A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 337
- 主要终点
- Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
研究概览
简要总结
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients >=18 years of age;
- •chronic HIV-1 infection;
- •treatment-naive;
- •HIV-1 RNA viral load >=10,000copies/mL;
- •women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days after the last dose of study medication.
排除标准
- •females who are pregnant or breastfeeding;
- •active hepatitis B infection;
- •previous treatment with antiretroviral medication;
- •patients who have received an investigational drug within the last 4 weeks.
研究组 & 干预措施
saquinavir/ritonavir
saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
干预措施: saquinavir [Invirase] (Drug)
saquinavir/ritonavir
saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
干预措施: Emtricitabine/tenofovir disoproxil fumarate (Drug)
saquinavir/ritonavir
saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
干预措施: Ritonavir (Drug)
lopinavir/ritonavir
lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
干预措施: Lopinavir/ritonavir (Drug)
lopinavir/ritonavir
lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
干预措施: Emtricitabine/tenofovir disoproxil fumarate (Drug)
结局指标
主要结局
Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL
时间窗: Week 48
The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults. Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results \<50 copies/mL is reported.
次要结局
- Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters(baseline and all study visits (Up to Week 52))
- Change From Baseline in HIV-1 RNA Viral Load(Baseline to Week 48)
- Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL(Week 48)
- Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count(Baseline to Week 48)
- Number of Participants Assessed for Adverse Events (AEs)(reported up to 28 days after the last dose of study treatment. (Up to 52 weeks))