NCT01471821已完成4 期
Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy Instead of a Triple Therapy That Includes Lopinavir/Ritonavir and Lamivudine or Emtricitabine in HIV Patients With Viral Suppression: Controlled Clinical Trial, Open Label, Randomized, of 48 Weeks of Follow-up
Juan A. Arnaiz2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年10月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Proportion of patients with no treatment failure
研究概览
简要总结
This is a prospective, open controlled trial in which HIV-1 with viral suppression patients will be randomized to continue with their current treatment (lopinavir/ritonavir plus emtricitabine or lamivudine plus any nucleoside analogue reverse transcriptase inhibitor) or to simplify to lopinavir/ritonavir plus lamivudine.
Randomization will be stratified according to the values of nadir CD4 and time of viral suppression.
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
- •Patients of either sex (female or male) and 18 years or older.
- •Patients seropositive for HIV-1 using standard diagnostic criteria.
- •There is confirmation of viral load to be lower than 50 cop/ml during the 6 previous months to inclusion. The requirement is to have at least two viral loads lower than 50 cop/mL separated by 6 months and no one >50cop/mL during the 6 months before inclusion.
- •Patients on continuous HAART consisting of LPV/r, emtricitabine (FTC) or 3TC (lamivudine) and an NRTI for at least 2 months before being randomized in this study.
- •Patients who are clinically stable, in the opinion of the investigator, at entry into the study (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization). Patients receiving therapy for an active opportunistic infection are eligible for enrollment if the above criteria are met. Standard prophylaxis of opportunistic infections is permitted.
排除标准
- •Pregnancy, nursing, or planned pregnancy during the study period.
- •Previous failure with regimens including a protease inhibitor (PI) or 3TC/FTC.
- •Known resistance mutations to PIs or 3TC/FTC.
- •Patients with an active opportunistic infection or malignancy. Patients with a stable chronic opportunistic infection may be included in the study.
- •Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
- •Patients diagnosed with visceral Kaposi's sarcoma (KS), patients with lymphoedema secondary to cutaneous KS or cutaneous or palatine KS who have been treated with systemic immunosuppressive therapy must also be excluded.
- •Patients with chronic hepatitis B on treatment with tenofovir + 3TC/FTC
研究组 & 干预措施
simplification
Experimental
Lopinavir/ritonavir (400/100 BID) plus lamivudine (300 QD)
干预措施: antiretroviral treatment (Drug)
Continue with current treatment
Active Comparator
干预措施: antiretroviral treatment (Drug)
结局指标
主要结局
Proportion of patients with no treatment failure
时间窗: 48 weeks
* viral failure, defined as two viral loads above 50 copies/ml at least two weeks apart * death * developing new CDC-C events * withdrawing consent * being lost to follow-up * switching assigned treatment for any cause
次要结局
- Proportion of patients with no viral failure(48 weeks)
- Proportion of patients with no therapeutical failure(48 weeks)
- Time to viral failure(48 weeks)
- Proportion of patients with blips(48 weeks)
- Change from baseline CD4(48 weeks)
- Lipidic profile change from baseline(48 weeks)
- Creatinine clearance change from baseline(48 weeks)
- Proportion of patients with proximal tubular renal disfunction(48 weeks)
- Lipodystrophy changes from baseline(48 weeks)
- Adherence to treatment(48 weeks)
- Mortality and progression to AIDS(48 weeks)
- Adverse events per treatment branch(48 weeks)
- Proportion of patients switching study treatment due to an adverse event(48 weeks)
- Proportion of serious adverse events related to treatment(48 weeks)
研究者
Juan A. Arnaiz
Clinical Trial Manager
Hospital Clinic of Barcelona
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Evaluating the Safety and Immunogenicity of an HIV Vaccine (gp145 C.6980) in Healthy, HIV-Uninfected Adults in the United StatesHIV InfectionsNCT03382418National Institute of Allergy and Infectious Diseases (NIAID)45
已完成
1 期
A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein BG505 SOSIP.GT1.1 Gp140 Vaccine, Adjuvanted in Healthy, HIV-uninfected AdultsHIV InfectionsNCT04224701International AIDS Vaccine Initiative48
已完成
1 期
Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-THIVNCT01543152Sangamo Therapeutics26
已完成
1 期
Evaluating the Safety, Tolerability, and Immunogenicity of a Prime-Boost Regimen of HIV-1 Nef/Tat/Vif, Env pDNA Vaccine Delivered Intramuscularly With Electroporation and HIV-1 rVSV envC Vaccine in Healthy, HIV-Uninfected AdultsHIV InfectionsNCT02654080National Institute of Allergy and Infectious Diseases (NIAID)14
已完成
4 期
Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected PatientsHIV, Combination TherapyNCT01332227Bristol-Myers Squibb132