EUCTR2011-000437-36-ES进行中（未招募）1 期
A Phase IIb Randomized, Controlled, Partially-Blinded Trial to Investigate Safety,Efficacy and Dose-response of BMS-663068 in Treatment-experienced HIV-1 Subjects,Followed by an Open-label Period on the Recommended Dose
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key inclusion criteria:
- •Plasma HIV-1 RNA ? 1000 copies/ml
- •Men and women
- •At least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher)
- •Antiretroviral treatment-experienced as defined in this protocol
- •Susceptibility to study drugs by genotype/phenotype/PhenoSense® Entry (AI)
- •CD4+ T-cell count > 50 cells/mm3
- •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 250
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria:
- •Chronic HBV/HCV infection
- •Contraindications to any of study drugs
- •History of resistance to any component of the study regimen (TDF, ATV, RAL)
研究者
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This clinical research study will access the effectiveness (how well it works), safety, tolerability (how well the body stands the drug) and blood levels of combined doses of BMS-663068/GSK3684934, Raltegravir and Tenofovir.Human immunodeficiency virus type 1 (HIV-1)-infectionMedDRA version: 19.0 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestationsEUCTR2011-000437-36-DEViiV Healthcare UK Limited254
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