Trial Outcomes & Findings for Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS (NCT NCT00737204)
NCT ID: NCT00737204
Last Updated: 2014-06-12
Results Overview
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.
COMPLETED
PHASE4
70 participants
Measured at baseline and Weeks 4
2014-06-12
Participant Flow
Patients were recruited from community based organizations and healthcare clinics that provide services to persons with HIV, by placing flyers on bulletin boards and in waiting areas.
A total of 114 patients were screened for eligibility, 25 had medical or psychiatric exclusion criteria, 7 were active substance users, 4 were taking stimulants, 3 were not clinically fatigued, 5 declined participation, and 70 were randomized. Of the 70, 64 completed the 4-week trial.
Participant milestones
| Measure |
Armodafinil
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.
|
Placebo
Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
34
|
|
Overall Study
COMPLETED
|
36
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Baseline characteristics by cohort
| Measure |
Armodafinil
n=36 Participants
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
|
Placebo
n=34 Participants
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
46 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
46 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
34 participants
n=7 Participants
|
70 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and Weeks 4Population: Of the 70 patients randomized, 64 completed the 4-week trial. Data presented are for the 70, using the last data point carried forward (intention to treat).
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.
Outcome measures
| Measure |
Armodafinil
n=36 Participants
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
|
Placebo
n=34 Participants
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
|
|---|---|---|
|
Fatigue Severity Scale(FSS) Outcome
Baseline FSS
|
52.6 units on a scale
Standard Deviation 6.13
|
53.1 units on a scale
Standard Deviation 6.87
|
|
Fatigue Severity Scale(FSS) Outcome
Week 4 FSS
|
25.8 units on a scale
Standard Deviation 14.23
|
39.4 units on a scale
Standard Deviation 14.91
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 4Population: The week 4 outcome analyses are based on an intention to treat sample, which includes the 6 dropouts, using the last data point brought forward.
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.
Outcome measures
| Measure |
Armodafinil
n=36 Participants
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
|
Placebo
n=34 Participants
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
|
|---|---|---|
|
Role Function Scale
Baseline Role Function Scale
|
36.2 units on a scale
Standard Deviation 5.75
|
37.8 units on a scale
Standard Deviation 7.81
|
|
Role Function Scale
Week 4 Role Function Scale
|
19.9 units on a scale
Standard Deviation 8.1
|
28.3 units on a scale
Standard Deviation 10.19
|
SECONDARY outcome
Timeframe: Measured at baseline and Week 4Population: Results were included for patients on whom baseline and week 4 labs were drawn.
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.
Outcome measures
| Measure |
Armodafinil
n=35 Participants
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
|
Placebo
n=27 Participants
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
|
|---|---|---|
|
CD4 Cell Count
Baseline CD4 cell count
|
502 Cells/mcL
Standard Deviation 202
|
450 Cells/mcL
Standard Deviation 241
|
|
CD4 Cell Count
Week 4 CD4 cell count
|
503 Cells/mcL
Standard Deviation 224
|
445 Cells/mcL
Standard Deviation 255
|
SECONDARY outcome
Timeframe: Measured at baseline and Week 4Population: Results were included for patients on whom baseline and week 4 labs were drawn.
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.
Outcome measures
| Measure |
Armodafinil
n=36 Participants
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
|
Placebo
n=27 Participants
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
|
|---|---|---|
|
HIV Viral Load
Baseline Log10 Viral Load
|
2.17 Log10 copies/mL
Standard Deviation 0.81
|
2.39 Log10 copies/mL
Standard Deviation 1.13
|
|
HIV Viral Load
Week 4 Log10 Viral load
|
2.15 Log10 copies/mL
Standard Deviation 0.87
|
2.24 Log10 copies/mL
Standard Deviation 1.07
|
Adverse Events
Armodafinil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Judith G. Rabkin, Ph.D., M.P.H.
New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place