Pilot Study for the Evaluation of the Safety and the Feasibility of Treatment Simplification to Atazanavir/Ritonavir + Lamivudine in Patients Stably Treated With Two NRTIs + Atazanavir/Ritonavir With Optimal Virologic Response.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis
研究概览
简要总结
Objectives of the study:
- To verify the safety of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to lamivudine + atazanavir with ritonavir.
- To collect relevant information about the safety and the metabolic impact of this strategy in order to eventually design a non-inferiority randomized controlled trial for the evaluation of the safety and the efficacy of this strategy in the future.
详细描述
Combined antiretroviral therapy has greatly improved the natural history of HIV infection/AIDS. Yet, it is associated with important short- and long- term side effects. In particular, nucleoside and nucleotide analogs may cause anemia, pancreatitis, mitochondrial dysfunction, lactic acidosis, lipoatrophy and reduction of renal function or of bone density.
Our study aims to verify the safety and efficacy of a simplification of a dual therapy (Lamivudine plus Atazanavir with Ritonavir), confiding on the potency and high genetic barrier of ritonavir-boosted agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 treated with the same regimen including 2NRTIs + ATV/r from at least 6 months
- •Aged 18 years or older
- •Who gave informed consent to the participation to the study
- •With at least two viral load < 50 copies/mL in two consecutive determinations at least 3 months apart
- •With CD4 cell count > 200 cells/μL and absence of any opportunistic infection or AIDS-related disease by one year at least
排除标准
- •Pregnancy or breast feeding, desire of pregnancy in the short term
- •Previous virological failure to antiretroviral therapy and/or previous exposure to mono- or dual therapies with reverse transcriptase nucleosidic analogues
- •Patients with insufficient atazanavir plasma through concentration (lower than 0.23 μg/mL at 12th hour or 0.15 μg/mL at 24th hour) at screening and/or at baseline
- •Patients with grade 3 or 4 laboratory abnormalities at screening (except for glucose or lipid serum levels and direct or indirect bilirubin)
- •Concomitant treatment with antacids or proton-pump blockers or any other drug with known interactions or contraindications with the study medications
研究组 & 干预措施
Single arm
Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
干预措施: Lamiduvine (Epivir) (Drug)
Single arm
Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
干预措施: Atazanavir (Reyataz) (Drug)
Single arm
Treatment simplification from a "standard" combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy.
干预措施: Ritonavir (Norvir) (Drug)
结局指标
主要结局
Number of Patients With Virological Failure (Two Consecutive Measures of HIV-RNA Higher Than 50 Copies/mL or a Single Measure Higher Than 1000 Copies/mL) Within 48 Weeks at intention-to.Treat Analysis
时间窗: 48 weeks
次要结局
- Evolution of CD4 Cell Count During the 48 Weeks(48 weeks)
- Evolution of Atazanavir Plasma Concentrations During the 48 Weeks(48 weeks)
- Change of Metabolic Parameters at 48 Weeks(48 weeks)
- Time to Virological Failure at Survival Analysis(48 weeks)
- Evolution of Adherence and Quality of Life During the 48 Weeks(48 weeks)
- Change of the Results of Neurocognitive Tests at 48 Weeks(48 weeks)
- Change of Bone Density and of Subcutaneous Fat at 48 Weeks(48 weeks)
- Number of Patients With Viral Load Lower Than 50 Copies/mL at 48 Weeks at the Intention to Treat Analysis(48 weeks)
研究者
Andrea De Luca
Professor
Catholic University of the Sacred Heart