Non-Therapeutic Protocol

XPD09-189 (P1058A): Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults

Type of Protocol/Clinical Study

Associated Infectious Diseases Studies : Human Immunodeficiency Virus (HIV)

Description

Newer types of anti-HIV medications that interfere with how the HIV gets into and grows in the cell are called entry and integrase inhibitors. When certain HIV medications are taken together, they can change the level of medication in your blood. This study will measure the blood levels of older children, adolescents and young adults. This is called a pharmacokinetic, or PK study.

Results from this study will be compared to the levels of drugs that have been found in other studies that showed that these medications were safe and effective. Any bad reactions that are caused by these anti-HIV medications will be noted.

As part of the PK study, genetic studies will be done using your blood samples, which will measure how your genes (DNA) may affect how your body handles these anti-HIV medication combinations (pharmacogenetics).


Objectives


Eligibility

Principal Investigator

Aditya Gaur, MD

 

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