Human Immunodeficiency Virus (HIV-1) Infections MedDRA version: 14.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: GS-9350
Product Code: GS-9350
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Cobicistat
Current Sponsor code: GS-9530
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Gilead Sciences Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 (two separate forms of contraception, one of which must be an effective barrier method, 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, or 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
Exclusion criteria
Exclusion criteria: • A new AIDS-defining condition (excluding CD4 cell count and percentage criteria) 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 following medications, including drugs not to be used with GS 9350, FTC, TDF, ATV, and RTV (refer to the list below for drugs which are disallowed for use with GS 9350); or subjects with any known allergies to the excipients of GS 9350 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 St. John’s Wort, Echinaccea HMG-CoA Reductase Inhibitors Simvastatin, Lovastatin, Cerivastatin Neuroleptics Pimozide Sedatives/Hypnotics Midazolam, Triazolam Systemic Corticosteroids with the exception of short-term (<= 1 week) use of prednisone as a steroid burst All agents, including dexamethasone *Administration of any of the above medications must be discontinued at least 21 days prior to the Baseline/Day 1 visit and for the duration of the study. •Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial. •Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a regimen containing GS-9350-boosted atazanavir versus ritonavir-boosted atazanavir, each administered with emtricitabine/tenofovir disoproxil fumarate, in HIV-1 infected, antiretroviral treatment-naïve adult subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.;Secondary Objective: - To evaluate the efficacy, safety and tolerability of the two treatment regimens through 96 weeks of treatment. - To evaluate the durability of the efficacy, safety and tolerability results of the two treatment regimens observed through 192 weeks of treatment;Primary end point(s): Proportion of subjects that achieve HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis. ;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the efficacy, safety and tolerability of the two treatment regimens through 96 weeks of treatment - To evaluate the durability of the efficacy, safety and tolerability results of the two treatment regimens observed through 192 weeks of treatment;Timepoint(s) of evaluation of this end point: - Weeks 96, 144 and 192 - Weeks 48, 96, 144 and 192 | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Contacts
Public ContactClinical Trials Inbox
Gilead Sciences International Ltd
Outcome results
None listed