NCT00885664已完成4 期
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced 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
- 60
- 试验地点
- 1
- 主要终点
- Symptom Score
研究概览
简要总结
The purposes of this study are:
- To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects.
- To determine whether these side effects can be related to greater activation of the immune system.
详细描述
- To compare the incidence and severity of self-reported symptoms in persons with CD4 counts <100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy.
- To determine the relationship between self-reported symptoms and levels of T cells, HIV RNA, activation marker cytokines including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10 and other cytokines as measured before and after the initiation of antiretroviral therapy.
- To determine the relationship between antiretroviral drug trough levels (estimated drug concentrations) and the incidence and severity of self-reported symptoms in persons initiating antiretroviral therapy.
- To determine the relationship between adverse events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
- To determine the relationship between clinical events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Age > 18 years
- •Diagnosis of HIV infection.
- •Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.
排除标准
- •Blinded drug treatment.
- •Active untreated serious infection within 14 days of enrollment that in the opinion of the investigator would affect the subject's participation and/or safety in the study.
- •Known resistance to proposed new HIV regimen or components of regimen.
- •Requirement for drug therapy with known contraindication with proposed new antiretroviral therapy (see Prohibited and Precautionary Medications below)
- •Pregnancy or breast feeding.
- •Liver enzyme abnormalities on screening. Patients who have symptomatic Grade 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase or Grade > 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase will be excluded. Patients who have asymptomatic grade 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase may be included in the study at the discretion of the primary physician in consultation with the principal or senior investigator. Patients with grade 3 elevations of liver function tests who are co-infected with hepatitis B or hepatitis C may be included in the study at the discretion of the primary care physician in consultation with the primary or senior investigator provided that they do not have signs or symptoms of clinical hepatitis. Signs of clinical hepatitis include: icterus, abdominal tenderness and hepatosplenomegaly. Symptoms of clinical hepatitis include: fever, abdominal pain, anorexia, nausea, vomiting, fatigue, malaise, and myalgia.
- •Decreased creatinine clearance at the time of screening. Patients with a creatinine clearance of <50mL/min as calculated by the Cockcroft-Gault method should be excluded from study entry. The Cockcroft-Gault method is defined on page
- •Other Grade ≥3 lab abnormalities. For any other laboratory abnormalities of grade 3 or higher, patients may be included or excluded from the study at the discretion of the primary care physician in consultation with the primary or senior investigator.
研究组 & 干预措施
Truvada/Kaletra CD4<100
Other
All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4<100 cells/cu mm
干预措施: Truvada (tenofovir/emtricitabine) (Drug)
Truvada/Kaletra CD4<100
Other
All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4<100 cells/cu mm
干预措施: Kaletra (lopinavir/ritonavir) (Drug)
Truvada/Kaletra CD4>/=100
Other
All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4>/=100 cells/cu mm
干预措施: Truvada (tenofovir/emtricitabine) (Drug)
Truvada/Kaletra CD4>/=100
Other
All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4>/=100 cells/cu mm
干预措施: Kaletra (lopinavir/ritonavir) (Drug)
结局指标
主要结局
Symptom Score
时间窗: Week 4
AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale.
次要结局
- SF-12 Physical Capacity Score(4 weeks)
- SF-12 Mental Capacity Score(4 weeks)
- IL-1 Beta(4 weeks)
- IL-4(4 weeks)
- IL-6(4 weeks)
- IL-7(4 weeks)
- IL-8(4 weeks)
- IL-10(4 weeks)
- TNF Alpha(4 weeks)
- INF Gamma(4 weeks)
研究者
Carl J. Fichtenbaum
Professor
University of Cincinnati
研究点 (1)
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