Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT00069004
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2003-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D039682', 'term': 'HIV-Associated Lipodystrophy Syndrome'}, {'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'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': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2003-09-12', 'studyFirstSubmitQcDate': '2003-09-15', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HIV-Associated Lipodystrophy Syndrome', 'HIV Lipodystrophy Syndrome', 'Treatment Experienced', 'Lipodystrophy', 'Dyslipidemia', 'Osteoporosis', 'Osteopenia'], 'conditions': ['HIV Infections', 'HIV-Associated Lipodystrophy Syndrome', 'HIV Lipodystrophy Syndrome', 'Lipodystrophy', 'Dyslipidemia', 'Osteoporosis', 'Osteopenia']}, 'referencesModule': {'references': [{'pmid': '11740715', 'type': 'BACKGROUND', 'citation': 'Wanke CA, Falutz JM, Shevitz A, Phair JP, Kotler DP. Clinical evaluation and management of metabolic and morphologic abnormalities associated with human immunodeficiency virus. Clin Infect Dis. 2002 Jan 15;34(2):248-59. doi: 10.1086/324744. Epub 2001 Dec 7.'}, {'pmid': '12001033', 'type': 'BACKGROUND', 'citation': 'Smith KY. Selected metabolic and morphologic complications associated with highly active antiretroviral therapy. J Infect Dis. 2002 May 15;185 Suppl 2:S123-7. doi: 10.1086/340200.'}, {'pmid': '11966241', 'type': 'BACKGROUND', 'citation': 'Currier J, Carpenter C, Daar E, Kotler D, Wanke C. Identifying and managing morphologic complications of HIV and HAART. AIDS Read. 2002 Mar;12(3):114-9, 124-5.'}, {'pmid': '10382692', 'type': 'BACKGROUND', 'citation': 'Carr A, Samaras K, Thorisdottir A, Kaufmann GR, Chisholm DJ, Cooper DA. Diagnosis, prediction, and natural course of HIV-1 protease-inhibitor-associated lipodystrophy, hyperlipidaemia, and diabetes mellitus: a cohort study. Lancet. 1999 Jun 19;353(9170):2093-9. doi: 10.1016/S0140-6736(98)08468-2.'}, {'pmid': '12797313', 'type': 'BACKGROUND', 'citation': 'Bockhorst JL, Ksseiry I, Toye M, Chipkin SR, Stechenberg BW, Fisher DJ, Allen HF. Evidence of human immunodeficiency virus-associated lipodystrophy syndrome in children treated with protease inhibitors. Pediatr Infect Dis J. 2003 May;22(5):463-5.'}, {'pmid': '10770534', 'type': 'BACKGROUND', 'citation': 'Tebas P, Powderly WG, Claxton S, Marin D, Tantisiriwat W, Teitelbaum SL, Yarasheski KE. Accelerated bone mineral loss in HIV-infected patients receiving potent antiretroviral therapy. AIDS. 2000 Mar 10;14(4):F63-7. doi: 10.1097/00002030-200003100-00005.'}, {'pmid': '20168204', 'type': 'RESULT', 'citation': 'Jacobson DL, Lindsey JC, Gordon CM, Moye J, Hardin DS, Mulligan K, Aldrovandi GM; Pediatric AIDS Clinical Trials Group P1045 team. Total body and spinal bone mineral density across Tanner stage in perinatally HIV-infected and uninfected children and youth in PACTG 1045. AIDS. 2010 Mar 13;24(5):687-96. doi: 10.1097/QAD.0b013e328336095d.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the prevalence of metabolic and physical abnormalities in HIV infected (via mother-to-child transmission) and uninfected children and youth. Metabolism, body composition, bone density, and other factors will be assessed in relationship to participants' exposure to highly active antiretroviral therapy (HAART).", 'detailedDescription': 'Despite advances in HIV care associated with HAART, many patients on HAART regimens develop physical and metabolic problems, including changes in body fat distribution (lipodystrophy), osteopenia and osteoporosis, dyslipidemia, and hyperlactatemia. Early studies suggest that protease inhibitors (PIs) were directly responsible for HIV Lipodystrophy Syndrome (HLS) and skeletal complications in HAART-treated patients. This study will compare HIV infected, HAART-treated children and youth and their uninfected counterparts to make connections between HAART, HLS, and skeletal and metabolic problems. The study is the first to address the prevalence and risk assessment of these complications in children, and will be useful in predicting long-term prognosis in HIV patients who use or have used HAART.\n\nThere will be three groups in the study. Group 1 participants will be uninfected volunteers who will receive no protocol-specific treatment or other intervention. Vertically infected HIV patients in Groups 2 and 3 will continue their current HAART either on a non-PI-containing regimen (Group 2) or a PI-containing regimen (Group 3). Screening evaluations will be conducted within 30 days prior to study entry. Study evaluations may be completed at study entry or over the course of up to 3 study visits. All participants will undergo whole body and regional DEXA scans (to assess bone density), measurements to determine sexual maturity, and blood work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nFor HIV uninfected participants (Group 1)\n\n* HIV-1 negative (perinatally HIV-exposed but uninfected participants are eligible)\n\nFor HIV infected participants (Groups 2 and 3)\n\n* Mother-to-child (vertically) transmitted HIV infection\n* Confirmed diagnosis of HIV-1 infection by two positive assays from two different samples\n* For Group 2, cannot have taken a PI-containing regimen in the 12 months prior to study entry or have ever received a PI for 2 or more weeks\n* For Group 3, must currently be taking the same PI-containing regimen taken continuously for at least 12 months prior to study entry\n\nFor all participants\n\n* Accessible medical and medications history\n* Parent, legal guardian, or participant willing to give informed consent and willing to comply with study requirements\n* Females who have begun menstruating must have negative pregnancy test\n\nExclusion Criteria\n\n* Receipt of certain medications, including growth hormone, megestrol acetate, anabolic agents, anticytokine agents, systemic ketoconazole, systemic glucocorticoids (except if receiving stable physiologic doses), or drugs to treat osteoporosis\n* Type II diabetes mellitus and unable to omit medication prior to specimen collection\n* Pregnancy within the last 12 months, currently pregnant, or breastfeeding\n* History of eating disorder'}, 'identificationModule': {'nctId': 'NCT00069004', 'briefTitle': 'A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth', 'orgStudyIdInfo': {'id': 'P1045'}, 'secondaryIdInfos': [{'id': '10108', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}, {'id': 'PACTG P1045'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB, Dept. of Ped., Div. of Infectious Diseases', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '91803', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'facility': 'Usc La Nichd Crs', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Long Beach Memorial Med. Ctr., Miller Children's Hosp.", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Mother-Child-Adolescent Program CRS', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Pediatric AIDS CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Univ. of Colorado Denver NICHD CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Med. Ctr., ACTU", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard Univ. Washington DC NICHD CRS', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'South Florida CDTC Ft Lauderdale NICHD CRS', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32610-0296', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF - Tampa NICHD CRS', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60608', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Chicago Children's CRS", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane/LSU Maternal/Child CRS', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "HMS - Children's Hosp. Boston, Div. of Infectious Diseases", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08901-1969', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers - New Jersey Medical School CRS', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': "SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS", 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Nyu Ny Nichd Crs', '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': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10037', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Harlem Hosp. Ctr. NY NICHD CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Strong Memorial Hospital Rochester NY NICHD CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11794-8111', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Stony Brook NICHD CRS', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Med. Univ., Dept. of Peds.', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10451', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Lincoln Med. & Mental Health Ctr.', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx-Lebanon Hosp. IMPAACT CRS', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Med. Ctr.', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599-7220', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'DUMC Ped. CRS', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'St. Jude/UTHSC CRS', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hosp. CRS", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Univ. of Puerto Rico Ped. HIV/AIDS Research Program 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': 'Grace Aldrovandi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Alabama at Birmingham'}, {'name': 'Peggy Borum, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Florida'}]}, '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'}], 'responsibleParty': {'type': 'SPONSOR'}}}}