National, Multicenter, Phase III Prospective Trial About Clinical and Immunological Follow-up After Renal Transplantation in HIV-1 Infected Patients With End Stage Chronic Renal Insufficiency
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 28
- 主要终点
- Incidence of acute clinical renal graft rejection
研究概览
简要总结
The aim of this study is to evaluate the incidence of acute renal graft rejection 6 months after transplantation in HIV-infected patients under three antiretroviral drugs regimen including Raltegravir.
详细描述
Antiretroviral treatment of HIV-1 Infection might interact with immunosuppressive treatments which increase rejection of renal graft incidence.
In addition HIV infection may be modified together with cardiovascular risk. Patients participating to this study will receive after transplantation antiretroviral regimen including Raltegravir.
Raltegravir treatment does not interact with immunosuppressive drugs and thus seems to be the treatment of choice to be associated with immunosuppressive drugs.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registration on the French national renal transplantation waiting list (Biomedicines Agency) for a living or cadaveric donor organ
- •HIV-1-infected patients treated by a three-drug ARV regimen
- •Immuno-virologic criteria at renal transplantation: undetectable viral load (<50 copies/mL) and CD4 >200/mm3 for at least three months on stable ARV
- •Age >18 years and <70 years
- •Effective contraception for women
- •Written informed consent
- •Patient with social security coverage
排除标准
- •Permanent:
- •Hepatic cirrhosis
- •Serious psychiatric illness history
- •EBV or HHV8 lymphoproliferation (lymphoma, systemic Kaposi's sarcoma or multifocal Castleman's disease)
- •History of PML
- •HTLV-1 seropositivity
- •Severe pulmonary or cardiovascular disease with poor short-term vital prognosis
- •Patient with AgHBs+
- •History of cryptosporidiosis
- •History of fungal infection with multi resistant fungi not likely to respond to oral antifungal therapy
- •Impossibility or refusal of Raltegravir switch, decision made by doctor or patient
- •Temporary:
- •Recent malignancy (between 2 and 5 years according to type)
- •HPV-related cervical or anal disease: carcinoma in situ, AIN III, CIN III in remission for less than three years
- •Active infection
- •HCV infection (PCR-positive)
研究组 & 干预措施
Raltegravir
Raltegravir associated to an antiretroviral regimen without ritonavir boosted antiprotease
干预措施: Raltegravir (Drug)
结局指标
主要结局
Incidence of acute clinical renal graft rejection
时间窗: 6 months
Incidence of acute clinical renal graft rejection defined by 20% increase of serum creatinine, associated to histological features (Banff classification) 6 months after renal transplantation
次要结局
- Evaluation of the switch by raltegravir at the time of renal transplantation(1 year)
- Incidence of acute clinical and subclinical renal graft rejection(1 year)
- One year graft survival(1 year)
- Patients' survival(1 year)
- Immunological and virologic status after renal transplantation(1 year)
- Phenotyping of lymphocytic infiltrates in case of acute rejection(1 year)
- Incidence of AIDS defined diseases and severe morbidity diseases after renal transplantation(1 year)
- Viral load control after switch by antiretroviral treatment including raltegravir after renal transplantation(1 year)
- Survival and waiting period of HIV patients registered on French biomedicine agency for renal transplantation(1 year)
- Measurement of Area under plasma concentration (AUC) variability of immunosuppressive drugs after introduction of antiretroviral regimen containing Raltegravir(1 year)