Trial Outcomes & Findings for Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS (NCT NCT00118378)

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 to 63, with a higher value indicating greater impairment due to fatigue.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

115 participants

Primary outcome timeframe

Measured at baseline and Week 4

Results posted on

2017-05-10

Participant Flow

Patients were enrolled from January 2005 until December 2008.

Participant milestones

Participant milestones
Measure	Modafinil Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.	Placebo Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
Overall Study STARTED	62	53
Overall Study COMPLETED	60	45
Overall Study NOT COMPLETED	2	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modafinil n=62 Participants Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.	Placebo n=53 Participants Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.	Total n=115 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	60 Participants n=5 Participants	53 Participants n=7 Participants	113 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	45.94 years STANDARD_DEVIATION 9.35 • n=5 Participants	45.74 years STANDARD_DEVIATION 8.57 • n=7 Participants	45.84 years STANDARD_DEVIATION 8.96 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	46 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment United States	62 participants n=5 Participants	53 participants n=7 Participants	115 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and Week 4

Population: The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.

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.

Outcome measures

Outcome measures
Measure	Modafinil n=62 Participants Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.	Placebo n=53 Participants Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
Fatigue Severity Scale (FSS) Baseline FSS	52 units on a scale Standard Deviation 7	52 units on a scale Standard Deviation 6
Fatigue Severity Scale (FSS) Week 4 FSS	34 units on a scale Standard Deviation 5	43 units on a scale Standard Deviation 13

PRIMARY outcome

Timeframe: Measured at baseline and Week 4

Population: The WEEK 4 outcome analyses are based on an intention to treat sample which includes the 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.

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.

Outcome measures

Outcome measures
Measure	Modafinil n=62 Participants Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.	Placebo n=53 Participants Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
Role Function Scale Outcome Week 4 Role Function Scale	22 units on a scale Standard Deviation 9	27 units on a scale Standard Deviation 11
Role Function Scale Outcome Baseline Role Function Scale	39 units on a scale Standard Deviation 7	36 units on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: Measured at baseline and Week 4

Population: 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 functioning. Blood was 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

Outcome measures
Measure	Modafinil n=58 Participants Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.	Placebo n=44 Participants Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
CD4 Cell Count Week 4 CD4 cell count	466 Cells/mcL Standard Deviation 244	482 Cells/mcL Standard Deviation 240
CD4 Cell Count Baseline CD4 cell count	481 Cells/mcL Standard Deviation 249	459 Cells/mcL Standard Deviation 257

SECONDARY outcome

Timeframe: Measured at baseline and Week 4

Population: 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 presented in log10. 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

Outcome measures
Measure	Modafinil n=58 Participants Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.	Placebo n=44 Participants Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
HIV RNA Viral Load Baseline Log10 Viral Load	2.53 Log10 copies/mL Standard Deviation 1.2	2.41 Log10 copies/mL Standard Deviation 1.2
HIV RNA Viral Load Week 4 Log10 Viral load	2.31 Log10 copies/mL Standard Deviation 1.0	2.30 Log10 copies/mL Standard Deviation 1.1

Adverse Events

Modafinil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Judith Rabkin

New York State Psychiatric Institute

Phone: 212.543.5762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place