A PHASE 2B/3, RANDOMIZED, DOUBLE-BLIND, DOSE CONFIRMING STUDY OF THE SAFETY,

2B/3 期、随机、双盲、剂量确认安全性研究，

• 批准号: 7952137
• 负责人: JUAN C SARRIA
• 金额: $ 0.09万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952137
• 关键词: Anti-Retroviral Agents; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Cytidine; Disease; Dose; Double-Blind Method; Failure; Funding; Grant; HIV; HIV-1; Infection; Institution; Lamivudine; Morbidity - disease rate; Mutation; New Agents; Nucleosides; Patients; Pharmaceutical Preparations; Phase; Placebos; Plasma; RNA; RNA-Directed DNA Polymerase; Randomized; Research; Research Personnel; Resistance; Resources; Reverse Transcriptase Inhibitors; Safety; Source; Therapeutic; United States National Institutes of Health; Upper arm; Viral; analog; antiretroviral therapy; experience; improved; mortality; safety study

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The advent of combination antiretroviral therapy (ART) has significantly decreased the morbidity and mortality associated with HIV disease. However, many patients who achieve undetectable plasma HIV-1 RNA levels following treatment ultimately experience virologic failure requiring a change in their ART. Newer agents, particularly those with activity against viral isolates with resistance to currently available drugs, are clearly needed in order to extend the armory of products available to treat patients with HIV-1 infection. The nucleoside reverse transcriptase inhibitors (NRTIs) are important components of the current strategies to control HIV-1 infection. A new, well tolerated cytidine analog with an improved resistance, efficacy and safety profile would make a substantial addition to the therapeutic options for treatment experienced patients with HIV-1 infection. The objective of the study is to compare the antiretroviral efficacy of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients with the M184V/I mutation in reverse transcriptase.? To compare the safety and tolerability of ATC to lamivudine (3TC) in treatment experienced, HIV-1 infected patients. Patients will be randomized to one of 3 Arms to receive for up to 48 weeks in a 1:1:1 ratio: A: apricitabine 800mg BID (plus lamivudine placebo), orally B: apricitabine 1200mg BID (plus lamivudine placebo), orally C: lamivudine 150mg BID (plus apricitabine placebo), orally This study will help determine if this treatment option is effective.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 联合抗逆转录病毒疗法（ART）的出现大大降低了与艾滋病毒疾病相关的发病率和死亡率。然而，许多患者谁达到不可检测的血浆HIV-1 RNA水平治疗后，最终经历病毒学失败，需要改变他们的ART。较新的代理，特别是那些对目前可用的药物耐药的病毒分离株的活性，显然是需要的，以扩大军械库的产品可用于治疗HIV-1感染的患者。核苷类逆转录酶抑制剂（NRTIs）是目前控制HIV-1感染策略的重要组成部分。一种新的，耐受性良好的胞苷类似物，具有改善的耐药性，疗效和安全性，将大大增加治疗经验丰富的HIV-1感染患者的治疗选择。本研究的目的是比较ATC与拉米夫定（3 TC）在治疗经验丰富的逆转录酶M184 V/I突变的HIV-1感染患者中的抗逆转录病毒疗效。比较ATC与拉米夫定（3 TC）在有治疗经验的HIV-1感染患者中的安全性和耐受性。患者将以1：1：1的比例随机分配至3组之一，接受长达48周的治疗： A：阿西他滨800 mg BID（加拉米夫定安慰剂），口服 B：阿西他滨1200 mg BID（加拉米夫定安慰剂），口服 C：拉米夫定150 mg BID（加阿昔他滨安慰剂），口服 这项研究将有助于确定这种治疗方法是否有效。