88a8a53afa1f48e103]

Placebo [clinicaltrials_resource:793b04cf75ef04dbfb147b3214c8f38c]

intervention browse [clinicaltrials_vocabulary:intervention-browse]

Hormones [clinicaltrials_resource:6a0950f2cec875d2724380d264d5d373]

is fda regulated [clinicaltrials_vocabulary:is-fda-regulated]

Yes

http://www.w3.org/2001/XMLSchema#string

is section 801 [clinicaltrials_vocabulary:is-section-801]

http://www.w3.org/2001/XMLSchema#string

keyword [clinicaltrials_vocabulary:keyword]

Human Immunodeficiency Virus Infections

http://www.w3.org/2001/XMLSchema#string

Human Immunodeficiency Virus-associated Adipose Redistribution Syndrome (HARS)

http://www.w3.org/2001/XMLSchema#string

Placebo

http://www.w3.org/2001/XMLSchema#string

Serostim®

http://www.w3.org/2001/XMLSchema#string

recombinant human growth hormone (r-hGH)

http://www.w3.org/2001/XMLSchema#string

lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2014-03-24T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

EMD Serono [clinicaltrials_resource:b2b1c91cbcef15ce75de6ad897745af7]

link [clinicaltrials_vocabulary:link]

Full FDA approved prescribing information can be found here [clinicaltrials_resource:b20d8bd7f838b746c79c5a58cf90a3f2]

Published in J Acquir Immune Defic Syndr 35; 239-252: 2004 [clinicaltrials_resource:dcf5a34ea817dbc74c8a2624047334a4]

nct id [clinicaltrials_vocabulary:nct-id]

NCT00294164

http://www.w3.org/2001/XMLSchema#string

number of arms [clinicaltrials_vocabulary:number-of-arms]

http://www.w3.org/2001/XMLSchema#integer

official title [clinicaltrials_vocabulary:official-title]

Phase 2/3, Multicenter, Double ...... Redistribution Syndrome (HARS)

http://www.w3.org/2001/XMLSchema#string

org study id [clinicaltrials_vocabulary:org-study-id]

22,388

http://www.w3.org/2001/XMLSchema#integer

overall official [clinicaltrials_vocabulary:overall-official]

Ellen Brady, M.D. MPH [clinicaltrials_resource:bd7d5702c19bfd627755c12334daf03d]

overall status [clinicaltrials_vocabulary:overall-status]

Completed [clinicaltrials_resource:07ca5050e697392c9ed47e6453f1453f]

oversight [clinicaltrials_vocabulary:oversight]

United States: Food and Drug Administration [clinicaltrials_resource:77fa11db9aea1d8cd0ff35db5bc538f2]

phase [clinicaltrials_vocabulary:phase]

Phase 2/Phase 3 [clinicaltrials_resource:d4235ce98efbb8b69dded131ccb7fa52]

primary completion date [clinicaltrials_vocabulary:primary-completion-date]

2002-05-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

source [clinicaltrials_vocabulary:source]

EMD Serono [clinicaltrials_resource:b2b1c91cbcef15ce75de6ad897745af7]

start date [clinicaltrials_vocabulary:start-date]

2001-03-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT00294164 study design [clinicaltrials_resource:bbff1cbfc6cc2d4f97beeaec4ee8879a]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT00294164

verification date [clinicaltrials_vocabulary:verification-date]

2014-03-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

identifier

clinicaltrials:NCT00294164

http://www.w3.org/2001/XMLSchema#string

title

Safety and Efficacy Trial of S ...... Redistribution Syndrome (HARS)

@en

inDataset

clinicaltrials_resource:bio2rdf.dataset.clinicaltrials.R3

type

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]

label

Safety and Efficacy Trial of S ...... ) [clinicaltrials:NCT00294164]

@en