EUCTR2018-002125-30-ES进行中（未招募）1 期
A Phase IIa, randomized, double-blind, placebo-controlled, study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI with TLR7 agonist vesatolimod (GS-9620), in early treated HIV-1 infection
AELIX Therapeutics0 个研究点目标入组 50 人开始时间: 2018年11月16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
- 50
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.Understands the study information provided and is capable of giving written informed consent.
- •2.Has confirmed HIV-1 infection
- •3.Has received ART, defined as =3 antiretroviral drugs, that was initiated within 6 months of the estimated date of HIV-1 acquisition. The ART regimen is required to have included =3 antiretroviral drugs at the time of treatment initiation and is required to include =3 antiretroviral drugs at screening, but temporary use of a 2drug ART regimen during the time between ART initiation and the screening visit is permitted.
- •4.Has plasma HIV-1 RNA levels <50 copies/mL at the screening visit and has been virologically suppressed, defined as pVL <50 copies/mL, for at least 1 year before the screening; isolated blips allowed (<200 copies/mL, non consecutive, representing <10% of total determinations or ocurrence less than or equal to twice per year).
- •5.Has documented stable CD4 counts =450 cells/mm3 for the 6 months before the screening and at the screening visit.
- •6.Has nadir CD4 count =200 cells/mm3 since human immunodeficiency virus HIV diganosis.
- •7.Is =18 and <61 years of age on the day of the screening visit
- •8.Is willing to comply with all study procedures, including the ATI, collection of blood samples per the protocol and adherence to ART regimen, and is available for the planned duration of the study
- •9.If heterosexually active female and of childbearing potential, must be using highly effective methods of contraception from 14 days before the first vaccination until the end of the study (or 40 days after the last dose of vesatolimod, whichever is later); all female volunteers must be willing to undergo urine pregnancy testing.
- •10. If heterosexually active male, must use condoms or practice sexual abstinence from the screening visit until the end of the study (or 100 days after the last dose of vesatolimod, whichever is later). Female partners of male participants must be using highly effective methods of birth control from the screening visit to the end of the study.
- •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 57
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Is pregnant or lactating at the screening visit or is planning on becoming pregnant over the duration of the study
- •2. If available, has genotypic data (e.g., HIV genotype data) that demonstrate the presence of clinically significant mutations that would prevent the construction of a viable ART regimen post-treatment interruption
- •3. Has reported multiple (consult with medical monitor) periods of suboptimal adherence to ART.
- •4. Has a history of past ART interruptions lasting longer than 2 weeks
- •5. Has participated in another interventional clinical study within 30 days before the screening visit
- •6. Has any acquired immune deficiency syndrome (AIDS) defining disease or progression of HIV related disease within 90 days of the screening visit
- •7. Has a history of any moderate and/or severe autoimmune disease (consult with medical monitor).
- •8. Has a history or clinical manifestations of any physical or psychiatric disorder that could impair the participant’s ability to complete the study
- •9. Is taking HIV protease inhibitors (including low-dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine or nevirapine. Participants on prohibited ART medications will be allowed to switch to an accepted treatment between screening and baseline; participants must be on the new ART regimen at least 14 days prior to the collection of screening laboratory samples. The baseline visit should be completed once all screening laboratory results are available and reviewed.
- •10. Is taking any other concomitant treatments non compatible with vesatolimod before starting treatment in the study. Participants on non compatible medications at screening (e.g., atorvastatin) will be allowed to switch treatments; participants who switch medications must be stopped at least 30 days prior to the first dose of vesatolimod.
- •11. Has received approved vaccines within 2 weeks of study entry or has had a previous immunisation with any experimental immunogens within the previous 2 years.
- •12. Will receive any vaccines within 4 weeks prior to, or 2 weeks after any of the planned CCMM administrations or on a week when vesatolimod is administered
- •13. Has a history of anaphylaxis or a severe adverse reaction to vaccines
- •14. Has received blood products within 6 months of the screening visit
- •15. Has received treatment for cancer or lymphoproliferative disease within 1 year of screening
- •16. Has received any other current or prior therapy within 30 days prior to the screening visit that, in the opinion of the investigators and/or the sponsor, would make the participant unsuitable for the study or influence the results of the study.
- •17. Has current or has had recent use (within last 3 months before the screening visit) of IFN or systemic corticosteroids or other immunosuppressive agents (use of inhaled steroids for pulmonary conditions or topic steroids for localised skin conditions is permitted)
- •18. Have abnormalities of haematology, clinical chemistry and microbiology as below
- •Haemoglobin <11 g/dL (females) or 11.5 g/dL (males)
- •Absolute neutrophil count =1000/mm3 (=1 ×10^9/L)
- •Absolute lymphocyte count =600/mm3 (=0.6 ×10^9/L)
- •Platelets =100,000/mm3 or =550,000/mm3 (=100 x10^3/µL or =550x10^3/µL)
- •Clinical Chemistry
- •Creatinine >1.3 × upper limit of normal (ULN)
- •Aspartate aminotransferase >2.5 × ULN
- •Alanine aminotransferase >2.5 × ULN
- •Microbiology
- •Positive hepatitis B surface antigen
- •Positive for hepatitis C antibody, unless confirmed clearance o
研究者
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