A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs
研究概览
简要总结
The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression.
Maintenance of virological suppression and immunological factors are also assessed.
详细描述
Limitations on achieving complete HIV eradication render it necessary to maintain highly active antiretroviral treatment over long periods, which may lead to the development of antiretroviral-associated toxicities. The current standard-of-care HAART regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors (NRTIs). Many studies have demonstrated that NRTIs particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy. This antiretroviral family inhibits also the mitochondrial gamma-DNA polymerase, which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy, pancreatitis and liver dysfunction.
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
- •Males and non-pregnant females
- •Confirmed laboratory diagnosis of HIV infection
- •Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment for at least 3 months
- •Viral load below 400 copies/ml
- •Patients with a clinical peripheral lipoatrophy isolated or associated with a lipohypertrophy self reported by the patient and confirmed by physical examination
排除标准
- •Current antiretroviral therapy with 3 classes of antiretroviral therapy
- •Previous virologic failure with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
- •Intolerance to nevirapine and efavirenz
- •Acute opportunistic infection
- •Transaminase levels over 5 times above the upper normal limit
- •Hepatitis B virus (HBV) co-infection if the patient is receiving lamivudine therapy
- •Ongoing immunotherapy including interleukin-2 (IL-2) and interferon
- •Pregnancy or planned pregnancy
结局指标
主要结局
Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs
次要结局
- Evolution of the viral load (VL) from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48
- Change in CD4 cell count between day 0 (D0) and week 48
- Change in lipid profile and glucidic metabolism between D0 and week 48
- Evolution of SAT/TAT and VAT/TAT between D0 and week 48