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

Inclusion Criteria:

• 12 years to < 18 years of age at Baseline
• Subjects able to give written assent prior to any screening evaluations
• Parent or guardian able to give written informed consent prior to any screening evaluations and willing to comply with study requirements
• Plasma HIV-1 RNA levels of ≥ 1,000 copies/mL
• CD4+ cell count > 100 cells/µL
• Weight ≥ 35 kg (77 lbs)
• Screening genotype report must show sensitivity to FTC and TDF
• Able to swallow oral tablets
• Adequate renal function
• Clinically normal ECG
• Documented screening for active pulmonary tuberculosis per local standard of care within 6 months of a screening visit
• Hepatic transaminases ≤ 5 x upper limit of normal
• Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
• Subjects with a positive Hepatitis B surface antigen screening test can participate in the study, providing that alternate therapy (other than TDF) for chronic Hepatitis B infection is available to the subjects as a part of local standard of care
• Adequate hematologic function
• Negative serum pregnancy test for all female subjects
• Male and female subjects of childbearing potential must agree to utilize highly effective contraception methods while on study treatment or agree to abstain from heterosexual intercourse throughout the study period and for 30 days following the last dose of study drug
• Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse throughout the study period and for 30 days following discontinuation of investigational medicinal product
• Must be willing and able to comply with all study requirements
• Life expectancy ≥ 1 year

Exclusion Criteria:

• A new AIDS defining condition diagnosed within the 30 days prior to screening
• Prior treatment with any approved or investigational or experimental anti HIV-1 drug for any length of time (other than that given for prevention of mother-to-child transmission
• Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of the screening visit
• Anticipated to require rifamycin treatment for mycobacterial infection while participating in the study. Note: prophylactic INH therapy for latent TB treatment is allowed.
• Subjects experiencing decompensated cirrhosis
• Pregnant or lactating subjects
• Have any serious or active medical or psychiatric illness which would interfere with subject treatment, assessment, or compliance with the protocol. This would include uncontrolled renal, cardiac, hematological, hepatic, pulmonary, endocrine, central nervous, gastrointestinal, vascular, metabolic, immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment within 30 days prior to the study dosing.
• Current alcohol or substance abuse that will potentially interfere with subject compliance
• Have history of significant drug sensitivity or drug allergy
• Known hypersensitivity to the study drugs, the metabolites or formulation excipients
• Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study
• A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
• 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
• Subjects receiving ongoing therapy with any disallowed medications, including drugs not to be used with EVG, COBI, FTC, TDF or subjects with any known allergies to the excipients of EVG/COBI/FTC/TDF STR tablets