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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00118378
First received: July 6, 2005
Last updated: June 6, 2014
Last verified: March 2013
Results First Received: January 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Fatigue
Interventions: Drug: Modafinil
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled from January 2005 until December 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Modafinil   Placebo
STARTED   62   53 
COMPLETED   60   45 
NOT COMPLETED   2   8 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Modafinil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   53   115 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   60   53   113 
>=65 years   2   0   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.94  (9.35)   45.74  (8.57)   45.84  (8.96) 
Gender 
[Units: Participants]
     
Female   8   7   15 
Male   54   46   100 
Region of Enrollment 
[Units: Participants]
     
United States   62   53   115 


  Outcome Measures
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1.  Primary:   Fatigue Severity Scale (FSS)   [ Time Frame: Measured at baseline and Week 4 ]

2.  Primary:   Role Function Scale Outcome   [ Time Frame: Measured at baseline and Week 4 ]

3.  Secondary:   CD4 Cell Count   [ Time Frame: Measured at baseline and Week 4 ]
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Measure Type Secondary
Measure Title CD4 Cell Count
Measure 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  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Results were included for patients on whom baseline and week 4 labs were drawn.

Reporting Groups
  Description
Modafinil Participants randomized to modafinil for 4 weeks.
Placebo Participants randomized to placebo for 4 weeks.

Measured Values
   Modafinil   Placebo 
Participants Analyzed 
[Units: Participants]
 58   44 
CD4 Cell Count 
[Units: Cells/mcL]
Mean (Standard Deviation)
   
Baseline CD4 cell count   481  (249)   459  (257) 
Week 4 CD4 cell count   466  (244)   482  (240) 


Statistical Analysis 1 for CD4 Cell Count
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Paired t-tests
P Value [4] >= .24
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
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[3] Other relevant method information, such as adjustments or degrees of freedom:
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[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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4.  Secondary:   HIV RNA Viral Load   [ Time Frame: Measured at baseline and Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: jgr1@columbia.edu


Publications of Results:
Other Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00118378     History of Changes
Other Study ID Numbers: #4839
R01MH072383-01 ( US NIH Grant/Contract Award Number )
DAHBR 9A-ASNM
Study First Received: July 6, 2005
Results First Received: January 3, 2012
Last Updated: June 6, 2014