Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS

Phase 4

Completed

Conditions: Fatigue
HIV Infections

Interventions: Drug: Placebo
Drug: Armodafinil

Registration Number: NCT00737204

Lead Sponsor: New York State Psychiatric Institute

Brief Summary: This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

Inclusion Criteria

Ages 18-75
HIV+
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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Armodafinil	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.

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale(FSS) Outcome	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	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.

Secondary Outcome Measures

Name	Time	Method
CD4 Cell Count	Measured at baseline and Week 4	Cd4 cell count is a laboratory marker providing an indication of immune system functioning. Blood samples were drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of \>=100 cells. A higher number is associated with better immune functioning.
HIV Viral Load	Measured at baseline and Week 4	HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50 - 100,000 copies), this measure is transformed to log10 values. We entered the log10 value of 1.69 when the laboratory result stated "under 50 copies," which was the assay's lowest limit of detectability during the study.