CTIS2024-511192-15-00进行中（未招募）1 期
Optimizing reversal of HIV latency with combination therapy (pyrimethamine, lenalidomide, panobinostat) - 1.6
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Documented HIV-1 infection by 4th generation ELISA, Western Blot or PCR. •= 18 years old. •World Health Organization (WHO) performance status 0 or 1. •Current plasma HIV RNA <50 copies/ml measured on the last 2 occasions, with measurements being at least 3 months apart. •Uninterrupted prescribed ART for a minimum of two consecutive years. •Considered >95% adherent to ART by treating physician. •Current blood CD4+T-cell count of =200 cells/mm3 •No clinical signs of cellular immunodeficiency or AIDS. •Pre-ART plasma HIV RNA =1000 copies/mL. •Confirmed HIV subtype B. People with a high likelihood of subtype B can participate if they live in a HIV subtype B endemic region with HIV acquired there and in whom no HIV sequencing is available or can be done on stored samples. •People should be considered capable mentally and somatically by their treating physician to understand the informed consent procedure and undergo the study treatment.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: •Previous exposure to any of the studied LRAs in the last year •Acute or chronic co-infection with hepatitis B and/or C by the presence of hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA in blood. •Co-medication with clinically significant interactions with LRA (see chapter 15.h for list) •Comorbidities affected by LRA compounds, such as but not limited to: known Glucose-6-phospate-dehydrogenase (G6PD) deficiency with anaemia, untreated haemolysis of any cause or hereditary thrombophilia not currently treated by anticoagulation. •Prolonged Qtc time >480ms at screening, as measured by electrocardiogram (ECG). •Patients of childbearing potential unless double contraceptive measures are taken. Non-childbearing is defined by one of the following criteria: amenorrhoea for = 1 year, premature ovarian failure, assigned male at birth, or having undergone previous bilateral salpingo-oophorectomy, or hysterectomy •Sexual active patients unwilling to abstain from sex unless willing to use condom protection during and until 1 week after administration of study medication. •Active malignancy during the past year with the exception of basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi’s sarcoma treated with ARTalone or other indolent malignancies. •Registered allergies for any of the investigational medical products •Any lab abnormalities at screening as listed below: •Moderate kidney impairment, defined as eGFR <50 mL/min •Moderate hepatic impairment, defined as bilirubin > 3 x upper limit of normal (ULN) or ALT > 3x ULN •Inadequate blood counts, defined as: Haemoglobin <6.5 mmol/L (males) or <6.0 mmol/L (females), absolute neutrophil count <1000 cells/mm3, thrombocytes <100 x109/L, international standardized ratio >1.6, activated partial thromboplastin time >40 seconds, serum sodium <130 mmol/L, serum potassium <3.0 mmol/L, serum phosphate <0.5 mmol/L, serum calcium <1.9 mmol/L, serum magnesium <0.5 mmol/L.
研究者
相似试验
进行中（未招募）
1 期
A study on HIV eradication by using medicines together.Adults with human immunodeficiency virus type-1 infection on antiretroviral treatment with adequate viral suppression and good cellular immunity.EUCTR2017-002837-48-NLErasmus MC28
尚未招募
1 期
Optimizing Reversal of HIV Latency With Combination TherapyHivNCT06240520Erasmus Medical Center49
已完成
3 期
Optimizing Treatment for Treatment-Experienced, HIV-Infected PeopleHIV InfectionsNCT00537394National Institute of Allergy and Infectious Diseases (NIAID)517
撤回
不适用
Evaluation of Innovative Combinatorial stratégies of Anti-latency and Anti-immune Activation Drugs Targeting HIV ReservoirHIVNCT04741100Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
已完成
不适用
EMPOWER: An evaluation of a combination HIV prevention intervention that includes oral PrEP for adolescent girls and young women in South Africa and TanzaniaPACTR202006754762723Wits Health Consortium500