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Upstate Active Clinical Trials

Study Title:

A Phase 2/3Multicenter, 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 Ritinavir-Boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-Experienced Pediatric Subjects.

What is the purpose of the study? (in Layman's terms, please describe the study)

To confirm the dose and evaluate the safety and tolerability of ritonavir-boosted elvitegravir (EVG/r) in HIV-1 treatment-experienced subjects aged 4 weeks to less than 18 years of age. The dose of EVG will be determined by intensive pharmacokinetic sampling at Day 10. The safety and antiviral activity of EVG will also be evaluated.

Upstate Institutional Review Board (IRB) Number:

498307

Study/Protocol ID:

GS-US-183-0160

Study Phase:

2/3

Patient Age Group:

Children

Principal Investigator:

Leonard B Weiner

ClinicalTrials.Gov ID:

NCT01923311

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Wendy A Holz
Phone: 315-464-7562
Email: [email protected]

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