Brief Title
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
Official Title
Effect of Antiretroviral Therapy on Body Composition in HIV-Infected Children
Brief Summary
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.
Detailed Description
Despite accumulating data in adults, little information is available regarding the effects of
HIV infection and antiretroviral therapy on body composition in children. Preliminary
information indicates that lean body mass is lost in preference to fat mass in HIV-infected
children, supporting the theory that failure to thrive in HIV infection is often cytokine
mediated. It can be hypothesized that changes in body composition (lean body mass) may
predict changes in weight growth velocity and may give an early clinical indication of
treatment failure. If so, body composition measurement may yield an additional outcome
measure for clinical trials, equivalent in utility to other laboratory measures of treatment
response, e.g., persistent CD4+ cell count changes. Additionally, if body composition changes
are highly correlated with responses in viral load, body composition may prove to be a more
affordable measure of antiretroviral effectiveness in developing countries.
This study is a nonrandomized, observational study. Children are recruited to each of 4 age
strata:
Stratum A: 1 month to 18 months. Stratum B: greater than 18 months to 3 years. Stratum C:
greater than 3 years to 8 years. Stratum D: greater than 8 years to less than 13 years.
Children beginning or changing antiretroviral therapy and fulfilling the study specifications
may be enrolled in the study. Children have 5 outpatient clinic visits, at entry and at 12,
24, 36, and 48 weeks, for anthropometry, body composition by bioelectrical impedance
analysis, cytokine levels, viral load, CD4+ cell count, and markers of lipid and glucose
metabolism.
Study Type
Observational
Condition
HIV Infections
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
June 2000
Completion Date
February 2005
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.)
Gender
All
Ages
1 Month - 12 Years
Accepts Healthy Volunteers
No
Contacts
Caroline Chantry, ,
Location Countries
Puerto Rico
Location Countries
Puerto Rico
Administrative Informations
NCT ID
NCT00006064
Organization ID
P1010
Secondary IDs
10814
Responsible Party
Sponsor
Study Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor
Caroline Chantry, Study Chair,
Verification Date
October 2014