EUCTR2012-000198-21-ES进行中（未招募）1 期
A multicenter randomised opened study to assess the efficacy and safety of the withdrawal of nucleos/tide analogues in HIV-1-infected subjects with complete or intermediate resistance to these analogues, multitreated with virological suppression
Fundació Lluita contra la SIDA0 个研究点目标入组 90 人开始时间: 2012年3月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. HIV-1-infected subjects with age ?18 years old.
- •2. Receiving an antiretroviral therapy including NRTIs
- •3. Have a genotype before the start of the current antiretroviral regimen (if there is more than one genotupes availables, they will be added) documenting the existence of intermediate or complete resistance to one or more NRTIs, according to the criteria of the Spanish Network AIDS Research (ISR), this is? 3 score points. The presence of M184I/V indicates complete resistance to lamivudine or emtricitabine. In case of demonstrating complete resistance torwo NRTIs both drugs will be withdrawn simultaneously.
- •4. Receive at least two active drugs (sensitive) by the same algorithm, being one of them a boosted protease inhibitor. Is also considered as one active drug any NRTI that therefore can not be removed and will be maintained in the regime (eg, tenofovir). Raltegravir and enfuvirtide will be considered active if they are first used in the current regime. Maraviroc is considered active if it is documented R5 tropism before the start of the current regime and previously never failed to treatment with CCR5 antagonists.
- •5. The antiretroviral regimen must have been unchanged during the previous 6 moths.
- •6. Having a plasma HIV-1 RNA < 50 copies/mL during at least the previous 6 months, including at least two determinations, as well as in the inclusion moment.
- •7. Fertile women must use a barrier contraceptive method during the whole study.
- •8. Signature of informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 292
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Chronic hepatitis B infection (defined as HBsAg positive), even with normal AST/ALT values.
- •2. Any active neoplasia or AIDS-defining event.
- •3. Pregnant or breastfeeding.
- •4. Patients with a history of poor adherence or poor adherence anticipated by discretion of the investigator.
研究者
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