Metabolism and Body Shape of Healthy Children and Children With Chronic Infections
Public ClinicalTrials.gov record NCT00001142. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Metabolism and Body Composition of Healthy Children and Children With Chronic Infections
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Some HIV-infected adults develop lipodystrophy that includes significant changes in body shape, with fat losses in the face, arms and legs, and fat gain in the trunk. This lipodystrophy is often accompanied by other disorders of metabolism, such as increased levels of fat and insulin in the blood. The majority of these cases have been seen when patients are taking medications called protease inhibitors. These are anti-retroviral medications designed to treat patients with HIV. It is unclear if lipodystrophy is a result of having HIV or the medication used to treat HIV. It has been suggested, but not proven, that lipodystrophy is a direct side effect of protease inhibitors. In addition, it is unknown if HIV-infected children develop significant lipodystrophy after taking protease inhibitors. This study will investigate the prevalence of metabolic disorders and changes in body fat distribution in children taking protease inhibitor anti-retroviral medications. The results will be compared to three other groups; (1) children suffering from other non-HIV chronic infections, (2) HIV-infected children not taking protease inhibitors, and (3) healthy children. The study will look at HIV-infected children who have already started taking protease inhibitors. It will evaluate these children for disorders in metabolism as well as body fat changes. In addition, the study will follow HIV-infected children who will begin taking protease inhibitors. The study will follow these children for 18 months to detect the development of disorders in metabolism and / or body fat changes.
Study identification
- NCT ID
- NCT00001142
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- NIH
- Enrollment
- 185 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 1999
- Primary completion
- Not listed
- Completion
- Nov 30, 2000
- Last update posted
- Mar 3, 2008
1999 – 2000
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institute of Child Health and Human Development (NICHD) | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001142, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2008 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001142 live on ClinicalTrials.gov.