A phase 3, randomized, double-blind study to evaluate the safety and efficacy of GS-9350-boosted Atazanavir versus Ritonavir-boosted Atazanavir each administered with Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 infected, antiretroviral treatment-naive adults. - GS-US-216-0114

Gilead Sciences0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年5月6日

试验速览

暂无简介。

•* 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

•* 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.)
•* 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.

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