EUCTR2015-003186-28-DK进行中（未招募）1 期
BIOSKILL: Studying Vacc-4x, an HIV therapeutic vaccine, an assessment of immune-mediated anti-viral effects, when administered with adjuvant GM-CSF prior to HIV latent reservoir activation by the HDAC inhibitor, romidepsin - BIOSKI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 192
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
入选标准
- •1. Male or female subjects.
- •2. Age =18 to = 55 years.
- •3. All subjects must have a serologically documented HIV diagnosis.
- •4. Subjects receiving ART according to the national and/or International guidelines and recommendations observed by the trial centers.
- •5. ART maintained without interruption for at least 3 years prior to randomization.
- •6. Plasma HIV RNA maintained <20 copies/mm3. Should the subject have a record of a viral blip, the blip should have been documented by record of a negative HIV RNA test before the observed blip and a re-controlled negative HIV RNA after the observed blip.
- •7. CD4 count =500 cells/mm3 at screening.
- •8. Documented CD4 nadir of =250 cells/mm3.
- •9. Capability and availability to comply with trial constraints and requirements; evaluation by the investigators, acceptance and signature of the ICF.
- •10. If available, preART viral load levels and CD4 levels values must be taken within 6 months of ART initiation.
- •a. Note: Patient are still eligible if these data are not available.
- •11. Subjects who have never received Vacc-4x.
- •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 192
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with contraindications (hypersensitivity included) to Leukine®, see Appendix 1.
- •2. Subjects with contraindications to the practice of i.d. injections.
- •3. Subjects who have received a HIV experimental therapeutic or preventive vaccination or immune-modulatory or interleukin-based treatment within 3 years of randomization.
- •4. Subjects with a history of treatment with chemotherapeutic agents within 2 years of ran-domization.
- •5. Subjects on a Protease Inhibitor-based regimen during three months preceding randomization.
- •6. History of any latency activating agent, notably HDACi use within 24 months preceding randomization.
- •7. Any vaccinations within 4 weeks of randomization, excluding influenza vaccinations.
- •8. Any acute and clinically significant infection within the last 4 weeks of randomization.
- •9. Subjects with a history of AIDS defining condition.
- •10. Clinical abnormalities, as determined by physical examination alone, indicative of chronic active disease states. Subjects with acute or chronic conditions which are either non-stabilized or not in remission as per the investigator's opinion.
- •11. Subjects with a history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncope episodes, or additional risk factors for Torsades de Pointes (e.g. heart failure, congenital long QT syndrome).
- •12. Subjects receiving concomitant medication according to Appendix 5.
- •13. Subjects with a history of current or past:
- •a. HBV infection.
- •b. HBV/HDV infection.
- •c. HCV infection.
- •14. Subjects with recurrent Herpes Zoster.
- •15. Subjects with recurrent herpes infection (HSV-1 or HSV-2 reactivation) that cannot be controlled with valaciclovir.
- •16. Subjects with clinically significant laboratory abnormalities:
- •a. Hemoglobin =12 g/dL
- •b. Platelet count =150 x109/L
- •c. Absolute neutrophil count =2.0x109/L
- •d. Hepatic transaminases (AST or ALT) =1.5 x ULN
- •e. Serum total bilirubin =1.5 x ULN
- •f. Specific or standard (CRP and CBC) =1.5 x ULN
- •g. eGFR =60 mL/min (based on serum creatinine or other appropriate validated markers)
- •h. Serum potassium, magnesium, phosphorus outside =1.5 x ULN/LLN
- •17. Subjects with acute or chronic major psychiatric conditions (i.e. schizophrenia, major depression or bipolar disease) which are either non-stabilized or not in remission as per the investigator's clinical assessment, or are in need of continual psycho-active medications.
- •18. Subjects with a history of multiple sclerosis including subjects in remission.
- •19. Subjects with a history of substance and/or alcohol abuse/dependency within the last 24 months prior to randomization.
- •20. Males who are unwilling to use barrier contraception during the entire course of the present trial.
- •21. ECG at screening that shows QTc >450 msec for males and >470 msec for women when calculated using the Fridericia formula from either lead V3 or V4.
- •22. Subjects who have switched ART regimens more than once due to
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