KCT0005329尚未招募未知
Randomized, double-blind, placebo-controlled, dose-increased clinical trials of dose groups to assess safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics after repeated oral administration of AVI-CO-004 for 10 days to male HIV-infected subjects
Avixgen0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 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 Study
入排标准
- 年龄范围
- 19(Year) 至 60(Year)（—）
- 性别
- Male
入选标准
- •1. Inclusion Criteria
- •1) Men who are aged 19 years or older and 60 years or younger at the time of screening
- •2) Those with a body weight of 50kg or more and less than 90kg, and a body mass index of 18.0 kg/m2 or more and less than 28.0 kg/m2 at the time of screening
- •Body mass index(BMI) = body weight (kg)/ {height(m)}2
- •3) Patients diagnosed with HIV-1 infection (confirmed HIV-positive) should have HIV-1 RNA Level of 5,000-100,000 copies/mL at the screening visit and CD4+ T-cell count of 250 cells/mL or higher
- •4) Those who are not experienced with antiretroviral drug therapy in relation to HIV-1 infection treatment
- •5) Those who agreed to use appropriate contraception* and not to donate the sperm during the clinical study period and up to 3 months after the end of the study
- •* Acceptable contraceptive methods: Hormone therapy, Intrauterine devices, Double-barrier method (spermicide and condom, diaphragm, vaginal sponge or cervical cap), Sterilization, Absolute abstinence [Female partner of the male subject also needs to maintain contraception]
- •6) Those who voluntarily decided to participate and agreed in writing to comply with the precautions, after listening to the detailed explanation of this clinical study
排除标准
- •1) Patients who are judged by the investigator to have diseases or medical history corresponding to the clinically significant, active cardiovascular system, respiratory system, kidney, endocrine system, hematology, digestive system, central nervous system, mental illness, or malignant tumors, etc.
- •2) Those who have a history of gastrointestinal disease (Crohn's disease, active ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of the investigational product
- •3) Those who have hypersensitivity to the investigational product or additives or a history of clinically significant hypersensitivity
- •4) Those who are judged by the investigator to be ineligible for participation in the study through the medical examination (history of the disease, physical examination, vital signs, electrocardiogram, laboratory test, and etc.) performed at screening
- •5) Those who show the following numerical values in the laboratory test results at the screening visit
- •- Hemoglobin < 13.0 g/dL
- •- Serum AST or ALT> 2 times the upper limit of normal
- •- Serum total bilirubin > 2 times the upper limit of normal
- •- Positive serology (HBsAg, HCV Ab, Syphilis reagin test) test result (However, if the investigator judges that syphilis serum test result is positive or that the syphilis is completely cured before screening, no further treatment is required)
- •- Estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) <60 mL/min/1.73 m2
- •6) Those who showed values corresponding to systolic blood pressure =150 mmHg or =90 mmHg, diastolic blood pressure =100 mmHg or =60 mmHg in the vital signs in sitting position after resting for more than 5 minutes
- •7) Those who have received immunomodulator (e.g., systemic corticosteroids, interleukins, interferons), or those who have taken other drugs with anti-HIV effect (e.g., hydroxyurea or foscarnet) within 30 days before administration of the investigational product
- •8) Those who have received any vaccine within 30 days before administration of the investigational product
- •9) Those who have QTc interval exceeded 450 ms in 12-lead electrocardiogram at the screening visit
- •10) Those who have a history of substance abuse or showed a positive response to a drug that was concerned about misuse or abuse (amphetamine, cocaine, opiate, barbiturate, benzodiazepine) in the result of urine drug screening test
- •11) Those who have received the investigational product of other clinical study within 90 days before administration of the investigational product
- •12) Those who donated whole blood within 60 days before administration of the investigational product, or who donated the blood components within 30 days before administration of the investigational product
- •13) Those who took ethical medicines or herbal medicines within 14 days before administration of the investigational product, or who took over-the-counter medicines or vitamin preparations within 7 days before administration of the investigational product
- •14) Those who were judged to be ineligible for participation in the clinical study by the investigator due to other reasons
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