EUCTR2014-003382-17-BE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 MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects - MK-1439A versus ATRIPLA in treatment-naïve HIV-1 infected subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 680
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 at least 18 years of age on the day of signing the informed consent
- •2.understand the study procedures and voluntarily agree to participate by giving written informed consent (or have a legal representative provide written informed consent, if considered acceptable by local regulatory agencies and/or ERCs/IRBs) for the trial. The subject or his/her legal representative (if considered acceptable by local regulatory agencies and/or ERCs/IRBs) may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •3.be HIV-1 positive as determined by a positive result on an enzyme-immunoassay, have screening plasma HIV-1 RNA (determined by the central laboratory) =1000 copies/mL within 45 days prior to the treatment phase of this study, and have HIV treatment indicated 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.
- •5.have the following laboratory values at screening within 45 days prior to the treatment phase of this study: a) Alkaline phosphatase =3.0 x upper limit of normal b)AST (SGOT) and ALT (SGPT) =5.0 x upper limit of normal c)Hemoglobin=9.0g/dL (if female) or =10.0g/dL (if male)
- •6.calculated creatinine clearance at the time of screening = 50 mL/min., based on the Cockcroft-Gault equation
- •7.clinically stable with no signs or symptoms of active infection at the time of entry into the study.
- •8.be highly unlikely to become pregnant or to impregnate a partner.
- •In order to be eligible for participation in study extension 1 at the
- •Week 96 visit, the subject must:
- •9. have completed the Week 96 visit.
- •10. be considered, in the opinion of the investigator, to have derived benefit from study participation through Week 96.
- •11. be considered, in the opinion of the investigator, a clinically
- •appropriate candidate for an additional 96 weeks of treatment with MK-1439A following the end of the base study.
- •12. understand the procedures in study extension 1 and provide
- •written informed consent to enter the study extension, thus continuing for approximately 2 years beyond the base study.
- •In order to be eligible to continue receiving study treatment in study extension 2 at the Week 192 visit, the subject must:
- •13. have completed the Week 192 visit.
- •14. be considered, in the opinion of the investigator, to have derived benefit from MK-1439A by Week 192 of the study.
- •15. be considered, in the opinion of the investigator, a clinically appropriate candidate for an additional 2 years (additional 96 weeks) of treatment with MK-1439A.
- •16. understand the procedures in study extension 2 and have provided written informed consent to enter study extension 2, thus continuing until MK-1439A is commercially available once approved in the local country, or for up to approximately 2 years (whichever comes first) beyond study extension 1.
- •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 675
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
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.
- •4.has documented or known resistance to study drugs including MK-1439, efavirenz, emtricitabine, lamivudine, and/or tenofovir, as defined below:
- •a.Resistance to MK-1439 or efavirenz for the purpose of this study includes the following NNRTI mutations: L100I, K101E, K101P, K103N, K103S, V106A, V106I, V106M, V108I, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, Y188C, Y188H, Y188L, G190A, G190S, H221Y, L234I, P225H, F227C, F227L, F227V, M230L, M230I
- •b.Resistance to emtricitabine, lamivudine and tenofovir includes the following mutations: K65R, M41L, T69S (insertion complex), Q151M, M184I, M184V, L210W, T215F, T215Y, K219E, K219Q, D67N, K70R and K70E.
- •5.has participated in a study with an investigational compound/device within 30 days prior to 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 prohibited medications noted in the protocol.
- •8.has significant hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator.
- •9.has a current (active) diagnosis of acute hepatitis due to any cause.
- •10.has evidence of decompensated liver disease manifested by the presence of or a history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver diseases or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte (CPT) score >9.
- •11.is pregnant, breastfeeding, or expecting to conceive.
- •12.is female and is expecting to donate eggs (at any time during the study) or is male and is expecting to donate sperm (at any time during the study).
- •13.is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
研究者
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