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临床试验/EUCTR2013-001939-47-ES
EUCTR2013-001939-47-ES进行中（未招募）1 期

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination With TRUVADAtm, in Treatment-Naïve HIV-1 Infected Subjects - Reformulated raltegravir q.d. (1200 mg) versus raltegravir b.i.d. (400 mg) in ART-naïve pts

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 750 人开始时间: 2014年3月17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
750
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

  • •1. be a male or female at least 18 years of age on the day of signing the informed consent.
  • •2. understand the study procedures, be able to compile with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
  • •Note: A subjects understanding of the procedures for this study includes having the ability to complete the electronic study medication diary.
  • •3. be HIV-1 positive as determined by a positive result by enzyme-immunoassay and have screening plasma HIV-1 RNA (determined by the central laboratory) > or = to 1000 copies/mL within 45 days prior to the treatment phase of this study, and is indicated for treatment based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
  • •4. be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
  • •Note: Naïve is defined as having received no (0 days) ART therapy for the treatment of HIV infection.
  • •5. have the following screening laboratory values:
  • •-Serum creatinine < or = to 2.0 x upper limit of normal
  • •-Alkaline phosphatase < or = to 3.0 x upper limit of normal
  • •-AST (SGOT) and ALT (SGPT) < or = to 5.0 x upper limit of normal
  • •Note: A single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results but the repeat test results must be available within the 45 day screening window.
  • •6. has a calculated creatinine clearance > or = to 30 mL/min at time of screening, based on the following Cockcroft-Gault equations:
  • •Clcr (mL/min) = (140-age) x weight (in kg)
  • •72 x serum creatinine (mg/dL)
  • •Clcr (mL/min) = (140-age) x weight (in kg) x 0.85
  • •72 x serum creatinine (mg/dL)
  • •7. in the opinion of the investigator, be considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study (i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
  • •8. agree to one of the following if of reproductive potential :
  • •True abstinence: Abstinence is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of post-ovulation methods) and withdrawal are not acceptable methods of contraception].
  • •Use of an acceptable method of birth control throughout the study (either by subject or subjects partner). Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy (All forms of hormonal contraception are acceptable).
  • •Note: Subject who is not of reproductive potential1; is not sexually active, whose current partner(s) is/are not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception. However, use of barrier methods of contraception is strongly encouraged to reduce the risk of HIV-1 transmission during sexual contact.
  • •1. A subject who is not of reproductive potential is defined as: one who has reached menopause (no menses for 1 year), undergone hysterectomy, bilateral oophorectomy, tubal ligation, or a s;
  • •1. be a male or female at least 18 years of age on the day of signing the informed consent.
  • •2. understand the study procedures, be able to compile with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
  • •Note: A subjects understanding of the procedures for this study includes having the ability to complete the electronic study medication diary.
  • •3. be HIV-1 positive as determined by a positive result by enzyme-immunoassay and have screening plasma HIV-1 RNA (determined by the central laboratory) > or = to 1000 copies/mL within 45 days prior to the treatment phase of this study, and is indicated for treatment based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
  • •4. be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
  • •Note: Naïve is defined as having received no (0 days) ART therapy for the treatment of HIV infection.
  • •5. have the following screening laboratory values:
  • •-Serum creatinine < or = to 2.0 x upper limit of normal
  • •-Alkaline phosphatase < or = to 3.0 x upper limit of normal
  • •-AST (SGOT) and ALT (SGPT) < or = to 5.0 x upper limit of normal
  • •Note: A single repeat of a laboratory screening test will be allowed for test results that are unexpected based on documented prior laboratory results but the repeat test results must be available within the 45 day screening window.
  • •6. has a calculated creatinine clearance > or = to 30 mL/min at time of screening, based on the following Cockcroft-Gault equations:
  • •Clcr (mL/min) = (140-age) x weight (in kg)
  • •72 x serum creatinine (mg/dL)
  • •Clcr (mL/min) = (140-age) x weight (in kg) x 0.85
  • •72 x serum creatinine (mg/dL)
  • •7. in the opinion of the investigator, be considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study (i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study).
  • •8. agree to one of the following if of reproductive potential :
  • •True abstinence: Abstinence is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of post-ovulation methods) and withdrawal are not acceptable methods of contraception].
  • •Use of an acceptable method of birth control throughout the study (either by subject or subjects partner). Acceptable methods of birth control are: oral contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy (All forms of hormonal contraception are acceptable).
  • •Note: Subject who is not of reproductive potential1; is not sexually active, whose current partner(s) is/are not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception. However, use of barrier methods of contraception is strongly encouraged to reduce the risk of HIV-1 transmission during sexual contact.
  • •1. A subject who is not of reproductive potential is defined as: one who has reached menopause (no menses for 1 year), undergone hysterectomy, bilateral oophorectomy, tubal ligation, or a s;
  • •1. be a male or female at least 18 years of age on the day of signing the informed consent.
  • •2. understand the study procedures, be able to compile with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
  • •Note: A subjects understanding of the procedures for this study includes having the ability to complete the electronic study medication diary.
  • •3. be HIV-1 positive as determined by a positive result by enzyme-immunoassay and have screening plasma HIV-1 RNA (determined by the central laboratory) > or = to 1000 copies/mL within 45 days prior to the treatment phase of this study, and is indicated for treatment based on physician assessment. Local treatment guidelines should be considered in the decision to initiate therapy.
  • •4. be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
  • •Note: Naïve is defined as having received no (0 days) ART therapy for the treatment of HIV infection.
  • 另有 16 项未显示

排除标准

  • •1. has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject?s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
  • •2. is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. The nature and potential clinical context of the subject's illicit drug use, in relation to their exclusion from this trial, will be at the discretion of the investigator.
  • •3. has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
  • •Note: Subjects may be enrolled if treatment with these agents for a viral infection occurred prior to the diagnosis of HIV
  • •4. has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir prior to the treatment phase of the study.
  • •5. has participated in a study with an investigational compound/device within 30 days of signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
  • •6. has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
  • •Note: Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
  • •7. requires or is anticipated to require any of the following prohibited medications while in the study (as also outlined in Section 5.5):
  • •Calcium, magnesium and aluminum containing antacids, such as TUMSTM, MaaloxTM and Milk of MagnesiaTM
  • •Inducers of CYP3A4, including phenobarbital, phenytoin, rifampin, or rifabutin
  • •Noted: Subjects must discontinue phenobarbital, phenytoin, rifampin and rifabutin at least 14 days prior to the treatment phase of the study.
  • •8. has significant hypersensitivity or other contraindication to any of the components of
  • •the study drugs.
  • •9. has a current (active) diagnosis of acute hepatitis due to any cause.
  • •Note: Subjects with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function is defined as a serum albumin <2.8 g/dL or an INR >1.7 in the absence of another explanation for the abnormal laboratory value) at the time of enrollment.
  • •10. is pregnant, breastfeeding, or expecting to conceive at any time during the study.
  • •11. is a female expecting to donate eggs at any time during the study or is a male expecting to donate sperm at any time during the study.
  • •12. is or has an immediate family member (spouse or children) who is investigational site staff or SPONSOR staff directly involved with this trial.
  • •1. has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject?s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
  • •2. is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. The nature and potential clinical context of the subject's illicit drug use, in relation to their exclusion from this trial, will be at the discretion of the investigator.
  • •3. has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
  • •Note: Subjects may be enrolled if treatment with these agents for a viral infection occurred prior to the diagnosis of HIV
  • •4. has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir prior to the treatment phase of the study.
  • •5. has participated in a study with an investigational compound/device within 30 days of signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
  • •6. has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
  • •Note: Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
  • •7. requires or is anticipated to require any of the following prohibited medications while in the study (as also outlined in Section 5.5):
  • •Calcium, magnesium and aluminum containing antacids, such as TUMSTM, MaaloxTM and Milk of MagnesiaTM
  • •Inducers of CYP3A4, including phenobarbital, phenytoin, rifampin, or rifabutin
  • •Noted: Subjects must discontinue phenobarbital, phenytoin, rifampin and rifabutin at least 14 days prior to the treatment phase of the study.
  • •8. has significant hypersensitivity or other contraindication to any of the components of
  • •the study drugs.
  • •9. has a current (active) diagnosis of acute hepatitis due to any cause.
  • •Note: Subjects with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function is defined as a serum albumin <2.8 g/dL or an INR >1.7 in the absence of another explanation for the abnormal laboratory value) at the time of enrollment.
  • •10. is pregnant, breastfeeding, or expecting to conceive at any time during the study.
  • •11. is a female expecting to donate eggs at any time during the study or is a male expecting to donate sperm at any time during the study.
  • •12. is or has an immediate family member (spouse or children) who is investigational site staff or SPONSOR staff directly involved with this trial.
  • •1. has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject?s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
  • •2. is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence. The nature and potential clinical context of the subject's illicit drug use, in relation to their exclusion from this trial, will be at the discretion of the investigator.
  • •3. has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine.
  • •Note: Subjects may be enrolled if treatment with these agents for a viral infection occurred prior to the diagnosis of HIV
  • •4. has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir prior to the treatment phase of the study.
  • •5. has participated in a study with an investigational compound/device within 30 days of signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
  • •6. has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
  • •Note: Short courses of corticosteroids (e.g., as for asthma exacerbation) will be allowed.
  • •7. requires or is anticipated to require any of the following prohibited medications while in the study (as also outlined in Section 5.5):
  • •Calcium, magnesium and aluminum containing antacids, such as TUMSTM, MaaloxTM and Milk of MagnesiaTM
  • •Inducers of CYP3A4, including phenobarbital, phenytoin, rifampin, or rifabutin
  • •Noted: Subjects must discontinue phenobarbital, phenytoin, rifampin and rifabutin at least 14 days prior to the treatment phase of the study.
  • 另有 7 项未显示

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