Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
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Keep this study
Lead
Gilead Sciences
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
12 years to \< 18 years of age at baseline
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
Individuals 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 as a part of local standard of care
Adequate hematologic function
Negative serum pregnancy test for all females
Males and females 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
Males 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
You may not be if
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
Clareo Health | Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
