Raltegravir Intensification in Antiretroviral-treated Patients Exhibiting a Suboptimal CD4+ T Cell Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.
研究概览
简要总结
The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable antiretroviral therapy for at least 12 months
- •Screening CD4+ T cell count < 350 cells/mm3
- •All available CD4+ T cell counts in the last year and at screening < 350 cells/mm3
- •Screening plasma HIV RNA levels below level of detection (< 50 copies RNA/mL using Roche Amplicor or < 75 copies/mL using Bayer bDNA or < 40 copies/mL using Abbott RT-PCR), and all available determinations in past 12 months also below level of detection (isolated single values > 75 but < 1000 copies/mL will be allowed if they were preceded and followed by undetectable viral load determinations).
- •>90% adherence to therapy within the preceding 30 days, as determined by self-report
- •Both male and female adult (at least 18 years old) subjects are eligible. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
排除标准
- •Patients who are intending to modify antiretroviral therapy in the next 24 weeks for any reason
- •Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
- •**Any vaccination 2 weeks prior to baseline (day 0) visit and throughout the study period
- •Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in past 16 weeks
- •Concurrent treatment with phenobarbital, phenytoin, or rifampin.
- •Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute
- •Pregnant or breastfeeding women
研究组 & 干预措施
Raltegravir
For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
干预措施: Raltegravir (Drug)
Placebo
For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants in Each Group (Study Drug vs. Placebo) With Undetectable Plasma HIV-1 RNA, as Measured by an Ultra-sensitive Assay With a Limit of Detection of 1 Copy/mL at Week 12.
时间窗: Week 12
次要结局
- Change in Percentage of Activated CD8+ T Cells (CD8+ T Cells That Co-express CD38 and HLA-DR) From Baseline to Week 24(Baseline and Week 24)