NCT00824421已完成2 期
A Phase 2B Multicenter, Randomized, Double-Blind, Comparative Trial Of UK-453,061, In Combination With Tenofovir Df And Emtricitabine Versus Efavirenz In Combination With Tenofovir DF And Emtricitabine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48
研究概览
简要总结
This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
- •HIV 1 RNA viral load of greater then 1,000 copies/mL
- •Negative urine pregnancy test.
排除标准
- •Suspected or documented active, untreated HIV-1 related opportunist infection or other condition requiring acute therapy at the time of randomization.
- •Subjects with acute Hepatitis B and/or C within 30 days of randomization.
- •Absolute CD4 count <200 cells/mm3.
研究组 & 干预措施
UK- 453,061 Dose One
Experimental
UK 453,061 Dose One plus Truvada
干预措施: UK-453, 061 (Drug)
UK-453,061 Dose Two
Experimental
UK 453,061 Dose Two plus Truvada
干预措施: UK-453, 061 (Drug)
Efavirenz + Truvada
Active Comparator
Efavirenz + Truvada
干预措施: EFV +TVA (Drug)
结局指标
主要结局
Percentage of Participants With Less Than 50 Copies Per Milliliter (Copies/mL) of Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) at Week 48
时间窗: Week 48
Plasma HIV-1 RNA level was determined by validated Roche Amplicor HIV-1 Monitor standard assay.
次要结局
- Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA at Week 24 and 96(Week 24, 96)
- Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA at Week 24, 48 and 96(Week 24, 48, 96)
- Change From Baseline in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
- Time-Averaged Difference (TAD) in Log 10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96(Baseline up to Week 24, 48, 96)
- Percentage of Participants With Response as Determined Using the Time-to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96(Week 24, 48, 96)
- Change From Baseline in Cluster of Differentiation (CD4+) Absolute Cell Count at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
- Change From Baseline in Cluster of Differentiation (CD4+) Percentage Cell Count at Week 24, 48 and 96(Baseline, Week 24, 48, 96)
- Number of Participants With NRTI and NNRTI Resistance-Associated Mutations (RAMs) at Time of Treatment Failure Through Week 24, 48 and 96(Day 1 (pre-dose) through Week 24, 48, 96)
- Number of Participants With Laboratory Test Abnormalities(Baseline up to Week 96 or early termination)
- Population Pharmacokinetic (PK) of Lersivirine(Week 2, 4, 8, 12, 16, 24, 32, 40, 48)
- Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)(Week 2, 4, 8, 12, 16, 24, 32, 40, 48)
- Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Lersivirine(0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hours (hrs) post-dose on Week 4)
- Maximum Observed Plasma Concentration (Cmax) of Lersivirine(0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Lersivirine(0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 24 hrs post-dose on Week 4)
- Plasma Concentration of Lersivirine at 24 Hour(24 hrs post-dose on Week 4)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
2 期
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee OsteoarthritisOsteoarthritis, KneeNCT04368806Nature Cell Co. Ltd.173
已完成
2 期
Thykamine Safety and Efficacy Study in Mild-to-Moderate Atopic DermatitisAtopic Dermatitis EczemaNCT03540043PurGenesis Technologies Inc.162
招募中
2 期
A Study of Trilaciclib Combined With Chemotherapy in the Treatment of Diffuse Large B-Cell Lymphoma PatientsDLBCLNCT06569485Sun Yat-sen University38
已完成
2 期
stekinumab in adolescents with recent-onset type 1 diabetesNutritional, Metabolic, EndocrineType 1 diabetes mellitusISRCTN14274380Cardiff University88
已完成
2 期
Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive BladderUrinary Bladder, OveractiveNCT00479505Pfizer275