EUCTR2013-002830-19-DE进行中（未招募）1 期
A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide versus Placebo Added to a Failing Regimen Followed by Treatment with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- •-Age = 18 years of age at Screening
- •-Estimated glomerular filtration rate (Cockcroft Gault equation) = 50 mL/min
- •-HIV-1 RNA = 500 copies/mL but =100,000 copies/mL at screening (Roche COBAS TaqMan v2.0)
- •-Currently taking a failing ARV regimen
- •-Screening and historical genotype report (if available) showing either 1 to 3 thymidine-analogue mutations (TAMs) or K65R as well as M184V, and at least one primary NNRTI and/or one primary PI mutation.
- •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 124
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Screening and historical genotype reports (if available) shows Q151M,T69ins or more than 3 thymidine-analogue mutations (TAMs) in RT, or I50L, I84V, N88S in PR.-Patients with Q151M or T69ins present on screening or historical genotype
- •-History of integrase stand transfer inhibitor (INSTI) use
- •-Evidence of chronic viral Hepatitis B or C infection
研究者
相似试验
进行中（未招募）
1 期
A clinical research study involving an experimental drug named Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide Single Tablet Regimen and Tenofovir Alafenamide single agent. This study evaluates if TAF single agent is effective against HIV-1 infected subjects when added to subject’s current antiretroviral regimen that is no longer effective to treat HIV-1 and if subjects can safely switch to E/C/F/TAF STR plus Atazanavir without increasing the amount of virus in their blood.HIV-1 InfectionMedDRA version: 19.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862EUCTR2013-002830-19-GBGilead Sciences, Inc.55
已完成
2 期
A Phase II/III Study of MR19A13A.JPRN-jRCT2031220417obuyo Oya72
招募中
2 期
TALAMESO : A Three-Cohort Phase II trial to Assess the Efficacy of a Maintenance Treatment with TALAzoparib following First Line Platinum-based Chemotherapy in Pleural or Malignant Peritoneal MESOthelioma Patients2024-514104-14-00Hospices Civils De Lyon40
进行中（未招募）
1 期
ot applicableMedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 100000004864Chronic Lymphocytic LeukemiaEUCTR2015-005758-36-ITTG THERAPEUTICS, INC.450
进行中（未招募）
1 期
A Phase 3 Randomise study to Assess the Efficacy and Safety of Ublituximab in Combination with TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination with Chlorambucil in Patients with Chronic Lymphocytic Leukemia (CLL) (A Chronic lymphocytic leukemia (CLL) is a type of cancer that starts from cells that become certain white blood cells (called lymphocytes) in the bone marrow. The cancer (leukemia) cells start in the bone marrow but then go into the blood)Chronic Lymphocytic LeukemiaEUCTR2015-005758-36-GBTG Therapeutics450