The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Completed

Conditions studied: HIV Infections, HIV Wasting Syndrome, Lipodystrophy

In brief

The purpose of this study is to see how beginning or changing anti-HIV medications affects the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle distribution) of HIV-infected children. This study also looks at how changes in body composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts, height, and weight in HIV-infected children. This study also compares changes in body composition to levels of cytokines (proteins in the body that affect some immune cells) in HIV-infected children who are beginning or changing anti-HIV therapy. Though studies have been done on adults, little is known about the effects of HIV infection and anti-HIV drugs on body composition in children. One theory is that changes in body composition can predict the failure of anti-HIV treatment. If this is true, body composition measurements can be as useful as CD4+ cell counts in determining drug effectiveness.

Key facts

Study ID

NCT00006064

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

100

Starts

2000-06-01

Expected to finish

2005-02-01

Last updated by the study team

2014-10-29

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children may be eligible for this study if they:
• Are 1 month to 12 years old.
• Are HIV-1 positive.
• Have not begun puberty.
• Are beginning or changing anti-HIV therapy and:
• (1) have never used anti-HIV drugs and are starting any anti-HIV therapy; or (2) have never used protease inhibitors (PIs) and are starting a PI-containing therapy; or (3) have used PIs in the past and are changing anti-HIV treatment and have never used at least 2 of the drugs in the new therapy.
• Have a parent or legal guardian able and willing to provide signed informed consent.

You may not qualify if…

• Children will not be eligible for this study if they:
• Have cancer.
• Use metal artificial body parts or electrical devices that have been inserted into the body (such as a pacemaker).
• Have had an arm or leg removed.
• Have a physical disability that would prevent an accurate measurement of body height or length.
• Have diabetes and need insulin.
• Have or have had a serious illness or fever in the 14 days before entering study (except an upper respiratory infection without a fever).
• Have used steroids (corticosteroids, anabolic steroids, or megestrol acetate), interleukin, interferon, thalidomide, or GH within 180 days before entering study. Glucocorticoids are allowed as long as treatment did not occur during the 14 days before entering study and total treatment in the 180 days before entering study was not more than 15 days.
• Have used anti-HIV medication, if they are beginning any anti-HIV therapy.
• Have used PIs, if they are beginning a PI-containing regimen. (Prior use of PIs is allowed if child is changing anti-HIV treatment and he/she has never used at least 2 of the drugs in the new therapy.)

Where it is running

• Jacobi Med. Ctr. Bronx NICHD CRS — The Bronx, New York, United States
• Texas Children's Hosp. CRS — Houston, Texas, United States
• University of Puerto Rico Pediatric HIV/AIDS Research Program CRS — San Juan, PR, Puerto Rico

Full record on ClinicalTrials.gov

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