Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
研究概览
简要总结
This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
- •CD4 count ≥100 cells/mm3 at Screening.
- •Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.
排除标准
- •Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
- •Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
- •X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.
研究组 & 干预措施
Arm A
maraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study.
干预措施: maraviroc (Drug)
Arm B
emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD
Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.
干预措施: maraviroc (Drug)
结局指标
主要结局
Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)
时间窗: Week 48
次要结局
- Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96(Baseline, Week 16, Week 24, Week 48, Week 96)
- Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96)
- Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96)
- Time-Averaged Difference (TAD) in log10 Viral Load(Week 16, Week 24, Week 48, Week 96)
- Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96(Baseline, Week 16, Week 24, Week 48, Week 96)
- Maximum Observed Plasma Concentration (Cmax) of Maraviroc(Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose))
- Minimum Observed Plasma Concentration (Cmin) of Maraviroc(Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose))
- Average Observed Plasma Concentration (Cavg) of Maraviroc(Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose))
- Number of Participants With Genotypic Resistance(Week 96 or Time of treatment failure)
- Number of Participants With Phenotypic Resistance(Week 96 or Time of treatment failure)
- HIV-1 RNA Levels at Baseline(Baseline)
- Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14(Baseline , Days 4, 7, 10 and 14)
- Time to Loss of Virological Response (TLOVR)(Baseline through Week 96)
- Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96(Baseline, Week 16, Week 24, Week 48, Week 96)
- Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay(Baseline to Week 96 or Time of treatment Failure)