EUCTR2014-000828-24-ES进行中（未招募）1 期
A non-comparative phase II trial evaluating the capacity of the dual combination raltegravir/etravirine to maintain virological success in HIV-1 infected patients of at least 45 years of age with an HIV-RNA plasma viremia below 50 copies/mLunder a current boosted protease inhibitor containing regimen. - ETRA
Inserm-ANRS0 个研究点目标入组 160 人开始时间: 2015年6月1日最近更新:
适应症
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
- 160
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
- •- Documented HIV-1 infection.
- •- Age ? 45 years.
- •- Naïve to integrase inhibitor and etravirine.
- •- At least 6 months of stable antiretroviral therapy (ART) including a boosted protease inhibitor, whatever the number of combined drugs.
- •- HIV-RNA plasma VL ? 50 copies/mL during the last 24 months prior to screening visit (W-4), documented by at least 4 time-points with no more than one blip in HIV-RNA plasma viral load between 51 and 200 copies/mL.
- •- HIV-RNA plasma VL ? 50 copies/mL at screening visit (W-4).
- •- Absence of any documented NNRTI (Non-Nucleosidic Reverse Transcriptase Inhibitor) mutation other than K103N at any time in medical history.
- •- Full sensitivity of ETR in HIV DNA genotypic resistance test.
- •- CD4+ lymphocytes > 200 cells/mm3.
- •- Creatinine < 2.5 x ULN.
- •- CPK (Creatine Phospho Kinase) < 6 ULN.
- •- AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase) < 5 ULN.
- •- Hemoglobin > 10 g/dL.
- •- Platelets > 100 000/mm3.
- •- Negative urinary pregnancy test and use of efficient contraception for women of childbearing potential.
- •- For French participants only: patient affiliated or beneficiary of a national insurance scheme (article L1121-11 of the Public health code) (the Medical aid of State or SOUL is not a national insurance scheme)
- •- Patients with a coverage from a social health.
- •- Signed 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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Previous exposure to raltegravir or etravirine.
- •- Positive hepatitis B HBsAg or Positive HBc Ac and negative HBs Ac.
- •- HIV-2 infection.
- •- Active viral hepatitis C requiring a specific treatment during the 24 months of the trial.
- •- Patient with a history of non-compliance or irregular follow-up.
- •- Initiation of a concomitant anti-hypercholesterolemia (e.g. statins) or anti-diabetic treatment within the last 3 months prior the screening visit (W-4).
- •- Patient using: Clopidogrel (Plavix®), Prasugrel (Effient®), Ticagrelor (Brilinta®), Ticlopidine (Ticlid®), Flurbiprofen (Antadys® - Cebutid®), Rifampin (Rifampicin® - Rifadin® - RofactMC - Rifater®), Rifapentine (Priftin®), St John?s wort, Carbamazepine (Tegretol®), Phenobarbital, Phenytoin (Dilantin®),Avanafil (Stendra?), Triazolam (Halcion®).
- •- Concomitant treatment using interferon, interleukins or any other immune-therapy or chemotherapy.
- •- Concomitant prophylactic or curative treatment for an opportunistic infection.
- •- All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and/or trial treatment tolerance.
- •- Subjects under sauvegarde de justice (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
- •- Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.
- •- Pregnant women or breastfeeding women.
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