Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants

Exclusion Criteria

• •Individuals with CD4+ cell counts at Screening of less than 50, 75, or 200 cells/mm3 dependent on age cohort
• •An AIDS defining condition with onset within 30 days prior to screening
• •Life expectancy of less than 1 year
• •For Individuals with HIV-1 RNA greater than 1,000 copies/mL at screening, prior treatment of any duration with an integrase strand transfer inhibitor.
• •An ongoing serious infection requiring systemic antibiotic therapy at the time of screening.
• •Evidence of active pulmonary or extra-pulmonary tuberculosis disease
• •Anticipated requirement for rifamycin treatment while participating in the study.
• •Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with Individual's treatment, assessment, or compliance with the protocol.
• •Individuals experiencing decompensated cirrhosis
• •A history of or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
• •Pregnant or lactating females.
• •Current alcohol or substance abuse judged by the Investigator to potentially interfere with individual's compliance.
• •Have history of significant drug sensitivity or drug allergy.
• •Known hypersensitivity to the study drug, the metabolites, or formulation excipients.
• •Have previously participated in an investigational trial involving administration of any investigational agent within 30 days prior to the study dosing.
• •Participation in any other clinical trial without prior approval from sponsor is prohibited while participating in this trial.
• •Individuals receiving ongoing therapy with any medication that is not to be taken with EVG or a component of the BR, including drugs not to be used with ritonavir