EUCTR2017-002837-48-NL进行中（未招募）1 期
HIV Eradication by combining Agents to reverse Latency in vivo (HEAL-1): a randomized controlled trial. - HEAL-1
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
- Erasmus MC
- 入组人数
- 28
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 patients =18 years.
- •2.WHO performance status 0 or 1.
- •3.Confirmed HIV-1 infection by 4th generation ELISA, Western Blot or PCR.
- •4.Wild type HIV infection or polymorphisms associated with at highest low-level resistance to any class of ART according to Stanford HIV drug resistance database.
- •5.On cART.
- •6.Current plasma HIV-RNA <50 copies/mL for at least 365 days and measured on at least 2 occasions of which at least 1 must be obtained within 365 and 90 days prior to study entry.
- •7.Current CD4 count at study entry of =200 cells/mm3.
- •8.Pre-cART HIV-RNA =10.000 copies/mL.
- •9. Pre-cART HIV-RNA =10.000 copies/mL.
- •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 28
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Previous virological failure, defined as either acquired resistance mutations on cART or HIV-RNA >1000 copies/mL twice during cART.
- •2.Uncontrolled hepatitis B or C co-infection.
- •3.Prior exposure to any HDACi, BAFi or other known LRA.
- •4.Prior exposure to cytotoxic chemotherapy during cART.
- •5.Concurrent exposure to strong interacting medication on glucuronidation.
- •6.Exposure within 90 days prior to study entry to immunomodulators, cytokines, systemic antifungals, dexamethasone, vitamin K antagonists, anti-epileptics, antipsychotica, carbapenems, mefloquine, colestyramine, Any documented opportunistic infection related to HIV in the last 90 days.
- •7.Inadequate blood counts, renal and hepatic function tests
- •a.Haemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females), leucocytes <2.5 x109/L, absolute neutrophil count <1000 cells/mm3, thrombocytes <100 x109/L, international standardized ratio >1.6, activated partial thromboplastin time >40 seconds.
- •b.Estimated glomerular filtration rate <50 mL/min (CKD-EPI),
- •c.ALAT or total bilirubin >2.5x upper limit of normal.
- •d.All laboratory values must be obtained within 42 days prior to the baseline visit.
- •8.Megaloblastic anemia due to folate deficiency.
- •9.Pancreatitis in last 6 months, or chronic pancreatitis.
- •10.Active malignancy during the past year with the exception of basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi Sarcoma treated with cART alone, or other indolent malignancies.
- •11.Females in the reproductive age cannot participate. Males cannot participate if they refuse to abstain from sex or condom use in serodiscordant sexual contact during the study.
- •12.Patients with active substance abuse or registered allergies to the investigational medical products.
- •Last, any other condition (familial, psychological, sociological, geographical) which in the investigator’s opinion poses an unacceptable risk or would hamper compliance with the study protocol and follow up schedule, will prohibit participation.
研究者
相似试验
进行中（未招募）
1 期
Optimizing reversal of HIV latency with combination therapy (pyrimethamine, lenalidomide, panobinostat)HIV-1CTIS2024-511192-15-00Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)49
进行中（未招募）
1 期
SMILE: Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor+darunavir/ritonavir in childrEn (PENTA 17).Paediatric HIV-1 InfectionMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2013-001476-37-BEFondazione PENTA ONLUS300
进行中（未招募）
1 期
SMILE: Strategy for Maintenance of HIV suppression with once daiLy Integrase inhibitor+darunavir/ritonavir in childrEn (PENTA 17).Paediatric HIV-1 InfectionMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862EUCTR2013-001476-37-PTFondazione PENTA ONLUS318
进行中（未招募）
1 期
PENTA 17 - SMILEHIV-1 InfectionMedDRA version: 20.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000020174EUCTR2013-001476-37-GBPENTA Foundation300
进行中（未招募）
1 期
SMILE: Strategy for Maintenance of HIV suppression with elvitegravir+darunavir/ritonavir in children (PENTA 17)EUCTR2013-001476-37-ESFondazione PENTA ONLUS318