Recombinant Lactoferrin to Reduce Immune Activation and Coagulation Among HIV Positive Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Number of Participants Taking Medication as Assigned
研究概览
简要总结
Our general goal is to evaluate the potential effectiveness of recombinant lactoferrin (1500mg bid) for reducing inflammation among HIV positive participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive participants receiving Antiretroviral Therapy (ART) for >1 year
- •HIV RNA level <200 copies/mL for at least 6 months (≥2 separate values)
- •Age >40 years
排除标准
- •Prior cardiovascular disease or stroke
- •Rheumatologic Diseases
- •Chronic kidney disease, stage IV or V (creatinine clearance <30 mL/min/1.73m2)
- •Cirrhosis or end-stage liver disease
研究组 & 干预措施
Recombinant Lactoferrin
Recombinant lactoferrin will be administered by mouth twice daily
干预措施: Recombinant Lactoferrin (Drug)
Placebo
Matched placebo will be administered by mouth twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Taking Medication as Assigned
时间窗: 3 months
Number of participants taking medication as assigned at 3 months
Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event
时间窗: During 3 months on Lactoferrin or Placebo (and following washout period)
Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)
IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)
时间窗: 3 months (Baseline to Month 3 or Month 5 to Month 8)
The IL-6 \& D-dimer score is defined as: 0. 33\*log2 IL-6 + 0.16\*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 \& D-dimer score are interpreted as "HR(event) per doubling of IL-6 and D-dimer", or "HR(event) per 20% increase in IL-6 and D-dimer"; the score itself is unitless. Among the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5. Higher scores are worse.
次要结局
未报告次要终点
研究者
Jason Baker
Associate Professor of Medicine
Hennepin Healthcare Research Institute