The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children (NCT00006064) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children
United States, Puerto Rico100 participantsStarted 2000-06
Plain-language 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.
Who can participate
Age range
1 Month – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 be…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00006064
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)