EUCTR2011-006260-52-BE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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- THERAVECTYS
- 入组人数
- 38
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.Patient infected with clade B HIV-1;
- •2.Confirmation of a Gag clade B genotyping performed at screening;
- •3.Patient must be treated by a triple agents therapy for more than 12 months at baseline: two nucleosidic reverse transcriptase inhibitors plus one boosted protease inhibitor, or two nucleosidic reverse transcriptase inhibitors plus one non nucleosidic reverse transcriptase inhibitor;
- •4.Patient must be treated for more than 60 days at baseline by two (2) nucleosidic reverse transcriptase inhibitors plus a ritonavir boosted protease inhibitor treatment among darunavir+ritonavir or lopinavir+ritonavir;
- •5.Patient’s HIV plasma viral load must have remained = 150,000 copies mL-1 at any monitoring time (apart measurement during primo-infection if recorded);
- •6.Patient with HIV plasma viral load persistently = 50 copies mL-1 during the 12 months prior to screening;
- •7.Patient’s CD4+ T cells count = 300 cells per mm3 at any time since diagnosis;
- •8.Patient’s CD4+ T cells count < 500 cells per mm3 at least once from diagnosis to initiation of antiretroviral treatment
- •9.Patients with CD4+ T cells count = 600 cells per mm3 at baseline;
- •10.Man or woman aged 18-55 years;
- •11.Patient with haematological and biochemical laboratory parameters as follows and within 7 days of baseline:
- •?Haemoglobin > 9.0 g dL-1;
- •?Absolute neutrophil count = 750 mm-3;
- •?Platelets = 100,000 mm-3;
- •?Total serum creatinine = 1.3 x ULN (upper limit of normal);
- •?Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation within 60 days of entry ;
- •?Prothrombin time (PT) < 1.2 x ULN;
- •?Total serum bilirubin < 2.0 x ULN (a higher total bilirubin value may be permitted if the subject was taking atanazir or indinavir and the elevation in total bilirubin is due to increased unconjugated bilirubin);
- •?Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 1.5 x ULN;
- •?Serum lipase less than or equal to 2.0 x ULN;
- •12.Patient should be able and willing to comply with study visits and procedures as per protocol;
- •13.Patient should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures being performed;
- •14.Patient should be affiliated to a social security regimen (for French sites);
- •15.Patients must agree to use in addition to the condom, a second method (one for the patient and one for the partner) of medically acceptable form of contraception during the study and for 3 months after end of study or early termination;
- •16.Women of childbearing potential will enter the study after confirmed menstrual period and a negative pregnancy test In case of pregnancy suspicion, a pregnancy test must be performed immediately.
- •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 38
- •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.Patient treated by HIV entry or fusion inhibitors;
- •3.Patient treated by HIV integrase inhibitors as no safety data, in case of treatment interruption are available for such patients and as these molecules are usually prescribed for patients having medical resistance records;
- •4.Patient displaying any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);
- •5.Patient having undergone virological failure as defined by a viral load = 500 copies mL-1 confirmed by a second measure, since initiation of treatment;
- •6.More than 2 blips with viral load comprised between 50 and 500 copies mL-1 during the 12 months prior inclusion;
- •7.History of an AIDS-defining clinical illness;
- •8.Concomitant AIDS-related opportunistic disease;
- •9.History of allergic disease, anaphylaxis or reactions likely to be triggered or exacerbated by any component of the vaccine such as lactose;
- •10.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);
- •11.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;
- •12.Severe hepatic impairment;
- •13.Serious dyslipidaemia;
- •14.Severe disorders of blood coagulation;
- •15.Known or suspected allergy to egg phospholipids, soy proteins and/or peanut;
- •16.Acute, chronic or history of immunodeficiency or autoimmune disease other than HIV infection;
- •17.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;
- •18.History of malignancy unless there has been surgical excision that is considered to have achieved cure;
- •19.Active malignancy that may require chemotherapy or radiation therapy;
- •20.Seizure disorder or any history of prior seizure;
- •21.Subjects planning to receive a prophylactic or therapeutic vaccination during the study except Influenza immunization;
- •22.Subjects who received any vaccination for the 3 months prior the first injection;
- •23.Subjects having an infective exacerbation as defined as a requirement of inhaled, oral, or intravenous antibiotics at W-2 or later;
- •24.Serious illness requiring systemic treatment and/or hospitalization within 7 days prior to baseline;
- •25.Pregnant or breast-feeding women;
- •26.Any contraindication of intramuscular injection;
- •27.Active drug or alcohol abuse or dependence;
- •28.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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