Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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;   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
  Hide Participant Flow

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
  Hide 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
  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
  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


  More Information
  Hide 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
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
Health Authority: United States: Federal Government