Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents

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 Isoniazid (INH) therapy for latent tuberculosis (TB) treatment is allowed.
• •Individuals experiencing decompensated cirrhosis
• •Pregnant or lactating females
• •Have any serious or active medical or psychiatric illness which would interfere with 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 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
• •Receiving ongoing therapy with any disallowed medications, including drugs not to be used with EVG, COBI, FTC, TDF or individuals with any known allergies to the excipients of EVG/COBI/FTC/TDF STR tablets