Armodafinil Treatment for Fatigue in HIV+ Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fatigue Severity Scale(FSS) Outcome
研究概览
简要总结
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
详细描述
Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by ARVs or by the virus itself. A related study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than modafinil, will be tested on the same criteria.
Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants randomized to active medication and who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. For these participants, the study duration is 20 weeks. Participants who did not benefit from armodafinil will receive alternate treatment options. All participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. At each visit, participants will complete various tasks to determine cognitive function, and self-report scales will be used to determine symptoms of depression and fatigue. After completion of 16 weeks, participants responding to armodafinil will be transitioned to the publicly available modafinil over the course of 2 weeks.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
- •Fatigue duration for 3+ months
- •English-speaking
- •Able to give informed consent
- •Fecund women uses barrier method of contraception
排除标准
- •Primary care doctor does not approve of study participation
- •Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic infection in past month)
- •Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
- •Untreated hypothyroidism (Thyroid Stimulating Hormone over 5 IUI/mL)
- •Untreated and uncontrolled hypertension
- •Clinically significant anemia (hematocrit <30%)
- •Started testosterone or nandrolone in past 6 weeks
- •Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
- •Untreated or under-treated major depressive disorder
- •Started antidepressant medication within past 6 weeks
- •Substance abuse/dependence (past 4 months)
- •Regular and frequent cannabis use (> twice/week regularly)
- •Currently clinically significant suicidal ideation or Hamilton Depression Scale (HAM-D) score >24
- •History or current psychosis or bipolar disorder
- •Pregnant or breastfeeding
- •Significant untreated insomnia (score >3 on HAM-D insomnia items)
- •Currently taking psychostimulant medication or past nonresponse to modafinil
- •Has no alternative viable antiretroviral regimen after the current one
- •Left ventricular hypertrophy; mitral valve prolapse
研究组 & 干预措施
Armodafinil
Participants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil.
干预措施: Armodafinil (Drug)
Placebo
Participants will receive placebo pills for 4 weeks. Placebo tablets that match the 50mg active medication tablets will given following the same dosing strategy as Arm 1. The dose will be titrated from 1 placebo tablet daily to 5 tablets daily as clinically indicated. Non-responders to placebo will then be offered 16 weeks of active medication.
干预措施: Placebo (Drug)
结局指标
主要结局
Fatigue Severity Scale(FSS) Outcome
时间窗: Measured at baseline and Weeks 4
The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9-63, with a higher score indicating greater impairment due to fatigue.
Role Function Scale
时间窗: Measured at Baseline and Week 4
The Role Function Scale includes 10 items drawn from the Short Form 36-item Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10-50.
次要结局
- CD4 Cell Count(Measured at baseline and Week 4)
- HIV Viral Load(Measured at baseline and Week 4)