Adding Maraviroc to the HAART Regimen of HIV-infected Patients Who Are Well Controlled, and the Effect on CD4 Lymphocyte Counts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in absolute CD4 lymphocyte count after addition of maraviroc for 12 months to the subject's current highly active antiretroviral therapy (HAART) regimen.
研究概览
简要总结
Many patients on Highly Active Antiretroviral Therapy (HAART) are able to achieve a sustained response with viral loads becoming undetectable and staying undetectable, but do not have an increase in their CD4 counts to levels greater than 500. Adding maraviroc to the treatment regimen of these patients may result in an increase in their CD4 counts. As the patient would be continuing their prior regimen, they will likely continue with full control of viral replication.
详细描述
This is a prospective, open-label, non-controlled, non-randomized, single center study of the effect of adding the antiretroviral Maraviroc to the antiretroviral treatment regimen (HAART)of patients who have achieved a sustained virologic response to HAART but have had a sub-adequate immunologic response to treatment. Patients who have had a full virologic response (as defined by HIV-1 viral loads of < 48 copies/mL) for 12 months or more are defined as having a sub-adequate immunologic response if their CD4 lymphocyte count has not gone above 500.
This pilot study will contain up to 30 patients who will be followed over a period of 12 months starting from the date of enrollment and addition of maraviroc to their current highly active antiretroviral therapy regimen. The main outcome to be followed is the CD4 lymphocyte counts at baseline and after 12 months of treatment with the addition of maraviroc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •HIV-1 positive.
- •Receiving highly active antiretroviral therapy (HAART).
- •HIV-1 viral load of < 48 copies for 12 months or more.
- •CD4 lymphocyte count that has not gone above
排除标准
- •Severe hepatic impairment (cirrhosis) or active Hepatitis C with liver transaminases > 5 times normal.
- •Severe renal impairment (creatinine clearance < 30 ml/min) or end-stage renal disease (ESRD) who are taking potent CYP3A4 inhibitors or inducers.
- •Receiving certain necessary medications that have the potential for serious drug-drug interactions with maraviroc. -
研究组 & 干预措施
Maraviroc
干预措施: Maraviroc (Drug)
结局指标
主要结局
Change in absolute CD4 lymphocyte count after addition of maraviroc for 12 months to the subject's current highly active antiretroviral therapy (HAART) regimen.
时间窗: one year
次要结局
未报告次要终点