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NCT00001142 · ClinicalTrials.gov registry record

Metabolism and Body Shape of Healthy Children and Children With Chronic Infections

A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed
Registry status
185
Enrollment target

NCT00001142: Completed study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

NCT00001142 is a clinical trial that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 185 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001142 has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

COMPLETED
Registry status
185 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 185 participants
Start Date 1999-10
Est. Completion 2000-12

What the finished NCT00001142 record still lists

NCT00001142 is an observational study that tracks outcomes without assigning an intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00001142 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001142 about?

NCT00001142 is a clinical study titled "Metabolism and Body Shape of Healthy Children and Children With Chronic Infections". 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. ...

What is the current status of trial NCT00001142?

This trial is currently completed. The enrollment target is 185 participants. The study started on 1999-10. Estimated completion is 2000-12.

Who is sponsoring clinical trial NCT00001142?

This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00001142, the US trial registry maintained by the National Library of Medicine. NCT00001142 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.