Surrogate Marker For Tropism-A Multi-Center, Open Label, Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay
研究概览
简要总结
The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.
详细描述
The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 16 years of age (or minimum adult age as determined by local regulatory authorities or as dictated by local law) at the screening visit.
- •Have an HIV RNA ≥ 1000 copies/mL, at screening.
- •Subjects receiving another investigational antiretroviral compound through participation in a phase 3 or 4 clinical study are eligible to participate in this trial provided.
- •That the 2 investigational agents are required to offer the subject a regimen with 2 or 3 active antiretroviral drugs (i.e. one or fewer approved treatment is available to the subject due to prior resistance or intolerance),
- •Neither protocol prohibits the use of the other antiretroviral agent, AND the dosing of the two agents when used together is known AND a letter from the Pfizer clinical pharmacologists for maraviroc identifies the dose of maraviroc to be used with other investigational agents.
- •Based on screening genotypic resistance testing results the subject must be able to receive at least 3 active drugs other than maraviroc in the new OBT. This is defined as:
- •Having three drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility); or,
- •Having two drugs considered susceptible by genotype interpretation (if etravirine will be used, fewer than 3 etravirine resistance mutations will be taken as etravirine susceptibility) and be willing to include raltegravir in the OBT not having used raltegravir in the past.
排除标准
- •Potentially life threatening (Grade 4) laboratory abnormality or medical condition.
- •Severe hepatic impairment (Child-Pugh classification B or C).
- •End stage renal disease or other disease states requiring dialysis therapy.
研究组 & 干预措施
Single
干预措施: maraviroc (Drug)
Single
干预措施: Trofile Assay and HIV RNA quantification assay (Procedure)
结局指标
主要结局
Change From Baseline in Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) With R5 & Non-R5 Tropism Results From the Trofile(tm) Assay
时间窗: Baseline, Day 4, 7, 14
Spearman's correlation coefficient to assess percentage of participants achieving HIV-1 RNA with tropism
次要结局
- Change in Detectable Resistance (Genotype) and Susceptibility (Phenotype) to Drugs in the Regimen From Screening(Screening (Day -21), Baseline (Day 0), Day 14 (after addition of MVC to a failing regimen), Week 24, and time of Virologic Failure.)
- Subjects Achieving HIV-1 RNA <400 Copies/mL(Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24)
- Time to Virologic Failure(Baseline up to Week 24)
- Change in Lymphocyte Subset CD4 From Baseline(Day 1 (Baseline), Day 7, 14, 28 and Weeks 24)
- Change in Detectable Tropism From Screening(Screening (Day -21 to 0), Baseline.)
- Change in Lymphocyte Subsets; CD4 and CD8 From Screening.(Screening (Day -14 to 0), Day 1.)
- Subjects Achieving HIV-1 RNA <50 Copies/mL(Days 4, 7, 14, 28, and Weeks 8, 12, 18, and 24)
- Subjects With Virologic Failure(Baseline up to Week 24)
- Change in Detectable Tropism From Baseline(Baseline, Day 15 and Week 24/End of Study/Discontinuation)
- Number of Subjects With Susceptibility to Maraviroc(Screening (Day -21 to 0), Day 14, Week 24)
- Correlation of Mutations in gp160 and the V3 Loop and Decreased Susceptibility to Maraviroc(Screening (Day -21 to 0), Day 14, time of virologic failure, Week 24)
- Change in Lymphocyte Subset CD8 From Day 1(Day 1(Baseline), Day 7, 14, 28 and Weeks 24)
- Change in Gene Sequence in Gp-160, and the V3 Loop From Screening Visit (Day -21 to 0) to Day 14, Time of Virologic Failure (See Section 6.5.1) and Week 24(Screening (Day -21 to 0), Day 14, time of virologic failure, and Week 24)