EUCTR2018-001165-16-DK进行中（未招募）1 期
Combining a TLR9 agonist with broadly neutralizing antibodies for reservoir reduction and immunological control of HIV infection: An investigator-initiated randomized, placebo-controlled, phase IIa trial (TITAN) - TITA
Department of infectious Diseases, Aarhus University Hospital0 个研究点目标入组 48 人开始时间: 2018年9月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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
- •- ?Adults age 18-65 year
- •- On antiretroviral therapy for a minimum of 18 months
- •- CD4+ count >500 at screening
- •- HIV-1 RNA plasma level of < 50 copies/mL by standard assays for at least 15 months (a single viral load measurement > 50 but < 500 copies/mL during this time period is allowable)
- •- Viral reservoir sensitivity to 3BNC117 and 10-1074 (analyzed using the PhenoSense HIV mAb Assay, Monogram Biosciences).
- •- Able to give 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 48
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any significant acute medical illness requiring hospitalization in the past 4 weeks
- •- Any evidence of an active AIDS-defining opportunistic infection
- •- Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy
- •- The following laboratory values at screening, the values can be repeated within the screening period, but test results must be available before baseline (Day 0) and checked for eligibility:
- •o Hepatic transaminases (AST or ALT) =3 x upper limit of normal (ULN)
- •o Serum total bilirubin =3 ULN
- •o Estimated glomerular filtration rate (eGFR) =50 mL/min (based on serum creatinine)
- •o Platelet count =100 x109/L
- •o Absolute neutrophil count =1x109/L
- •- Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen or hepatitis C virus RNA in blood
- •- History of:
- •o Malignancy, excluding non-melanoma skin cancers, or organ transplantation
- •- Receipt of strong immunosuppressive or systemic chemotherapeutic agents within 28 days prior to study entry
- •- Known resistance to >2 classes of ART
- •- Known hypersensitivity to the components of lefitolimod, 3BNC117, 10-1074 or their analogues
- •- Pre-existing autoimmune or antibody-mediated diseases
- •- Women who are pregnant or breastfeeding, or with a positive pregnancy test as determined by a positive urine beta- human chorionic gonadotropin test during screening or women of child bearing potential who are unwilling or unable to use an acceptable method of non-estrogen containing contraception (according to the Danish Medicines Agency guidelines) to avoid pregnancy during the study
- •- Males or females who are unwilling or unable to use barrier contraception during sexual intercourse until plasma HIV-1 RNA is undetectable using standard assays
研究者
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