ISRCTN83717528已完成未知
Research In Viral Eradication of HIV Reservoirs - a two-arm (proof of concept) randomised phase II trial
Imperial College London (UK)0 个研究点目标入组 60 人开始时间: 2014年9月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32085823/ results (added 23/09/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 04/02/2016:
- •In total, 52 eligible individuals will be randomised across 6 UK collaborating centres according to the following criteria:
- •1. Aged 18 to 60 years old
- •2. Confirmed primary HIV-1 infection (PHI) by HIV antibody positive with a documented negative antibody test within the previous 3 months, antigen/antibody test positive or equivocal, or HIV-1 antibody positive with confirmed recent infection by PHE Recent Infection Testing Algorithm (RITA) avidity assay.
- •3. Willing to start immediate cART and be randomised to continue cART alone or cART plus intervention (HIV vaccines plus HDACi)
- •4. Hb 12 g/dL (Males), 11 g/dL (Females)
- •5. Weight = 50 kg
- •6. Written informed consent; agree to long-term follow-up (at least 5 years)
- •7. Willing and able to comply with visit schedule and provide blood sampling
- •Previous inclusion criteria:
- •In total, 52 eligible individuals will be randomised across 6 UK collaborating centres according to the following criteria:
- •1. Aged 18 to 60 years old
- •2. Confirmed primary HIV-1 infection (PHI) by HIV antibody positive with a documented negative antibody test within the previous 3 months, antigen/antibody test positive or equivocal, or HIV-1 antibody positive with confirmed recent infection by PHE Recent Infection Testing Algorithm (RITA) avidity assay.
- •3. Willing to start immediate ART and be randomised to continue ART alone or ART plus intervention (HIV vaccines plus HDACi) at week 24
- •4. Hb 12 g/dL (Males), 11 g/dL (Females)
- •5. Weight = 50 kg
- •6. Written informed consent; agree to long-term follow-up (at least 5 years)
排除标准
- •Current exclusion criteria as of 04/02/2016:
- •1. Women of child bearing potential (WCBP)
- •2. Planning to undertake egg donation to a surrogate in a woman who has intact ovaries and no uterus
- •3. Intention to donate sperm or father a child within 6 months of the intervention
- •4. Co-infection with hepatitis B (SAg +ve or detectable HBV DNA levels in blood) or C (HCV RNA +ve)
- •5. Any current or past history of malignancy including anal intraepitheilal neoplasia (AIN) or cervical intraepithelial neopalasia (CIN)
- •6. Concurrent opportunistic infection or other comorbidity e.g. 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 coinfection
- •11. Prior immunisation with any experimental immunogens
- •12. Current or planned immunosuppressive therapy (inhaled corticosteroids are allowed)
- •13. Any history of thromboembolism
- •14. Any inherited or acquired bleeding diathesis including gastric or duodenal ulcers, varices
- •15. Any bleeding diathesis including gastric or duodenal ulcers, varices
- •16. Concurrent or planned use of any drugs contraindicated with vorinostat i.e. antiarrhythmics; any other drugs that prolong QTc; warfarin, aspirin, sodium valproate
- •17. Prior intolerance of any of the investigational medicinal products in the protocol
- •18. Uncontrolled diabetes mellitus defined as an HBA1C>7%
- •19. Any congenital or acquired prolongation of the QTc interval, with normal defined as 0.40s (=400 ms); bradycardia <55 bpm
- •20. 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
- •21. Allergy to egg
- •22. History of anaphylaxis or severe adverse reaction to vaccines
- •23. Planned receipt of vaccines (including vaccines such as yellow fever; hepatitis B, influenza)within 2 weeks of the first vaccination in the study
- •24. Moderate to severe hepatic impairment as defined by Child-Pugh classification
- •25. ALT >5xULN
- •26. Platelets <150x109/L
- •27. eGFR <90 ml/min
- •28. uPCR >30 mg/mmol
- •29. 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 enrollment into the study
- •30. Active alcohol or substance use that, in the Investigator?s opinion, will prevent adequate adherence with study requirements
- •31. Insufficient venous access that will allow scheduled blood draws as per protocol
- •PARTICIPANT INCLUSION CRITERIA FOR RANDOMISATION
- •Additional criteria assessed at approximately week 22 to proceed to randomisation :
- •1. Participant is willing to continue on combination antiretroviral therapy
- •2. HCV PCR negative
- •3. Plasma HIV RNA <50 copies/mL (or <200 copies/mL for the Taqman Roche assay)
- •4. Laboratory parameters:
- •4.1. Platelet count =150x109/L
- •4.2. eGFR =90 ml/min
- •4.3. Hb =12 g/dL(Males), =11 g/dL(Females)
- •4.4. ALT <5 x ULN
- •4.5 uPCR =30 mg/mmol
- •4.6. In diabetics, HbA1C <7%
- •5. QTc interval normal, with normal defined as 0.40 s (400 ms)
- •6. Physical examination: No evidence of organ dysfunction or any clinically significant deviation from normal in physical examination and/or vital signs that in that in the opinion of the investigator
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