NCT00264290已完成4 期
Valganciclovir to Reduce T Cell Activation in HIV Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.
研究概览
简要总结
The purpose of this study is to determine whether treatment with valganciclovir decreases T cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV) co-infection, potentially improving immune responses 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
- •Infection with HIV >1 year in duration.
- •Cytomegalovirus (CMV) antibody positive.
- •All Cluster of Differentiation 4 (CD4)+ T cell counts in the last year and at screening <350 cells/mm3
- •On a stable highly addictive antiretroviral therapy (HAART) regimen (DHHS definition) for the preceding 6 months.
- •90% adherence to antiretroviral therapy within the preceding 30 days.
- •Females of childbearing potential must have a negative serum pregnancy test at screening and all subjects must agree to use a double-barrier method of contraception throughout the study period.
- •Screening %Cluster of differentiation 38 (CD38)+ Human leukocyte antigen-D-related (HLA-DR)+ Cluster of differentiation 8 (CD8)+ T cells >10%
排除标准
- •Patients intending to modify antiretroviral therapy in the next 16 weeks.
- •Serious illness requiring hospitalization or parental antibiotics within preceding 3 months.
- •Evidence of active symptomatic CMV end-organ disease.
- •Treatment with valganciclovir or ganciclovir in the past 30 days.
- •Concurrent treatment with immunomodulatory drugs.
- •Concurrent treatment with nephrotoxic drugs
- •Screening absolute neutrophil count <1,000 cells/mm3, platelet count <100,000 cells/mm3, hemoglobin < 8mg/dL, estimated creatinine clearance <50 mL/minute.
- •Men who are considering having children will also be excluded given potential effects of valganciclovir on spermatogenesis.
- •Pregnant or breastfeeding women
研究组 & 干预措施
Valganciclovir
Experimental
900mg PO qd
干预措施: Valganciclovir (Drug)
Placebo
Placebo Comparator
900mg PO qd
干预措施: Placebo (Drug)
结局指标
主要结局
Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8.
时间窗: Baseline, 8 weeks
The percentage of activated (CD38+ HLA-DR+) CD8+ T cells was measured on fresh whole blood at screening/baseline. T cell activation was measured on peripheral blood mononuclear cells (PBMCs)in batch at the end of the study.
次要结局
- Change in CMV DNA Shedding From Baseline to Week 8.(baseline and week 8)
- Change in Cluster of Differentiation 4 (CD4) Counts at Week 8(Baseline and week 8)
- Change in Percent of CD38+HLA-DR+ CD8+ T Cells After a 4-week Washout Period(Baseline and Week 12)
- Number of Participants With Positive CMV DNA After a 4-week Washout Period(Week 12)
- Change in CD4 Counts After a 4-week Washout Period(Week 12)
研究者
研究点 (1)
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