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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00118378
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 9, 2014
Last Update Posted : May 10, 2017
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
Interventions: Drug: Modafinil
Drug: Placebo

  Participant Flow

  Baseline Characteristics

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
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 
[Units: Participants]
Count of 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% 
[Units: Years]
Mean (Standard Deviation)
 45.94  (9.35)   45.74  (8.57)   45.84  (8.96) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      8  12.9%      7  13.2%      15  13.0% 
Male      54  87.1%      46  86.8%      100  87.0% 
Region of Enrollment 
[Units: Participants]
United States   62   53   115 

  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

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

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

Publications of Results:
Other Publications:

Responsible Party: New York State Psychiatric Institute Identifier: NCT00118378     History of Changes
Other Study ID Numbers: #4839
R01MH072383-01 ( U.S. NIH Grant/Contract )
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