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Effectiveness of Armodafinil 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:
NCT00737204
First received: August 14, 2008
Last updated: June 11, 2014
Last verified: March 2013
Results First Received: March 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: HIV Infections
Fatigue
Interventions: Drug: Armodafinil
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 recruited from community based organizations and healthcare clinics that provide services to persons with HIV, by placing flyers on bulletin boards and in waiting areas.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 114 patients were screened for eligibility, 25 had medical or psychiatric exclusion criteria, 7 were active substance users, 4 were taking stimulants, 3 were not clinically fatigued, 5 declined participation, and 70 were randomized. Of the 70, 64 completed the 4-week trial.

Reporting Groups
  Description
Armodafinil Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil. Starting dose of armodafinil is 50 mg/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 250 mg/day.
Placebo Participants will receive a placebo pill (matching the active medication) for 4 weeks, then a 16-week course of armodafinil. Starting dose of is one placebo pill/day, increased weekly in the absence of clinical response and dose-limiting side effects to a maximum of 5 placebo pills/day.

Participant Flow:   Overall Study
    Armodafinil   Placebo
STARTED   36   34 
COMPLETED   36   28 
NOT COMPLETED   0   6 



  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
Armodafinil Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
Placebo Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
Total Total of all reporting groups

Baseline Measures
   Armodafinil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 36   34   70 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   36   34   70 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 46  (8.7)   46  (8.2)   46  (8.4) 
Gender 
[Units: Participants]
     
Female   5   4   9 
Male   31   30   61 
Region of Enrollment 
[Units: Participants]
     
United States   36   34   70 


  Outcome Measures
  Show All Outcome Measures

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

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

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

4.  Secondary:   HIV 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
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  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: Judith G. Rabkin, Ph.D., M.P.H.
Organization: New York State Psychiatric Institute
phone: (646) 774-8075
e-mail: jgr1@columbia.edu


Publications of Results:
Other Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00737204     History of Changes
Other Study ID Numbers: #4839/5892R
R01MH072383-02 ( US NIH Grant/Contract Award Number )
Study First Received: August 14, 2008
Results First Received: March 13, 2013
Last Updated: June 11, 2014
Health Authority: United States: Federal Government