Protocol

P1093: Phase I/II, Multi-Center, Open-Label Pharmacokinetic, Safety, Tolerability and Antiviral Activity of GSK1349572, a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children and Adolescents

Diseases

Infectious Diseases : Human Immunodeficiency Virus

Description

This study is being done to study a new antiretroviral HIV medication called GSK1349572. This drug is a type of medicine called an integrase inhibitor. Integrase inhibitors work by blocking integrase, a protein that HIV needs to enter human cells and make more copies of itself. The study will help find the best amount or dose of GSK1349572 for children and teenagers, when it is taken on its own as well as with other antiretroviral medications. This study will also find out the safety of using this medication in children and adolescents and if there are any side effects from the medication. GSK1349572 has been tested before in animals and in adults but not in children. The study drug (GSK1349572) is experimental and is not approved by the FDA and/or local regulatory authorities for use outside of research in humans.


Objectives


Eligibility

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE  (1-866-278-5833).


Contact

Aditya Gaur, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org


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.