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Trial record 12 of 239 for:    (armodafinil)

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

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ClinicalTrials.gov Identifier: NCT00737204
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : June 12, 2014
Last Update Posted : June 12, 2014
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infections
Fatigue
Interventions Drug: Armodafinil
Drug: Placebo
Enrollment 70
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 36 34
Completed 36 28
Not Completed 0 6
Arm/Group Title Armodafinil Placebo Total
Hide Arm/Group Description Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil. Total of all reporting groups
Overall Number of Baseline Participants 36 34 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
36
 100.0%
34
 100.0%
70
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 34 participants 70 participants
46  (8.7) 46  (8.2) 46  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 34 participants 70 participants
Female
5
  13.9%
4
  11.8%
9
  12.9%
Male
31
  86.1%
30
  88.2%
61
  87.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 36 participants 34 participants 70 participants
36 34 70
1.Primary Outcome
Title Fatigue Severity Scale(FSS) Outcome
Hide Description 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.
Time Frame Measured at baseline and Weeks 4
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
Overall Number of Participants Analyzed 36 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline FSS 52.6  (6.13) 53.1  (6.87)
Week 4 FSS 25.8  (14.23) 39.4  (14.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Role Function Scale
Hide Description 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.
Time Frame Measured at Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
Overall Number of Participants Analyzed 36 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Role Function Scale 36.2  (5.75) 37.8  (7.81)
Week 4 Role Function Scale 19.9  (8.1) 28.3  (10.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments Repeated measure analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title CD4 Cell Count
Hide Description 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.
Time Frame Measured at baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Results were included for patients on whom baseline and week 4 labs were drawn.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
Overall Number of Participants Analyzed 35 27
Mean (Standard Deviation)
Unit of Measure: Cells/mcL
Baseline CD4 cell count 502  (202) 450  (241)
Week 4 CD4 cell count 503  (224) 445  (255)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Armodafinil, Placebo
Comments Null hypothesis: CD4 levels for both the Armodafinil and Placebo groups will not change significantly between baseline and week 4.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >=.805
Comments [Not Specified]
Method Paired t-tests
Comments [Not Specified]
4.Secondary Outcome
Title HIV Viral Load
Hide Description 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.
Time Frame Measured at baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Results were included for patients on whom baseline and week 4 labs were drawn.
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description:
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
Overall Number of Participants Analyzed 36 27
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Baseline Log10 Viral Load 2.17  (0.81) 2.39  (1.13)
Week 4 Log10 Viral load 2.15  (0.87) 2.24  (1.07)
Time Frame Treatment emergent side effects were assessed at baseline and then weekly during the 4-week trial.
Adverse Event Reporting Description Each potential side effect was rated on a 0 ("No Problems" to 5 ("Severe Problems"). An increase of 2 points during the trial from the baseline score was considered an adverse event.
 
Arm/Group Title Armodafinil Placebo
Hide Arm/Group Description Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
All-Cause Mortality
Armodafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Armodafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/34 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Judith G. Rabkin, Ph.D., M.P.H.
Organization: New York State Psychiatric Institute
Phone: (646) 774-8075
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00737204     History of Changes
Other Study ID Numbers: #4839/5892R
R01MH072383-02 ( U.S. NIH Grant/Contract )
First Submitted: August 14, 2008
First Posted: August 18, 2008
Results First Submitted: March 13, 2013
Results First Posted: June 12, 2014
Last Update Posted: June 12, 2014