Completed

Insulin Resistance and Protein Turnover in HIV-Infected Children on Protease Inhibitors

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What is being tested

Antiretroviral therapy

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 7 to 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-infected children and the effects of a type of medication known as protease inhibitors. These drugs have shown to improve body weight and immune status, while reducing hospitalizations. However, they may also lead to some negative side-effects, such as diabetes and fat redistribution. Diabetes can cause serious complications like heart disease, eye disease, and kidney function loss. Therefore, it's crucial to understand the potential risks and benefits of using protease inhibitors in children with HIV. The study also considers the impact of family history of diabetes and ethnicity on the development of diabetes in these children. In this study, researchers will measure insulin resistance in HIV-infected children who are not taking protease inhibitors and compare the results with those who are on this treatment. They will also monitor patients starting protease inhibitor therapy for two years to evaluate changes in insulin sensitivity. Additionally, the study will examine how the bodies of HIV-infected children use and store protein, which often affects their weight gain and growth. The impact of protease inhibitor therapy on protein turnover will also be studied. The findings should help clinicians make informed recommendations for nutritional and medical therapy for HIV-infected children.

NCT00004739
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 7 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

2 inclusion criteria required to participate
Inclusion criteria for HIV infected children- a) The participants may be either antiretroviral treatment naive, or experienced. Those individuals who are experienced will be treated with at least one new drug in addition to the protease inhibitor. The selection of the new antiretroviral regimen will be directed by a review of the patient's previous drug treatment history and/or the genetic or phenotypic characteristics of the patient's virus; b) We will recruit subjects from all CDC categories. Disease severity will subsequently be analyzed as a covariate; c) There will be no height, weight or other anthropometric inclusion criterion (these factors will be analyzed as covariates); d) All subjects will be studied when they have not had an acute superinfection for at least four weeks

Inclusion criteria for controls- Control volunteers will be normal healthy children who are matched to the HIV infected population for age, weight and race. Normal health and non-HIV infected status will be determined by history and by medical record review. Ethical considerations preclude HIV testing in normal children. Separate informed consent and assent forms will be utilized for the control and HIV population

2 exclusion criteria prevent from participating
Exclusion criteria for HIV infected children- Use of Megace@ or another progestational agent, use of anabolic steroids, acute superinfection

Exclusion criteria for controls- Previous medical history of any chronic disease or glucocorticoid use in the last six weeks. Adopted children who have no knowledge of family history

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Texas Medical School, Dept. of Pediatrics

Houston, United StatesOpen University of Texas Medical School, Dept. of Pediatrics in Google Maps

University of Utah

Salt Lake City, United States
Completed2 Study Centers