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

This study has been completed.
Sponsor:
Collaborator:
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;   Endpoint Classification: Efficacy Study;   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  
Number of Participants  
[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 ]

Measure Type Primary
Measure Title Fatigue Severity Scale (FSS)
Measure 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  
Safety Issue No  

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.
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.

Reporting Groups
  Description
Modafinil Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
Placebo Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.

Measured Values
    Modafinil     Placebo  
Number of Participants Analyzed  
[units: participants]
  62     53  
Fatigue Severity Scale (FSS)  
[units: units on a scale]
Mean ± Standard Deviation
   
Baseline FSS     52  ± 7     52  ± 6  
Week 4 FSS     34  ± 5     43  ± 13  


Statistical Analysis 1 for Fatigue Severity Scale (FSS)
Groups [1] All groups
Method [2] ANCOVA
P Value [3] < 0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Primary
Measure Title Role Function Scale Outcome
Measure 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  
Safety Issue No  

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.
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.

Reporting Groups
  Description
Modafinil Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
Placebo Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.

Measured Values
    Modafinil     Placebo  
Number of Participants Analyzed  
[units: participants]
  62     53  
Role Function Scale Outcome  
[units: units on a scale]
Mean ± Standard Deviation
   
Baseline Role Function Scale     39  ± 7     36  ± 6  
Week 4 Role Function Scale     22  ± 9     27  ± 11  


Statistical Analysis 1 for Role Function Scale Outcome
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

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  
Safety Issue Yes  

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  
Number of 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
Method [2] Paired t-tests
P Value [3] >= .24
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



4.  Secondary:   HIV RNA Viral Load   [ Time Frame: Measured at baseline and Week 4 ]

Measure Type Secondary
Measure Title HIV RNA Viral Load
Measure 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  
Safety Issue Yes  

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  
Number of Participants Analyzed  
[units: participants]
  58     44  
HIV RNA Viral Load  
[units: Log10 copies/mL]
Mean ± Standard Deviation
   
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  


Statistical Analysis 1 for HIV RNA Viral Load
Groups [1] All groups
Method [2] Paired t-tests
P Value [3] .052
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.




  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:
Rabkin JG, McElhiney M, Rabkin R, McGrath P. Modafinil treatment for fatigue in HIV/AIDS: A randomized placebo-ctontrolled study. J. Clinical Psychiatry 2010; 71:707-715

Other Publications:
Publications automatically indexed to this study:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00118378     History of Changes
Other Study ID Numbers: #4839, R01MH072383-01, DAHBR 9A-ASNM
Study First Received: July 6, 2005
Results First Received: January 3, 2012
Last Updated: June 6, 2014
Health Authority: United States: Federal Government