The Metabolic Effects of Protease Inhibitors in HIV Infected Children
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ClinicalTrials.gov Identifier: NCT00004739 |
Recruitment Status
:
Completed
First Posted
: March 1, 2000
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Antiretroviral therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Prevention |


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Ages Eligible for Study: | 7 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004739
United States, Texas | |
University of Texas Medical School, Dept. of Pediatrics | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
University of Utah | |
Salt Lake City, Utah, United States, 84132 |
ClinicalTrials.gov Identifier: | NCT00004739 History of Changes |
Other Study ID Numbers: |
NCRR-M01RR02558-0130 M01RR002558 ( U.S. NIH Grant/Contract ) |
First Posted: | March 1, 2000 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | December 2003 |
Keywords provided by National Center for Research Resources (NCRR):
Pediatric HIV infection |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |