A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate theSafety and Antiretroviral Activity of MK-0518 in Combination With an OptimizedBackground Therapy (OBT), Versus Optimized Background Therapy Alone, in HIVInfected Patients With Documented Resistance to at Least 1 Drug in Each of the 3Classes of Licensed Oral Antiretroviral Therapies - Safety, PK, and Efficacy of MK-0518 plus OBT vs OBT Alone in HIV+

Merck Sharp & Dohme0 个研究点目标入组 366 人开始时间: 2005年12月21日最近更新: 2012年3月20日

试验速览

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•a.Patient is a male or female at least 16 years of age.
•b.Patient has screening plasma HIV RNA (determined by the central laboratory) >1000 copies/mL within 60 days prior to the treatment phase of this study.
•c.Patient is ART experienced and on stable ART for =2 months.
•d.Patient has HIV with documented reduced susceptibility to at least one drug in each of the 3 classes of licensed oral ARTs (NNRTI + NRTI + PI) as per genotypic/phenotypic resistance report from the central laboratory used for this protocol. In cases where the central laboratory resistance sample fails or results are not consistent with prior resistance history, patients may be allowed to enroll based on prior resistance results and ART regimen history, after discussion with the Merck Medical Monitor.
•Are the trial subjects under 18? yes
•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) yes
•F.1.3.1 Number of subjects for this age range

•a.Patient has used another experimental HIV-integrase inhibitor.
•b.Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
•c.Patient has a current (active) diagnosis of acute hepatitis due to any cause or chronic hepatitis other than stable chronic Hepatitis B and/or C.
•d.Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient.
•e.Inability to obtain signed informed consent from a patient age 18 or older, or when a parent/legal representative has provided consent, the inability to obtain assent from a patient 16 or 17 years of age.

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