Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS - NCT00737204-10032 (Clinical Trial 237329)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy237329.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10032 |
| Conditions: |
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HIV Infections - Fatigue |
| Purpose: |
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This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is
effective in reducing fatigue in adults with HIV/AIDS.
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| Study summary: |
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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: |
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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 |
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| Study is available at: |
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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 |
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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.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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