A Phase 1, Placebo-Controlled, Randomised Study of the Safety, Pharmacokinetics and Antiviral Activity of BIT225 in Patients with Human ImmunodeficiencyVirus-1 Infection.

Biotron Limited0 个研究点目标入组 24 人开始时间: 2012年6月29日最近更新: 2020年1月13日

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 24

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 65 Years（—）
性别: All

入选标准

•1. Males or females aged 18 to 65 years.
•2. HIV-1 infection, as documented by a rapid HIV test or any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than rapid HIV and ELISA is acceptable as an alternative confirmatory test.
•3. Antiretroviral therapy naive (defined as no previous ART except if used for pre- or post-exposure prophylaxis or women who were administered ART for prevention of mother to child transmission; in all cases, therapy cannot exceed 12 weeks, and there can be no ART in the last 90 days).
•4. Plasma HIV-1 RNA > 5,000 copies/mL within 30 days before Entry (Day 1) by any FDA-approved test for quantifying HIV-1 RNA at any certified laboratory.
•5. CD4+ count > 350 cells/mm3 within 30 days before Entry (Day 1).
•6. For women of reproductive potential, negative serum or urine pregnancy test with a sensitivity of < 25 miU/mL at Screening (baseline) and Day 1.
•Females of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation),
•Subjects who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives. Acceptable documentation of sterilization and menopause is the woman’s self-reported history of surgical sterilization, menopause or male partner’s asoospermia. Follicle stimulating hormone-release factor (FSH) measurement can be used to document menopausal range.
•7. All subjects must agree not to participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). If participating in sexual activity that could lead to pregnancy, the subject must agree to use two reliable methods of contraception while receiving study treatment and for 6 weeks after stopping study treatment.
•Two of the following methods must be used concomitantly :
•Condoms (male or female) with or without a spermicidal agent
•Diaphragm or cervical cap with spermicide
•Intrauterine device (IUD)
•Hormonal-based contraception.
•8. Adequate venous access in the left or right arm to allow collection of a number of blood samples.
•9. Provide written informed consent to participate in the study and be willing to comply with the study procedures.

排除标准

•1. Currently has any active AIDS defining illness ( according to the CDC Surveillance Case Definition for HIV Infection, AIDS-Defining Conditions, updated December 5, 2008.
•2. Patients who are expected to need systemic antiviral therapy at any time during their participation in the study.
•3. Patients who have received an investigational drug for HIV, HIV vaccine, immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, or other investigational therapy within 30 days prior to study entry.
•4. Acute or chronic viral hepatitis as defined by the presence of: 1) anti-HAV IgM Ab (acute hepatitis A), 2) HCV Ab with a detectable HCV RNA by PCR (acute or chronic hepatitis C) or 3) hepatitis B surface antigen or HBV DNA in subjects with isolated HBcAb, defined as negative HBsAg, negative HBsAb and positive HBcAb (acute or chronic hepatitis B).
•5. History or other evidence of renal disease.
•6. Abnormal hematological and biochemical parameters within 30 days of Entry (Day 1):
•a. Absolute neutrophil count <1000/mm3
•b. Haemoglobin <12 g/L in females or <13 g/L in males
•c. Platelet count <75,000/mm3
•d. Estimated creatinine clearance < 60 mL/minute. Value will be calculated using the Cockcroft-Gault formula.
•e. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase >/= 2.5 times upper limit of normal.
•7. Screening ECG QTc value >/= 450 ms.
•8. Consumption / administration of prohibited concomitant medication (prescribed, over-the-counter or complementary). This list is not exhaustive and any medication taken from 30 days prior to first dose through to the end of the participation in the study must be permitted by the Biotron Medical Monitor in consultation with the Investigator.
•9. Active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
•10. Positive results on urine screen for drugs of abuse (excluding THC) at Screening or Day 1.
•11. History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis requiring more than intermittent non-steroidal anti-inflammatory medications for management, etc).
•12. History of documented or presumed coronary artery disease or cardiovascular disease, or clinically significant arrhythmia.
•13. History of a severe seizure disorder or current anticonvulsant use.
•14. Evidence of an active or suspected cancer or a history of malignancy within 2 years.
•15. History of having received any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study.
•16. History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations, with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease.
•17. Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.
•18. Known allergy/sensitivity

研究者

发起方

Biotron Limited

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