A Randomized, Open Label Study Assessing Safety, Tolerability, and Efficacy of an Induction/Maintenance Treatment Strategy Including Lopinavir/ritonavir (LPV/r) plus Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine (FTC) versus Efavirenz (EFV) plus TDF and FTC in Antiretroviral-Naïve HIV-1/HCV Co-infected Subjects

Abbott GmbH & Co. KG0 个研究点目标入组 200 人开始时间: 2005年5月27日最近更新: 2013年9月30日

试验速览

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•The main criteria for inclusion are:
•Adult male and female patients who have provided written informed consent.
•Plasma HIV-1 RNA>1000 copies/mL and in the investigator's opinion requires HIV therapy.
•Baseline HIV-1 genotypic resistance testing showing susceptibility to EFV,LPV,TDF and FTC (or 3TC).Subject is naive to antiviral therapy or has had <7 days total of any antiretroviral therapy >30 days prior to study drug administration;subject has chronic hepatitis C Virus (HCV) based on HCV RNA at screening; subject not currently undergoing treatment for HCV; Female subjects is not pregnant or breast feeding. Not taking and not planned to need medications contraindicated with LPV/r, EFV TDF or FTC.
•Are the trial subjects under 18?
•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
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Subjects with a history of allergic reaction to lopinavir or to any of the other drugs or inert materials in the study drug formulations; subjects with a significant history of cardiac, neurologic, psychiatric, oncologic or metabolic disease that the Investigator feels would adversely affect his/her participation; chronic hepatitis infection of any other sort apart from HCV; liver biopsy consistent with chronic cirrhosis or a Child Pugh score of C. If for any reason the subject is considered to be an unsuitable candidate by the Investigator.

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