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 (PROTOCOL NUMBER: GS-US-183-0160, Date of Protocol: 04/25/2013
Although more than 20 different antiretrovirals (ARV) in five classes are available for the treatmentof HIV infection in adults, treatment-experienced pediatric patients who do not have control of their virus continue to have limited treatment options. Children with longstanding HIV infectionare in particular need of new classes of drugs that work to fight against HIV resistant with the existing classes of medications. Currently, HIV-infected children have very limited options forwell-tolerated once daily therapy. No once daily INSTI (Intergrased Strand Transfer Inhibitor-class of drug) is currently approved for use in HIV infected children. Thus, for many children who have experienced and/or failed treatment there is currently a need to find more effective medications to be included in second and later-line regimens. Elvitegravir is an HIV integrase inhibitor that has demonstrated in vitro activity against NNRTI (Non-Nucleoside Reverse Transcriptase Inhibitors), NRTI (Nucleoside/Nucleotide Reverse Transcriptase Inhibitors) or PI (Protease Inhibitors) drug resistant HIV. In clinical studies, elvitegravir has shown significant declines in HIV RNA (amount of virus in blood) in treatment-experienced patients with documented drug resistance. The current study is designed to examine the drug level in the body at different time points by drawing blood samples at specific time points throughout the day (PK-pharmacokinetics), safety and antiviral activity, how the medications works in children, when Elvitegravir added to a BR (Background Regimen) containing a ritonavir-boosted PI in HIV infected, antiretroviral treatment-experienced pediatric subjects. The primary objectives of this study are as follows: To evaluate the steady-state PK and confirm the dose ofritonavir-boosted elvitegravir (EVG/r) in HIV infected,antiretroviral treatment-experienced subjects 4 weeks to<18 years of age To evaluate the safety and tolerability of EVG/r in HIVinfected, antiretroviral treatment-experienced subjects 4 weeksto <18 years of ageThe secondary objective of this study is as follows: To evaluate the antiviral activity of EVG/r in HIV infected,antiretroviral treatment-experienced subjects 4 weeks to<18 years of age who are failing their current HAART regimen.