EUCTR2014-001425-32-GB进行中（未招募）不适用
RIVER - Research In Viral Eradication of HIV Reservoirs, A two-arm (proof of concept) randomised phase II trial - RIVER - Research In Viral Eradication of HIV Reservoirs
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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.Aged =18 to =60 years old
- •2.Able to give informed written consent including consent to long-term follow-up
- •3.Should be enrolled within a maximum of 4 weeks of a diagnosis of primary HIV-1 infection confirmed by one of the following criteria:
- •a.Positive HIV-1 serology within a maximum of 12 weeks of a documented negative HIV-1 serology test result (can include point of care test (POCT))
- •b.A positive p24 antigen result and a negative HIV antibody test
- •c.Negative antibody test with either detectable HIV RNA or proviral DNA
- •d.PHE RITA test algorithm (a) reported as Incident” confirming the HIV-1 antibody avidity is consistent with recent infection (within the preceding 16 weeks)
- •e.Weakly reactive or equivocal 4th generation HIV antibody antigen test
- •f.Equivocal or reactive antibody test with <4 bands on western blot
- •4.Adequate haemoglobin (Hb=12g/dL for males, =11g/dL for females)
- •5.Weight =50kg (b)
- •6.Willing to start immediate cART and be randomised to continue cART alone or cART plus intervention (HIV vaccines plus HDACi) at week 24
- •7.Willing and able to comply with visit schedule and provide blood sampling
- •(a)using current cut-offs for optical density as defined by PHE
- •(b)females aged <20 years of age, and weighing <65kg and <168cm in height will need to have an estimation of blood volume (EBV) prior to enrolment, >3500mL before to participate. This circumstance is unlikely to arise as most women between the ages of 18 to 20 years would be of child-bearing potential (CBP) and excluded on that basis.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Women of child bearing potential (WCBP) (a)
- •2.In women with intact ovaries and no uterus, any planned egg donation anytime in the future to a surrogate
- •3.Intention to donate sperm or father a child within 6 months of the intervention
- •4.Co-infection with hepatitis B (surface antigen positive or detectable HBV DNA levels in blood) or hepatitis C (HCV RNA positive)
- •5.Any current or past history of malignancy
- •6.Concurrent opportunistic infection or other comorbidity or comorbidity likely to occur during the trial e.g.past history of ischaemic or other significant heart disease, malabsorption syndromes, autoimmune disease
- •7.Any contraindication to receipt of BHIVA recommended combination antiretrovirals
- •8.Any contraindication to receipt of the strand-transfer integrase inhibitor (INSTI), raltegravir
- •9.HIV-2 infection
- •10.Known HTLV-1 co-infection
- •11.Prior immunisation with any experimental HIV Immunogens (including any component of the vaccines used in the RIVER protocol; simian or human adenoviral vaccine; other experimental HIV vaccines)
- •12.Current or planned systemic immunosuppressive therapy (inhaled corticosteroids are allowed)
- •13.Any history of proven thromboembolism (pulmonary embolism or deep vein thrombosis)
- •14.Any inherited or acquired bleeding diathesis including gastric or duodenal ulcers, varices
- •15.Concurrent or planned use of any drugs contraindicated with vorinostat i.e. antiarrhythmics; any other drugs that prolong QTc; warfarin, aspirin, sodium valproate
- •16.Prior intolerance of any of either the components of the vaccine or HDACi,
- •17.Uncontrolled diabetes mellitus defined as an HBA1C>7%
- •18.Any congenital or acquired prolongation of the QTc interval, with normal defined as ?0.40s (=400ms); bradycardia <55 bpm
- •19.Participation in any other clinical trial of an experimental agent or any non-interventional study where additional blood draws are required; participation in an observational study is permitted
- •20.Allergy to egg
- •21.History of anaphylaxis or severe adverse reaction to vaccines
- •22.Planned receipt of vaccines (including vaccines such as yellow fever; hepatitis B, influenza) within 2 weeks of the first vaccination at week 24 on study
- •23.Abnormal blood test results at screening including
- •a.Moderate to severe hepatic impairment as defined by Child-Pugh classification
- •b.ALT >5xULN
- •c.Platelets <150x109/L
- •d.eGFR <90 (b)
- •e.uPCR >30 mg/mmol
- •24.Physical and laboratory test findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination and/or vital signs that the investigator believes is a preclusion from enrolment into the study
- •25.Active alcohol or substance use that, in the Investigator’s opinion, will prevent adequate adherence with study requirements
- •26.Insufficient venous access that will allow scheduled blood draws as per protocol
- •(a) defined as any female who has experienced menarche and who has not undergone successful surgical sterilisation (hysterectomy or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhoea = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL); NB bilateral tubal ligation is reversible, a women with only tubal ligation who does not meet any of the other criteria is considered a WCBP.
- •(b)eGFR is calculated by the local labs using CKD-EPI or MDRD, both equations are acceptable. Units ml/min/1.73m2.
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