Human Immunodeficiency Virus (Type 1) Infection MedDRA version: 14.1 Level: LLT Classification code 10020192 Term: HIV-1 System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: •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 = 2,500 copies/mL at screening •No prior use of any approved or experimental anti-HIV drug for any length of time. •Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y •Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant) •Hepatic transaminases (AST and ALT) = 5 x upper limit of normal (ULN) •Total bilirubin = 1.5 mg/dL •Adequate hematologic function (absolute neutrophil count = 750/mm3; platelets = 50,000/mm3; hemoglobin = 8.5 g/dL) •Serum amylase = 5 x ULN (subjects with serum amylase > 5 x ULN will remain eligible if serum lipase is = 5 x ULN) •Adequate renal function: Estimated glomerular filtration rate = 50 mL/min according to the Cockcroft Gault formula: Male: ((140 – age in years) x (wt in kg))/ (72 x (serum creatinine in mg/dL)) = CLcr (mL/min) Female: ((140 – age in years) x (wt in kg))/ (72 x (serum creatinine in mg/dL)) x 0.85 = CLcr (mL/min) •Females of childbearing potential (as defined in Section 7.8.1) must agree to utilize protocol-recommended methods of contraception (as defined in section 7.8.1), or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study period and for 12 weeks 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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in (or may be discontinued from) this study: •A new AIDS defining condition diagnosed within the 30 days prior to screening (refer to Appendix 5) •Females who are breastfeeding •Positive serum pregnancy test (female of childbearing potential) •Proven or suspected acute hepatitis in the 30 days prior to study entry. •Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study. • Have a history of ongoing active liver disease or experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.) •Have an implanted defibrillator or pacemaker •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. (e.g. requiring inpatient treatment or prolonged outpatient intravenous infusion therapy, exception: intramuscular penicillin for treatment of syphilis). •Subjects receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use as indicated in the table below, including drugs not to be used with FTC, EFV, RPV, TDF, and Atripla (refer to the individual agent’s Prescribing Information); or subjects with known allergies to the excipients of the FTC/RPV/TDF single tablet regimen and/or Atripla tablets. Drug Class Agents Disallowed* Analeptics: Modafinil Antiarrhythmics: Bepridil Anticonvulsants: Phenobarbital, carbamazepine, oxcarbazepine, and phenytoin Antibiotics: Rifabutin, rifampin, rifapentine, telithromycin, troleandomycin Antibacterials: Telithromycin Antidiabetics: Pioglitazone, troglitazone Antifungals: Voriconazole Antihistamines: Astemizole, Terfenadine Antimycobacterials: Rifampin, Rifapentine, Rifabutin Calcium Channel Blockers: Bepridil GI Motility Agents: Cisapride Glucocorticoids (systemic): Dexamethasone Ergot Derivatives: Ergotamine, Ergonovine, Dihydroergotamine, Methylergonovine Herbal/Natural Supplements: St. John’s Wort, Echinaccea Progestogens: Megestrol Acetate Proton Pump Inhibitors: Omeprazole, lansoprazole, rabeprazole, pantoprazole, esomeprazole Neuroleptics: Pimozide Sedatives/Hypnotics: Midazolam, Triazolam * 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. •Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids for immunosupression during the study (e.g., corticosteroids, immunoglobulins, and other immune- or cytokine based therapies). •Any other clinica
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is the proportion of subjects with 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;Main Objective: To evaluate the efficacy of a single tablet regimen of emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) compared with a single tablet regimen of efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, [Atripla®]) in HIV-1 infected, antiretroviral treatment-naïve adult subjects as determined by the achievement HIV-1 RNA < 50 copies/mL at 48 weeks; FDA snapshot analysis.;Secondary Objective: -To evaluate the efficacy, safety and tolerability of the two treatment regimens through 96 weeks of treatment, -To assess change from baseline CD4 count in each treatment arm at 48 & 96 weeks, -To assess genotypic and phenotypic resistance at time of virologic failure, -To evaluate the change from baseline in fasting lipid parameters (total cholesterol, LDL and HDL cholesterol, triglycerides) at 48 & 96 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives of this are: • To evaluate the efficacy, safety and tolerability of the two treatment regimens through 96 weeks of treatment, • To assess change from baseline CD4 count in each treatment arm at 48 & 96 weeks, • To assess genotypic and phenotypic resistance at time of virologic failure, • To evaluate the change from baseline in fasting lipid parameters (total cholesterol, LDL and HDL cholesterol, triglycerides) at 48 & 96 weeks. ;Timepoint(s) of evaluation of this end point: Any point of virologic failure, week 48 and week 96 | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Portugal, Puerto Rico, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trials Information
Gilead Sciences International Limited
Outcome results
None listed