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NCT00004739 · ClinicalTrials.gov registry record · NA
The Metabolic Effects of Protease Inhibitors in HIV Infected Children
A NA study, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- NA
- Development phase
NCT00004739 is a NA study that has completed, run by National Center for Research Resources (NCRR).
The verdict
NCT00004739, a NA study, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- NA
- Development phase
Study Summary
The use of protease inhibitors is increasing in HIV-infected children because this treatment has resulted in improved body weight, improved immune status and less hospitalizations. However, recent reports suggest that these drugs may also be associated with some negative side-effects, specifically a syndrome of diabetes and fat redistribution. Development of the fat redistribution/diabetes syndrome has recently been reported in HIV-infected children, as well as in adults. Diabetes is associated with complications such as increased heart disease, eye disease and loss of kidney function. Thus development of diabetes is a significant problem which could outweigh the benefits obtained by treating patients with protease inhibitors. One major cause of diabetes is lack of normal response to insulin (insulin resistance). Insulin resistance tends to be worse in family members where one or more parent has diabetes, and is also worse in certain ethnic groups. The first major purpose of our study is measure insulin resistance in HIV-infected children who do not take protease inhibitors, and compare our findings to those from patients who are treated with protease inhibitors. We will also follow patients newly treated with protease inhibitors for two years to evaluate changes in insulin sensitivity. These results will be correlated with each patient's family history of diabetes and with ethnicity, and should help us better predict which children are "at risk" for development of diabetes from protease inhibitor therapy. Children with HIV infection often have problems with gaining enough weight and with poor linear growth (height). One likely reason for this is the way their bodies use and store protein. The second purpose of our study is measure protein turnover and to correlate our findings with growth data. We also plan to study the effects of protease inhibitor therapy on protein turnover. We believe that these studies will provide knowledge to help clinicians formulate recomm
Interventions
- DRUG Antiretroviral therapy
Trial Details
| Field | Value |
|---|---|
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004739
The ClinicalTrials.gov registry entry for NCT00004739 describes a study currently listed as completed, categorized as NA. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Antiretroviral therapy is the first listed.
NCT00004739 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004739 about?
NCT00004739 is a clinical study titled "The Metabolic Effects of Protease Inhibitors in HIV Infected Children". The use of protease inhibitors is increasing in HIV-infected children because this treatment has resulted in improved body weight, improved immune status and less hospitalizations. However, recent reports suggest that these drugs may also be associated with some negative side-effects, specifically a...
What is the current status of trial NCT00004739?
This trial is currently completed. It is a NA study.
What interventions are being tested in trial NCT00004739?
The interventions under investigation include: Antiretroviral therapy (DRUG).
Who is sponsoring clinical trial NCT00004739?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.
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