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Trial record 75 of 239 for:    (armodafinil)

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

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ClinicalTrials.gov Identifier: NCT00118378
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 9, 2014
Last Update Posted : May 10, 2017
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: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions HIV Infections
Fatigue
Interventions Drug: Modafinil
Drug: Placebo
Enrollment 115
Recruitment Details Patients were enrolled from January 2005 until December 2008.
Pre-assignment Details  
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil. Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
Period Title: Overall Study
Started 62 53
Completed 60 45
Not Completed 2 8
Arm/Group Title Modafinil Placebo Total
Hide Arm/Group Description Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil. Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered. Total of all reporting groups
Overall Number of Baseline Participants 62 53 115
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 53 participants 115 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
  96.8%
53
 100.0%
113
  98.3%
>=65 years
2
   3.2%
0
   0.0%
2
   1.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 53 participants 115 participants
45.94  (9.35) 45.74  (8.57) 45.84  (8.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 53 participants 115 participants
Female
8
  12.9%
7
  13.2%
15
  13.0%
Male
54
  87.1%
46
  86.8%
100
  87.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 62 participants 53 participants 115 participants
62 53 115
1.Primary Outcome
Title Fatigue Severity Scale (FSS)
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 to 63, with a higher value indicating greater impairment due to fatigue.
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 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:
Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
Overall Number of Participants Analyzed 62 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline FSS 52  (7) 52  (6)
Week 4 FSS 34  (5) 43  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modafinil, 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 Outcome
Hide Description 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.
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 10 dropouts (2 on Modafinil and 8 on Placebo), using the last data point brought forward.
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:
Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
Overall Number of Participants Analyzed 62 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Role Function Scale 39  (7) 36  (6)
Week 4 Role Function Scale 22  (9) 27  (11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modafinil, 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]
3.Secondary Outcome
Title CD4 Cell Count
Hide Description 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.
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 Modafinil Placebo
Hide Arm/Group Description:
Participants randomized to modafinil for 4 weeks.
Participants randomized to placebo for 4 weeks.
Overall Number of Participants Analyzed 58 44
Mean (Standard Deviation)
Unit of Measure: Cells/mcL
Baseline CD4 cell count 481  (249) 459  (257)
Week 4 CD4 cell count 466  (244) 482  (240)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modafinil, Placebo
Comments Week 4 CD4 cell count
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .150
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title HIV RNA 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 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.
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 Modafinil Placebo
Hide Arm/Group Description:
Participants randomized to modafinil for 4 weeks.
Participants randomized to placebo for 4 weeks.
Overall Number of Participants Analyzed 58 44
Mean (Standard Deviation)
Unit of Measure: Log10 copies/mL
Baseline Log10 Viral Load 2.53  (1.2) 2.41  (1.2)
Week 4 Log10 Viral load 2.31  (1.0) 2.30  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modafinil, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .459
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Weeks 1-4 during the double-blind phase of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil. Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
All-Cause Mortality
Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/62 (0.00%)   0/53 (0.00%) 
This study was conducted at a single site in an urban setting where most patients have good access to medical care. Women were under-represented despite outreach efforts.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Judith Rabkin
Organization: New York State Psychiatric Institute
Phone: 212.543.5762
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00118378     History of Changes
Other Study ID Numbers: #4839
R01MH072383-01 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASNM
First Submitted: July 6, 2005
First Posted: July 11, 2005
Results First Submitted: January 3, 2012
Results First Posted: June 9, 2014
Last Update Posted: May 10, 2017