EUCTR2011-006260-52-FR进行中（未招募）1 期
A multi-center, randomized, double blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination at 5x10E6 TU, 5x10E7 TU or 5x10E8 TU doses to placebo in HIV-1 clade B infected patients under highly active antiretroviral therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- THERAVECTYS
- 入组人数
- 36
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. Patients infected with clade B HIV-1 with a confirmed clade B genotyping performed at screening on the Gag protein;
- •2. Patient taking HAART for more than 24 months and at a stable doses regimen for at least 4 weeks;
- •3. Patients must be taking a ritonavir boosted protease inhibitor treatment among darunavir+ritonavir or lopinavir+ritonavir;
- •4. Patients’ HIV plasma viral load must have remained = 100,000 copies mL-1 at any monitoring time (apart measurement during primo-infection if recorded);
- •5. Patients with HIV plasma viral load persistently = 50 copies mL-1 during the 18 months prior to screening;
- •6. Patients’ CD4+ T cells count = 300 cells per mm3 at any time since diagnosis;
- •7. Patients with CD4+ T cells count = 600 cells per mm3 at baseline;
- •8. Man or woman aged 18-55 years;
- •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 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. HIV-2 infection;
- •2. Any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);
- •3. No virological failure as defined by a viral load = 500 copies mL-1 measured twice, 7-14 days apart, since initiation of treatment;
- •4. A maximum of 2 blips with viral load comprised between 50 and 500 copies mL-1 are authorized during the 18 months prior inclusion;
- •5. History of an AIDS-defining clinical illness;
- •6. Concomitant AIDS-related opportunistic disease;
- •7. History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of the vaccine such as lactose;
- •8. Acute or chronic infectious disease other than AIDS (include but not limited to viral hepatitis such as hepatitis B and hepatitis C, active tuberculosis, active syphilis, HTLV-1, HTLV-2);
- •9. Acute, chronic or history of clinically relevant pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology, angina or cardiac arrhythmias, or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
- •10. In particular, severe hepatic impairment;
- •11. Serious dyslipidemia;
- •12. Severe disorders of blood coagulation;
- •13. Known or suspected allergy to egg phospholipids, soy proteins and/or peanut;
- •14. Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
- •15. Unstable asthma (defined as sudden acute attacks occurring in less than three hours without an obvious trigger, hospitalisation for asthma in the last two years); food or wine induced asthma;
- •16. History of malignancy unless there has been surgical excision that is considered to have achieved cure;
- •17. Active malignancy that may require chemotherapy or radiation therapy;
- •18. Seizure disorder or any history of prior seizure;
- •19. Subjects planning to receive a prophylactic or therapeutic vaccination during the study except Influenza immunization;
- •20. Subjects having an infective exacerbation during the screening process as defined as a requirement of inhaled, oral, or intravenous antibiotics prior to the first study dose;
- •21. Serious illness requiring systemic treatment and/or hospitalization within 7 days prior to study entry;
- •22. Recent (<24 hours) febrile illness on the day of vaccination (temperature > 38°C).
- •23. Pregnant or breast-feeding female;
- •24. Any contraindication of an intramuscular injection;
- •25. Active drug or alcohol abuse or dependence;
- •26. Any condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the study protocol.
研究者
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