Multicenter, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Antiretroviral Activity of Raltegravir in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least One Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies - Dose-Ranging Study in HIV-Infected Patients With Documented Resistance to Antiretroviral Therapies

Merck Sharp & Dohme Limited0 个研究点目标入组 0 人开始时间: 2005年2月24日最近更新: 2020年7月20日

适应症

试验速览

暂无简介。

•a. Patient is HIV positive as determined by a positive ELISA and has screening plasma HIV RNA (determined by the central laboratory) >5,000 copies/mL within 35 days prior to the treatment phase of this study.
•b.Patient has a screening CD4 cell count >50 cells/mm3 (determined by the central laboratory) within 35 days prior to the treatment phase of this study.
•c.Patient is ART experienced and on stable ART for >3 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 (PhenoSense GT) from the central laboratory.
•005-10: Patients who completed the original open-label study (this includes patients who were in the open-label extension from double-blind and patients who entered the open-label post virologic failure treatment arm) through Week 96 will be eligible for continuing into this extension period of the study (the 14 day post therapy visit is not required prior to patients entering the extension). All patients must provide informed consent to participate in the extension.
•Are the trial subjects under 18? no
•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 use of NNRTI (Efavirenz, Nevirapine, Delavirdine) in OBT
•c.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.

发起方

Merck Sharp & Dohme Limited