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P1080 / ARV & Psychiatric Medication Concentrations in HIV Infected & Uninfected Children

A Pilot Study of Psychiatric and Antiretroviral Medication
Concentrations in HIV-1 Infected and Uninfected Children and Adolescents

Study Status

Closed to Follow Up

Locality

United States

DAIDS Number

10768

IND Number

Non-IND

Clinical Trials Link

Summary

P1080 is a pilot PK study that will describe the pharmacokinetics of the selected psychiatric medications currently prescribed in HIV-1 infected and uninfected children and adolescents.  Under version 1.0, the specific psychiatric medications were methylphenidate or amphetamine/dextroamphetamine alone (in HIV-uninfected children) or in combination with an EFV-based or a ritonavir-based ARV regimen (in HIV-infected children).  The target enrollment is 90 evaluable subjects > 6 to < 25 years of age; duration of participation is up to 14 months.

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