A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00069004
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 450
• Locations: 38
• Duration (Months): 22
• Patients Per Site: 11.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; HIV-Associated Lipodystrophy Syndrome; HIV Lipodystrophy Syndrome; Lipodystrophy; Dyslipidemia; Osteoporosis; Osteopenia

Detailed Description

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.

Study Design

• Study Type: Observational
• Official Title: Prevalence of Morphologic and Metabolic Abnormalities in Vertically HIV-Infected and Uninfected Children and Youth
• Study Start Date: Oct 1, 2003
• Actual Study Completion Date: Aug 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama	United States	35233
2	Usc La Nichd Crs	Alhambra	California	United States	91803
3	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California	United States	90806
4	UCSD Mother-Child-Adolescent Program CRS	San Diego	California	United States	92103
5	UCSF Pediatric AIDS CRS	San Francisco	California	United States	94110
6	Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases	Torrance	California	United States	90509
7	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado	United States	80045
8	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut	United States	06510
9	Children's National Med. Ctr., ACTU	Washington	District of Columbia	United States	20010
10	Howard Univ. Washington DC NICHD CRS	Washington	District of Columbia	United States	20060
11	South Florida CDTC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida	United States	33316
12	Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy	Gainesville	Florida	United States	32610-0296
13	USF - Tampa NICHD CRS	Tampa	Florida	United States	33606
14	Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Augusta	Georgia	United States	30912
15	Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program	Chicago	Illinois	United States	60608
16	Chicago Children's CRS	Chicago	Illinois	United States	60614
17	Tulane/LSU Maternal/Child CRS	New Orleans	Louisiana	United States	70112
18	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland	United States	21287
19	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts	United States	02115
20	UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases	New Brunswick	New Jersey	United States	08901-1969
21	Rutgers - New Jersey Medical School CRS	Newark	New Jersey	United States	07103
22	Lincoln Med. & Mental Health Ctr.	Bronx	New York	United States	10451
23	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York	United States	10457
24	Jacobi Med. Ctr.	Bronx	New York	United States	10461
25	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York	United States	11203
26	Nyu Ny Nichd Crs	New York	New York	United States	10016
27	Metropolitan Hosp. Ctr.	New York	New York	United States	10029
28	Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases	New York	New York	United States	10029
29	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York	United States	10037
30	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York	United States	14642
31	SUNY Stony Brook NICHD CRS	Stony Brook	New York	United States	11794-8111
32	SUNY Upstate Med. Univ., Dept. of Peds.	Syracuse	New York	United States	13210
33	UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases	Chapel Hill	North Carolina	United States	27599-7220
34	DUMC Ped. CRS	Durham	North Carolina	United States	27710
35	St. Jude/UTHSC CRS	Memphis	Tennessee	United States	38105
36	Texas Children's Hosp. CRS	Houston	Texas	United States	77030
37	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan		Puerto Rico	00935
38	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico	00936

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Study Chair: Grace Aldrovandi, MD, University of Alabama at Birmingham
• Study Chair: Peggy Borum, PhD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• Smith KY. Selected metabolic and morphologic complications associated with highly active antiretroviral therapy. J Infect Dis. 2002 May 15;185 Suppl 2:S123-7. Review.
• 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.
• 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. Epub 2001 Dec 7. Review.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00069004
• Other Study ID Numbers: P1045; 10108; PACTG P1045
• First Posted: Sep 16, 2003
• Last Update Posted: Jan 7, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): HIV-Associated Lipodystrophy Syndrome; HIV Lipodystrophy Syndrome; Treatment Experienced; Lipodystrophy; Dyslipidemia; Osteoporosis; Osteopenia
• Additional relevant MeSH terms: HIV-Associated Lipodystrophy Syndrome; Osteoporosis; Bone Diseases, Metabolic; Lipodystrophy; Dyslipidemias; Syndrome

Study Results

No Results Posted as of Jan 7, 2014