NCT00143689已完成4 期
A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
研究概览
简要总结
This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing) regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (Combivir + nevirapine and Combivir + Kaletra).
Participants will be randomly assigned to receive one of the following drug combinations:
- lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
- Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
- Combivir and lopinavir/ritonavir twice a day.
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
- •Be HIV-positive
- •Be at least18 years of age
- •Have viral load above 5 000 copies/ml
- •Be likely to comply with the study protocol
- •Agree not to take, for the duration of the study, any drug that is contraindicated with the study drugs
- •Agree not to take any medication, including over-the-counter medicine, alcohol, or street drugs without the knowledge and permission of the principal investigator
排除标准
- •Have ever received antiretroviral therapy
- •Pregnancy or breastfeeding
- •Have abnormal laboratory tests (see investigator)
- •Have received an investigational drug within 30 days of study drugs administration
- •Be receiving systemic chemotherapy
- •Have an acute illness
研究组 & 干预措施
Lopinavir/ritonavir, Zidovudine, Lamivudine
Experimental
Participants will be randomly assigned to receive one of the following drug combinations:
- lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
- Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
- Combivir and lopinavir/ritonavir twice a day.
干预措施: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine (Drug)
结局指标
主要结局
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
时间窗: 48 weeks
次要结局
- Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks(96 weeks)
- Proportions of patients with viral load below 50 and below 400 copies/mL
- Viral load changes from baseline
- Rates and extent of immune reconstitution (CD4 count increase)
- Rates and severity of dyslipidemia and insuline resistance/diabetes
研究者
研究点 (4)
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