VIRAL DYNAMICS AND PHARMACOKINETICS OF TDF AND ABC MONOTHERAPY VERSUS THE COMB

TDF 和 ABC 单疗法与梳子疗法的病毒动力学和药代动力学

• 批准号: 7951035
• 负责人: CATHERINE A DIAMOND
• 金额: $ 0.41万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951035
• 关键词: Cell membrane; Clinical Research; Comb animal structure; Computer Retrieval of Information on Scientific Projects Database; Data; Drug Kinetics; Enzymes; Funding; Grant; HIV; Institution; Lamivudine; Messenger RNA; Mono-S; Mutation; Phase; RNA; Relative (related person); Research; Research Personnel; Resources; Reverse Transcriptase Polymerase Chain Reaction; Source; Tenofovir; Toxic effect; Transcript; Treatment Protocols; United States National Institutes of Health; Viral; abacavir; efavirenz; nucleoside analog; response

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. Primary Objectives 1. To evaluate the relative potencies of two monotherapy regimens (Tenofovir(TDF) alone vs. Abacavir(ABC) alone) compared to a dual NRTI regimen of TDF + ABC as assessed by the short-term virologic response (slope of the phase I viral decay and change in HIV RNA at day 7). 2. To compare the plasma and intracellular PK data of the two monotherapy regimens compared to the dual NRTI regimen. Secondary Objectives 1. To evaluate the change in cellular regulatory enzymes involved with nucleoside analogue transport across cell membranes as assessed by RT-PCR of specific mRNA transcripts after 21 days of TDF+ABC exposure. 2. To determine if NRTI-associated mutations emerge after 7 days of ABC or TDF monotherapy or after 7 days of dual NRTI therapy with ABC + TDF. 3. To compare the relative viral potency of TDF monotherapy versus ABC monotherapy. 4. To evaluate the long-term viral response to Efavirenz (EFV) + ABC + 3TC after two 7-day sequences of mono/dual-therapy. 5. To evaluate the relative toxicities of the two monotherapy treatment regimens.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此，可以在其他清晰的条目中表示。列出的机构是 对于中心，这不一定是调查员的机构。 主要目标 1。与TDF + ABC的双NRTI治疗方案相比，与单独的ABC（ABC）相对评估两种单一治疗方案（Tenofovir（TDF）（TDF））的相对功能，这是通过短期病毒学反应评估的（I阶段I在第7天，病毒衰减和HIV RNA的变化）。 2。比较与双NRTI方案相比，两种单一疗法方案的血浆和细胞内PK数据。 次要目标 1。为了评估与核苷类似物在TDF+ABC暴露21天后通过RT-PCR评估的与核苷类模拟转运有关的细胞调节酶的变化。 2。确定ABC或TDF单一疗法7天后，还是在双重NRTI治疗ABC + TDF后7天后出现NRTI相关突变。 3。比较TDF单一疗法与ABC单一疗法的相对病毒效力。 4。评估两个7天单疗法序列后，对Efavirenz（EFV） + ABC + 3TC的长期病毒反应。 5。评估两种单药治疗方案的相对毒性。