A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil furamate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naïve Adolescents

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Research

Infectious Diseases

HIV Studies

Supportive HIV Studies

Protocol

QUAD: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil furamate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naïve Adolescents

Diseases

Infectious Diseases : HIV infections

Description

This study is phase II that involves an experimental combination drug named Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate single tablet for the treatment of HIV-1 infection adolescents who have never been treated before. Elvitegravir (EVG) and Cobicistat (COBI) are the two experimental drugs. The purpose of this study is to find out the concentration of the study drug in the body. Researchers will measure the amount of the study drug in the blood and determine how the body absorbs, distributes, metabolizes (processes), and eliminates (removes) it. They will also look at safety of this combination and how well it works.

Objectives

To learn about the drug called EVG/COBI/FTC/TDF STR, which is short for Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in young people ages 12 to 17 years, who have never been treated for HIV-1.

Eligibility Criteria, among others, include:

Participant has not previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing.
Participant does not have history of significant drug sensitivity or drug allergy.
Participant does not have current alcohol or substance abuse judged by the Investigator to potentially interfere with compliance.
Participant is willing and able to comply with all study requirements.
Participant has documented screening for active pulmonary tuberculosis per local standard of care within 6 months of screening visit.
Participant is able to swallow oral tablets.

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.

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