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

Completed

• Conditions: HIV Infections; HIV-Associated Lipodystrophy Syndrome; HIV Lipodystrophy Syndrome; Lipodystrophy; Dyslipidemia; Osteoporosis; Osteopenia

• Registration Number: NCT00069004
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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).

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 Timeline

• Study First Submitted: 2003-09-12
• Study First Submitted QC: 2003-09-15
• Study First Posted: 2003-09-16
• Study Start: 2003-10
• Study Completion: 2005-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-06
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (38)

UAB, Dept. of Ped., Div. of Infectious Diseases; 🇺🇸 Birmingham, Alabama, United States

Usc La Nichd Crs; 🇺🇸 Alhambra, California, United States

Long Beach Memorial Med. Ctr., Miller Children's Hosp.; 🇺🇸 Long Beach, California, United States

UCSD Mother-Child-Adolescent Program CRS; 🇺🇸 San Diego, California, United States

UCSF Pediatric AIDS CRS; 🇺🇸 San Francisco, California, United States

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases; 🇺🇸 Torrance, California, United States

Univ. of Colorado Denver NICHD CRS; 🇺🇸 Aurora, Colorado, United States

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease; 🇺🇸 New Haven, Connecticut, United States

Children's National Med. Ctr., ACTU; 🇺🇸 Washington, District of Columbia, United States

Howard Univ. Washington DC NICHD CRS; 🇺🇸 Washington, District of Columbia, United States

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