Clinical research study involving an experimental combination medication, i.e. one pill containing two experimental medications EVG and COBI and two approved medications for the treatment of HIV-1 infection, FTC and TDF, referred as EVG/COBI/FTC/TDF. This is a study that neither the patient or the investigator will know whether the patient is receiving EVG/COBI/FTC/TDF or the comparator drug ritonavir-boosted atazanavir with FTC/TDF. This is a randomized (by chance, like a flip of a coin) study.
- Conditions
- Human Immunodeficiency Virus (HIV-1) InfectionsMedDRA version: 15.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2009-016758-42-GB
- Lead Sponsor
- Gilead Sciences Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 715
• The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures
• Plasma HIV-1 RNA levels = 5,000 copies/mL at screening
• No prior use of any approved or investigational antiretroviral drug for any length of time
• Screening genotype report provided by Gilead Sciences must show sensitivity to FTC, TDF and ATV
• Normal ECG (or if abnormal, determined by the Investigator to be not clinically
significant)
• Adequate renal function: Estimated glomerular filtration rate = 70 mL/min according to the Cockcroft-Gault formula
• Hepatic transaminases (AST and ALT) = 5 × upper limit of normal (ULN)
• Total bilirubin = 1.5 mg/dL, or normal direct bilirubin
• Adequate hematologic function (absolute neutrophil count = 1,000/mm3; platelets
= 50,000/mm3; hemoglobin = 8.5 g/dL)
• Serum amylase = 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is = 5 × ULN)
• Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment 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
- Female subjects who have stopped menstruating for = 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
• Male subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse or be non-heterosexually active, practice sexual abstinence from screening throughout the study period and for 30 days following discontinuation of investigational medicinal product.
• Age = 18 years
• Life expectancy = 1 year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 693
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7
• A new AIDS-defining condition diagnosed within the 30 days prior to screening
• Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
• Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
• Females who are breastfeeding
• Positive serum pregnancy test (female of childbearing potential)
• Have an implanted defibrillator or pacemaker
• Have an ECG PR interval = 220 msec
• Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
• 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.
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline.
• Subjects receiving ongoing therapy with any of the medications in the list below,
including drugs not to be used with EVG, GS-9350, FTC, TDF, ATV, RTV (refer to the
individual agents Prescribing Information); or subjects with any known allergies to the excipients of EVG/FTC/TDF/GS-9350 FDC tablets, Truvada® tablets, atazanavir capsules or ritonavir tablets.
Drug Class Agents Disallowed*
Alpha Adrenergic Receptor Antagonists Alfuzosin
Analeptics Modafinil
Antibacterials Telithromycin
Anticonvulsants Phenobarbital, Phenytoin, Carbamazepine,Oxcarbazepine
Antifungals Voriconazole
Antihistamines Astemizole, Terfenadine
Antimycobacterials Rifampin, Rifapentine, Rifabutin
Calcium Channel Blockers Bepridil
Ergot Derivatives Ergotamine, Ergonovine, Dihydroergotamine, Methylergonovine, Ergometrine
GI Motility Agents Cisapride
Herbal/Natural Supplements St. John’s Wort, Echinaccea
HMG-CoA Reductase Inhibitors Simvastatin, Lovastatin, Cerivastatin
Neuroleptics Pimozide
Sedatives/Hypnotics Midazolam, Triazolam
Systemic Corticosteroids with the All agents, including dexamethasone
exception of short term (= 1 week) use
of prednisone as a steroid burst
*Admini
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