ANTIHIV ACTIVITY OF 60MG DAILY DOSE ADEFOVIR DIFIVOXIL IN HIV INFECTED PATIENTS

尽管联合抗逆转录病毒疗法的活性有所改善 在HIV感染患者中，抗病毒、免疫学和临床 这种疗法的影响似乎是不完整的，而且往往 转瞬即逝。此外，上述药物的治疗方法可能是 与显著的药物相互作用和副作用有关。 与复杂给药方案相结合的疗法也会引起 对一些需要抗逆转录病毒治疗的人群来说，这是一个挑战。 因此，新奇的鉴定和方便的管理 HIV患者联合治疗策略中的药物 感染将会有很大的好处。阿德福韦酯，一种核苷酸 逆转录酶抑制剂，已被证明在体内有效 通过减少病毒载量的能力来对抗艾滋病毒，包括 P24Ag和HIV RNA。 阿德福韦酯，每日60毫克，已用于 以前的试验，但仅作为剂量从120毫克减少到 临床上有明显的毒性或不耐受。既往临床 试验已经证明了明显的剂量依赖关系 阿德福韦酯相关不良事件。然而，没有明确的剂量 阿德福韦的抗病毒活性已建立依赖关系 临床研究剂量：每天125毫克至500毫克。这个 阿德福韦酯每日60 mg的抗病毒活性或安全性 还没有经过检查。每天60毫克的剂量有可能会 与125毫克具有相同的抗HIV效果。因此，这样做的理由 执行该方案是为了确定其是否具有抗病毒活性 阿德福韦酯的剂量比以前在 人体试验。

Despite the improved activity of combination antiretroviral therapies in patients with HIV infection, the antiviral, immunologic, and clinical impact of such therapies appears to be incomplete and is often transient. In addition, treatment with the agents noted above may be associated with significant drug interactions and side effects. Combination therapies with complicated administration regimens also pose a challenge to some populations requiring antiretroviral therapy. Therefore, the identification of novel and conveniently administered agents in combination strategies for treating patients with HIV infection would be of great benefit. Adefovir dipivoxil, a nucleotide reverse transcriptase inhibitor, has been shown to be effective in vivo against HIV by its ability to reduce viral load measurements including p24Ag and HIV RNA. Adefovir dipivoxil at a dose of 60 mg daily has been utilized in previous trials but only as a dose reduction from 120 mg in response to clinically significant toxicities or intolerance. Previous clinical trials have demonstrated a clear dose-dependent relationship for adefovir dipivoxil related adverse events. However, no clear dose dependence has been established for the antiviral activity of adefovir dipivoxil at the doses clinically studied: 125 mg to 500 mg daily. The antiviral activity or safety profile of adefovir dipivoxil 60 mg daily has not been examined. It is possible that a daily dose of 60 mg has the same anti-HIV effect as 125 mg. Therefore, the rationale for conducting this protocol is to determine if there is antiviral activity of adefovir dipivoxil at a lower dose than those tested previously in human trials.