EUCTR2015-003616-20-GB进行中（未招募）1 期
A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects with Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations. - MK1439A in treatment naïve HIV1 infected subjects with NNRTI transmitt
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
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.Have a screening CD4 cell count =100 cells/mm3 (completed by the central laboratory) within 45 days prior to the treatment phase of this study.
- •5.Be naïve to antiretroviral therapy (ART) including investigational antiretroviral agents.
- •6.Prior to screening, have documentation of genotype performed confirming the presence of one and only one of the following NNRTI mutations: K103N, Y181C, or G190A. An additional sample must be obtained and analyzed by the central laboratory as a part of the screening process to establish a baseline resistance profile. The results of the central laboratory test results must be available prior to subject enrollment. If, upon receipt of the central laboratory results, a discordance between the local sample drawn prior to screening and central laboratory results is identified, such that exclusion criterion #4 is met using the central laboratory results, the subject should not be enrolled in the study. In addition, if the central laboratory test results do not confirm inclusion criteria 6, the subject should not be enrolled.
- •7.Have the following laboratory values during the screening period of the trial: Alkaline phosphatase = 3.0 x upper limit of normal; AST
- •(SGOT) and ALT (SGPT) = 5.0 x upper limit of normal; Hg = 9.0 g/dl (if female) or = 10.0 g/dl (if male); have calculated creatinine clearance at the time of screening = 50 mL/min.
- •8.Be clinically stable with no signs or symptoms of active infection at the time of entry into the study.
- •9.Be highly unlikely to become pregnant or to impregnate a partner.
- •Extension study:
- •In order to be eligible for participation in the study extension at the Week 96 visit, the subject must:
- •1.Have completed the Week 96 visit.
- •2.Be considered, in the opinion of the investigator, to have derived benefit from study participation through Week 96.
- •3.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.
- •4.Understand the procedures in the study extension and provide written informed consent to enter the study extension, thus continuing for approximately 2 years beyond the base study.
- •Are the trial subjects under 18? no
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 this 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 (MK-1439, lamivudine, and/or tenofovir) as defined below:
- •a)Resistance to MK-1439 for the purpose of this study is considered to include mutant viruses containing any of the following NNRTI-associated mutations: L100I, K101E, K101P, K103S, V106A, V106I, V106M, V108I, E138K, E138A, E138G, E138Q, E138R, V179L, Y181I, Y181V, Y188C, Y188H, Y188L, G190S, H221Y, P225H, F227C, F227V, F227L, M230I and M230L.
- •b)Any double or triple NNRTI mutation that includes mutations from the above in combination with K103N, Y181C, or G190A.
- •c)Resistance to lamivudine or tenofovir for the purpose of this study is considered to include following NRTI-associated mutations: M41L, A62V, K65R, D67N, K70E, K70R, L74V, V75I, F77L, Y115F, F116Y, Q151M, M184I, M184V, L210W. T215F, T215Y, K219E, and K219Q as well as the T69S insertion complex.
- •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 during the course of the study.
- •6.Has any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial.
- •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 drug 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.
- •11.Is pregnant, breastfeeding, or expecting to conceive.
- •12.Is female and 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.
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