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临床试验/EUCTR2008-003364-19-FR
EUCTR2008-003364-19-FR进行中（未招募）1 期

A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate theSafety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination with Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

Bristol-Myers Squibb International Corporation0 个研究点目标入组 120 人开始时间: 2008年11月14日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
120
研究概览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 clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Signed Written Informed Consent
  • •1) Freely given informed consent must be obtained from subjects prior to clinical trial
  • •participation, including informed consent for any screening procedures conducted to
  • •establish subject eligibility for the trial;
  • •Target Population
  • •2) Screening HIV-1 RNA = 5000 c/mL
  • •3) Screening CD4 cell count meeting one of the following criteria:
  • •a) < 350 cells/mm³
  • •b) Screening CD4 = 50 and = 500 cells/mm³ ONLY if at least one of the following
  • •conditions apply:
  • •i) Screening HIV RNA > 100,000 c/mL , or
  • •ii) CD4 decline > 50 - 100 cells/mm³/year, or
  • •iii) age = 55 years
  • •c) Any CD4 cell count if subject has a history of an AIDS defining illness (see
  • •Protocol Appendix 7)
  • •4) Antiretroviral treatment-naive, as defined by:
  • •a) No prior treatment with ATV or RAL or TDF/FTC or 3TC either for treatment or
  • •prophylaxis.
  • •b) No antiretroviral therapy with drugs = 1 week (excluding ATV or RAL or
  • •TDF/FTC or 3TC; see above)
  • •However, in specific settings of antiretroviral treatment including: post exposure
  • •prophylaxis (PEP), pre-exposure prophylaxis (PREP) and/or HAART exposure
  • •for reduction of risk of mother-to-child transmission, the following prior
  • •antiretroviral exposure exceptions will apply, allowing the subject entry into the
  • •i) < 6 weeks of triple antiretroviral therapy (3 drugs of any class, except ATV or
  • •integrase inhibitors or TDF/FTC or 3TC)
  • •ii) < 4 weeks of dual antiretroviral therapy (2 drugs of any class, except ATV or
  • •integrase inhibitors or TDF/FTC or 3TC)
  • •iii) < 1 week of mono-antiretroviral therapy (1 drug of any class, except ATV or
  • •integrase inhibitors or TDF/FTC or 3TC)
  • •5) Medically stable to participate in the study, in the opinion of the investigator, and as determined by medical history, physical examination, and clinical laboratory
  • •evaluations.
  • •Age and Sex
  • •6) Men and women, = age 18 (or minimum age as determined by local regulatory or as legal requirements dictate)
  • •Women of childbearing potential (WOCBP) must be using an adequate method of
  • •contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized. Since acceptable and available methods of contraception vary among
  • •different countries, participating women may choose their preferred contraceptive
  • •method based on physician recommendations.
  • •WOCBP include any female who has experienced menarche and who has not
  • •undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or
  • •bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
  • •Amenorrhea = 12 consecutive months without another cause or
  • •For women with irregular menstrual periods and on hormone replacement therapy
  • •(HRT), a documented serum follicle stimulating hormone (FSH) level = 35 mIU/mL.
  • •Women who are using oral contraceptives, other hormonal contraceptives (vaginal
  • •products, skin patches, or implanted or injectable products), or mechanical products
  • •such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides)
  • •to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential.
  • •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity
  • •25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
  • 另有 2 项未显示

排除标准

  • •Sex and Reproductive Status
  • •1) WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period and for up to 8 weeks after the last dose of
  • •investigational product.
  • •2) WOCBP using a prohibited contraceptive method. Caution is warranted with
  • •co-administration of oral contraceptives (ethinyl estradiol and norethindrone); see
  • •Protocol Appendix 4.
  • •3) Women who are pregnant or breastfeeding
  • •4) Women with a positive pregnancy test on enrollment or prior to investigational
  • •product administration.
  • •Target Disease Exceptions
  • •5) Screening HIV Genotype showing resistance to any component of the study regimen, as described in Protocol Appendix 3;
  • •6) Any antiretroviral therapy within 30 days prior to screening;
  • •7) Presence of a newly diagnosed HIV-related opportunistic infection or any medical
  • •condition requiring acute therapy at the time of enrollment; Suspected primary (acute) HIV infection;
  • •Medical History and Concurrent Diseases
  • •8) Co-infection with human hepatitis B virus (HBV), hepatitis C virus (HCV). HBV
  • •coinfection is defined by HBsAg positive or anti- HBc positive; HCV coinfection is
  • •defined as HCV Ab positive plus detectable HCV RNA.
  • •9) History of or current presence of cardiac disease, defined by presence of arrhythmias, ischemic disease, or a conduction abnormality including left bundle branch block (LBB) or left anterior fascicular block (LAFB), > 1st degree atrioventricular block (AVB), 2nd/3rd degree AVB, or any cardiac abnormality deemed clinically significant by investigator. In addition, the following ECG findings are exclusionary:
  • •a) PR Interval > 260msec (severe first degree AV block)
  • •b) QRS Interval > 120msec
  • •10) Gastro-esophageal reflux disease (GERD), or conditions that would lead the
  • •investigator to believe that there is a significant likelihood that the subject will need
  • •prohibited therapies or medications (eg, Proton Pump Inhibitors) while on study
  • •11) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent
  • •adequate compliance with study therapy or to increase the risk of developing
  • •pancreatitis or chemical hepatitis;
  • •Physical and Laboratory Test Findings
  • •12) Liver enzymes (ALT/AST) > 5 times the upper limit of normal
  • •13) Alkaline phosphatase > 5 times the upper limit of normal
  • •14) Serum creatinine > 1.5 times the upper limit of normal
  • •15) Creatinine clearance < 60 cc/min
  • •16) Bilirubin >1.5 times the upper limit of normal
  • •17) Hemoglobin < 8.0 g/dL
  • •18) Platelets < 50,000 cells/mm3
  • •19) Urine protein = 2+
  • •Prohibited Treatments and/or Therapies
  • •20) Refer to Appendix 4, which details prohibited and cautionary therapies.
  • •Other Exclusion Criteria
  • •21) Prisoners or subjects who are involuntarily incarcerated
  • •22) Subjects who are compulsorily detained for treatment of either a psychiatric or
  • •physical (eg, infectious disease) illness

研究者

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