A clinical research study to examine the pharmacokinetics, safety and efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 infected adolescents.
- Conditions
- Human Immunodeficiency Virus, Type 1 (HIV-1) InfectionMedDRA version: 17.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-000313-40-Outside-EU/EEA
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active
- Sex
- All
- Target Recruitment
- 50
- 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 at screening (Roche COBAS TaqMan v2.0)
- CD4+ cell count > 100 cells/µL
- Weight = 35 kg (77 lbs)
- Screening genotype report provided by Gilead Sciences must show sensitivity to FTC and TDF using the GenoSure RT/PR assay
- Able to swallow oral tablets
- Adequate renal function: Estimated glomerular filtration rate = 90 mL/min/1.73m2 (using Schwartz Formula)
- Clinically normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
- Documented screening for active pulmonary tuberculosis per local standard of care within 6 months of a screening visit
- Hepatic transaminases (AST and ALT) = 5 x upper limit of normal (ULN)
- 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 (absolute neutrophil count = 500/mm3; platelets = 50,000/mm3; hemoglobin = 8.5 g/dL)
- 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. (Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing. It is recommended that an oral contraceptive contain at least 30 µg of ethinyl estradiol if administered with EVG/COBI/FTC/TDF STR.)
- 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- A new AIDS-defining condition (CDC 1993 case definitions, with the exception of CD4+ cell count criteria) 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 (e.g., ascites, encephalopathy, etc.)
- Pregnant or lactating subjects.
- Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol.
- Current alcohol or substance abuse judged by the Investigator to 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 (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Baseline and must not be anticipated to require systemic therapy during the study.
- 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 of the medications listed in the table within the exclusion criteria section of the protocol (Protocol Section 4.3), 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method