Modafinil Treatment for Fatigue in HIV+ Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Role Function Scale Outcome
研究概览
简要总结
This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, 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. This study will determine if modafinil can reduce fatigue in HIV/AIDS patients.
This study will last 12 weeks. Participants will be randomly assigned to receive either modafinil or placebo daily for 4 weeks. Participants who show an improvement in symptoms will receive modafinil for an additional 8 weeks. Participants who do not respond to modafinil will have the opportunity to receive other drug treatments. 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.
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
- Double (Participant, 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 [O.I.] 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 [TSH] 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 Rating Scale (HAM-D) >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
Modafinil
Participants will take modafinil for 4 weeks.
干预措施: Modafinil (Drug)
Placebo
Participants will take placebo for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Role Function Scale Outcome
时间窗: Measured at baseline and Week 4
The Role Function Scale includes 10 items drawn from the Short Form 36-item Health 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 to 50.
Fatigue Severity Scale (FSS)
时间窗: Measured at baseline and Week 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 to 63, with a higher value indicating greater impairment due to fatigue.
次要结局
- CD4 Cell Count(Measured at baseline and Week 4)
- HIV RNA Viral Load(Measured at baseline and Week 4)