NL-OMON39337已完成3 期
A phase 3, randomized, double-blind study to evaluate the safety and efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 versus Ritonavir-Boosted Atazanavir plus Emitricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naive adults. - GS-US-236-0103
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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)
- •Age >= 18 years
- •Life expectancy >= 1 year
排除标准
- •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.)
- •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 as listed in the protocol v 15Mar2010 page 44.
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