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

Official Title: 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

Dolutegravir (DTG) (also known as GSK1349572) is a new drug that may slow HIV replication. It works by blocking a protein named integrase, which HIV needs in order to make copies of itself in the human body. This drug has been tested for safety and effectiveness in adults but not in children. This study will test the safety of and immune response to DTG in HIV-1 infected infants, children, and adolescents.

ClinicalTrials.gov ID: NCT01302847

Principal Investigator: Chadwick, Ellen G., MD

Study Type: Interventional

Currently Recruiting Patients: Yes

Contact Information:

Margaret Ann Sanders

Research and Education Coordinator

312-227-8275