Pilot 24week Clinical Trial to Assess the Safety, Tolerability and Efficacy of Dual Therapy With Raltegravir/Lamivudine Combination, Replacing Standard Combination Therapy in HIV-infected Pts With Prolonged Virological Suppression.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Proportion of Patients Free of Therapeutic Failure
研究概览
简要总结
A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological 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
- •Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
- •Patients seropositive for HIV-1 using standard diagnostic criteria.
- •Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
- •Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
- •Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
- •Patients who have signed informed consent to participate in the study.
排除标准
- •Pregnancy, lactation, or planned pregnancy during the study period.
- •Previous failure to an integrase inhibitor-containing regimen.
- •Previous failure to a 3TC or FTC-containing regimen.
- •Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
- •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.
- •Chronic hepatitis B.
研究组 & 干预措施
Group 1 Raltegravir / 3TC (MK0518B
Raltegravir / 3TC (MK0518B ) (50 patients)
干预措施: Raltegravir/3TC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: EFV/TDF/FTC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: ATV/r + TDF/FTC or DRV/r + TDF/FTC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: EFV plus ABC/3TC or RPV/TDF/FTC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: ATV/r plus ABC/3TC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: RAL plus ABC/3TC (Drug)
Group 2 standard combination therapy
NNRTI-Based Regimen:
• EFV/TDF/FTC
PI-Based Regimens:
ATV/r + TDF/FTC or DRV/r + TDF/FTC
INSTI-Based Regimens:
DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC
NNRTI-Based Regimens:
EFV plus ABC/3TC or RPV/TDF/FTC
PI-Based Regimen:
ATV/r plus ABC/3TC
PI-Based Regimens:
DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC
INSTI-Based Regimen:
RAL plus ABC/3TC
And other ART regimens
干预措施: Other ART regimens (Drug)
结局指标
主要结局
Proportion of Patients Free of Therapeutic Failure
时间窗: 24 weeks
Proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death
次要结局
- Efficacy in Virological Suppression Assessed With Ultrasensitive HIV-1 RNA Detection (Limit of Detection 1 Copy/mL)(24 weeks)
- Changes in Peripheral Mononuclear Blood Cells HIV-1 Reservoir(24 weeks)
- Changes in Insulin Resistance (HOMA-IR)(24 weeks)
- Changes in Body Fat Composition(24 weeks)
- Changes in Plasma 25-OH Vitamin D Levels(24 weeks)
- Changes in Estimated Glomerular Filtration Rate (CKD-EPI)(24 weeks)
- Changes in CD38(24 weeks)
- Changes in IL-6(24 weeks)
- Changes in Sleep Quality (Pittsburgh Sleep Quality Index)(24 weeks)
- Changes in Adherence in Both Treatment Arms (Morisky-Green Test)(24 weeks)
- Changes in Total Cholesterol(24 weeks)
- Changes in HDL Cholesterol(24 weeks)
- Changes in LDL Cholesterol(24 weeks)
- Changes in Triglycerides(24 weeks)
- Changes in Bone Mineral Density(24 weeks)
- Changes in Urine Beta-2-microglobulin/Creatinine Ratio(24 weeks)
- Changes in HLA-DR(24 weeks)
- Changes in High Sensitivity C-reactive Protein(24 weeks)
- Changes in Mononuclear Activation SD-14(24 weeks)
- Changes in Mononuclear Activation SD-163(24 weeks)
研究者
Juan A. Arnaiz
Head Clinical Trials Unit
Hospital Clinic of Barcelona