Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of PI-Associated Increased LDL Cholesterol in HIV-Infected Children, Adolescents, and Young Adults

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Research

HIV Studies

Supportive HIV Studies

Non-Therapeutic Protocol

P1063: Phase I/II Safety and Efficacy Investigation of Atorvastatin for Treatment of PI-Associated Increased LDL Cholesterol in HIV-Infected Children, Adolescents, and Young Adults

Type of Protocol/Clinical Study

Associated Infectious Diseases Studies : Human Immunodeficiency Virus (HIV)

Description

High levels of LDL cholesterol can increase the risk of developing cardiovascular disease. Protease inhibitors (a type of medicine that decreases the level of HIV virus in the blood) have been found to increase LDL cholesterol in some people. Sometimes, changes in diet and exercise can lower levels of LDL cholesterol in people’s blood. Lipitor (generic atorvastatin) is a type of medicine used to lower cholesterol in people who have tried exercising and changing their diet, but whose cholesterol levels remain high.

Lipitor is FDA approved in adults, and in uninfected children in doses of 10mg and 20mg. It has not been studied in HIV-infected children who are taking a protease inhibitor which can increase the level of Lipitor in your blood.

Objectives

to study the safety of Lipitor in HIV-infected children and adolescents who are taking protease inhibitors
to find out how well Lipitor lowers LDL cholesterol levels in children and adolescents who are taking a protease inhibitor as part of their anti-HIV treatment
to look at how anti-HIV medications can affect blood levels of Lipitor
to look at how anti-HIV medications can affect the level of HIV in blood when taken with Lipitor
to look at the effect Lipitor can have on other types of cholesterol and fats in blood

Eligibility

Documentation of HIV-1 infection defined as positive results from two samples collected at different time points.
≥ 10 to < 24 years of age
On a stable antiretroviral therapy regimen for at least 6 months
Able to fast overnight for at least 8 hours on certain study visits

Principal Investigator

Aditya Gaur, MD

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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