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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


  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
  Show All Outcome Measures

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 ]

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:
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