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Home > "A" Clinical Trials Conditions > A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth  A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
For Condition: Lipodystrophy,Osteopenia,HIV-Associated Lipodystrophy Syndrome,HIV Infections,HIV Lipodystrophy Syndrome,Osteoporosis,Dyslipidemia
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: 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).
Details: 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. There 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.
Eligibility:
Study Type: Observational, Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Minimum Age/Maximum Age: 7 Years/25 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria For HIV uninfected participants (Group 1) - HIV-1 negative (perinatally HIV-exposed but uninfected participants are eligible) For HIV infected participants (Groups 2 and 3) - Mother-to-child (vertically) transmitted HIV infection - Confirmed diagnosis of HIV-1 infection by two positive assays from two different samples - 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 - For Group 3, must currently be taking the same PI-containing regimen taken continuously for at least 12 months prior to study entry For all participants - Accessible medical and medications history - Parent, legal guardian, or participant willing to give informed consent and willing to comply with study requirements - Females who have begun menstruating must have negative pregnancy test Exclusion Criteria - 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 - Type II diabetes mellitus and unable to omit medication prior to specimen collection - Pregnancy within the last 12 months, currently pregnant, or breastfeeding - History of eating disorder
Total Enrollment: 450
Location and Contact Information:
Overall Study Official:
GraceAldrovandi, Study Chair, University of Alabama, Birmingham
Children's Hospital, Oakland (Pediatric)*Not yet recruiting*
Oakland, California, 94609-1809
United States
Not yet recruitingTeresa Courville 510-428-3885
Yale University School of Medicine*Recruiting*
New Haven, Connecticut, 06504
United States
RecruitingLeslie Hust 203-688-3498
SUNY Upstate Medical University*Recruiting*
Syracuse, New York, 13210
United States
RecruitingMaureen Famiglieni 315-464-6331
Childrens Hospital of Michigan*Not yet recruiting*
Detroit, Michigan, 48201
United States
Not yet recruitingCharnell Cromer 313-745-7857
Harbor-UCLA Medical Center*Recruiting*
Torrance, California, 90509
United States
RecruitingJudy Hayes 310-222-4173
Children's Hospital of Boston*Recruiting*
Boston, Massachusetts, 02115
United States
RecruitingKirk Bertelsen 617-355-8198
Robert Wood Johnson AIDS Program*Recruiting*
New Brunswick, New Jersey, 08901-1969
United States
RecruitingLisa Cerrachio 732-235-7382
University of Med. & Dentistry of NJ/Univ. Hospital*Recruiting*
Newark, New Jersey, 07101-1709
United States
RecruitingPhilip Andrew 973-972-3118
Harlem Hospital*Not yet recruiting*
New York City, New York, 10037
United States
Not yet recruitingDelia Calo 212-939-4045
UCSF, Moffitt Hospital (Pediatric)*Not yet recruiting*
San Francisco, California, 94143-0105
United States
Not yet recruitingDebbie Trevithick 415-476-6480
University of Puerto Rico, U. Childrens Hospital AIDS*Not yet recruiting*
San Juan, , 00936-5067
Puerto Rico
Not yet recruitingSylvia Davila Nieves 787-759-9595
University of Rochester Medical Center*Recruiting*
Rochester, New York, 14642-0001
United States
RecruitingBarbra Murante 585-275-1549
Los Angeles County Medical Center/USC*Recruiting*
Los Angeles, California, 90033
United States
RecruitingEva Operskalski 323-226-2226
Bronx Lebanon Hospital Center*Not yet recruiting*
Bronx, New York, 10457
United States
Not yet recruitingCaroline Nubel 718-960-1020
St. Jude Childrens Research Hospital, Memphis*Not yet recruiting*
Memphis, Tennessee, 38105-2794
United States
Not yet recruitingLaura Utech 901-495-3490
University of Alabama at Birmingham (Pediatric)*Not yet recruiting*
Birmingham, Alabama, 35233
United States
Not yet recruitingTerry Byars 205-558-2328
UCSD Mother, Child & Adolescent HIV Program*Recruiting*
San Diego, California, 92103
United States
RecruitingLinda Proctor 619-543-8080
St. Christophers Hosp. for Children. Philadelphia*Recruiting*
Philadelphia, Pennsylvania, 19134
United States
RecruitingJanet Chen 215-427-5284
Childrens Hospital (U. Colorado Denver)*Recruiting*
Denver, Colorado, 80218-1088
United States
RecruitingCarol Salbenblatt 303-861-6751
Lincoln Medical & Mental Health Center*Recruiting*
Bronx, New York, 10451
United States
RecruitingEdwin Colocho 718-579-5141
Childrens Hospital of Orange County*Recruiting*
Orange, California, 92868
United States
RecruitingStephanie Wronski 714-289-4064
Additional Information:
Study ID Numbers: PACTG P1045;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069004
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A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
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