View Clinical Trial (Medical Research Study)

Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS - NCT00737204-10032(Clinical Trial 237329)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  New York
State:  
NY
Zip Code: 10032
Conditions: HIV Infections - Fatigue
Purpose: This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
Study summary: Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by ARVs or by the virus itself. A related study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than modafinil, will be tested on the same criteria. This study will last 18 weeks. Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. Participants who did not benefit from armodafinil will receive alternate treatment options. All participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. At each visit, participants will complete various tasks to determine cognitive function, and self-report scales will be used to determine symptoms of depression and fatigue. After completion of 16 weeks, participants responding to armodafinil will be transitioned to the publicly available modafinil over the course of 2 weeks. For information on a related study, please follow this URL: http://clinicaltrials.gov/show/NCT00118378
Criteria: Inclusion Criteria: - HIV infected - Clinically significant fatigue for at least 3 months before study entry - Able to speak English - Willing to use acceptable methods of contraception Exclusion Criteria: - Insufficient production of thyroid hormones (hypothyroidism) or untreated malfunctioning of testes or ovaries (hypogonadism) - Uncontrolled hypertension - Clinically significant anemia - Initiation of testosterone or nandrolone (a steroid) treatment within 6 weeks before study entry - Began or changed an ARV regimen within 12 weeks before study entry - Untreated major depression - Initiation of antidepressant medication within 6 weeks before study entry - Current substance abuse or dependence that may interfere with the study - Regular cannabis use - Previous or current nondrug-induced psychosis or bipolar disorder - Current use of psychostimulant medication - Previous nonresponse to an adequate trial of modafinil - Any unstable medical condition - Previously failed ARV regimens and currently on last viable ARV regimen - Pregnancy or breastfeeding - Primary care doctor does not approve of study participation
Study is available at: New York State Psychiatric Institute
New York, NY 10032
United States

Primary Contact:
Judith G. Rabkin, PhD, MPH
Email: jgr1@columbia.edu
Phone: 212-543-5762

Secondary Contact:
Judith G. Rabkin, PhD, MPH
Email: jgr1@columbia.edu
Phone: 212-543-5762
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.