Protocol

ELVIS: A Phase 2/3 multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered with a Background Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects

Diseases

Infectious Diseases : HIV

Description

In this study a drug named Elvitegravir (EVG) is used in patients who are currently receiving treatment for HIV-1.

The purpose of this study is to determine the pharmacokinetics of the study drug in your body. Pharmacokinetics (PK) is a type of testing that measures the concentration of the study drug EVG in the blood to look at how the body absorbs (takes drug into the blood), distributes (delivers drug through the blood), and breaks down or processes the drug, and removes it. The purpose of the PK evaluation phase is to determine the best amounts of EVG for children when given in combination with other HIV medications called a Background Regimen (BR) for the treatment of HIV-1 infection.

The safety and how well EVG is handled will be determined based on physical exams, vital signs, laboratory tests, electrocardiograms (ECGs), and questions about any problems experienced during the study.


Objectives


Eligibility criteria, among others, include:

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: 1-888-226-4343 or 901-595-4055
FAX: 901-595-4011

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.