Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
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Purpose
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Fatigue |
Drug: Armodafinil |
Phase 4 |
| 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 |
| Official Title: | Armodafinil Treatment for Fatigue in HIV+ Patients |
- Fatigue severity scale outcome [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
- Role function scale outcome [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
- CD4 cell count [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
- HIV viral load [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
- Hamilton rating scale for depression [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
- Beck Depression Inventory II [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
- Cognitive function [ Time Frame: Measured at baseline and Weeks 4 and 12 ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | June 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1. Armodafinil, responsive
Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
|
Drug: Armodafinil
Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
Other Name: Nuvigil
|
|
Placebo Comparator: 2. Placebo, Armodafinil
Participants will receive a placebo pill for 4 weeks, then a 16-week course of armodafinil.
|
Drug: Armodafinil
Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
Other Name: Nuvigil
|
|
Active Comparator: 3. Armodafinil, nonresponsive
Participants will receive armodafinil for 4 weeks. If nonresponsive, participants will be offered 12 weeks of an alternative treatment.
|
Drug: Armodafinil
Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
Other Name: Nuvigil
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 18-75
- HIV+
- Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale [MOS Scale])
- Fatigue duration for 3+ months
- English-speaking
- Able to give informed consent
- Fecund women uses barrier method of contraception
Exclusion Criteria:
- Primary care doctor does not approve of study participation
- Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic infection in past month)
- Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
- Untreated hypothyroidism (Thyroid Stimulating Hormone over 5 IUI/mL)
- Untreated and uncontrolled hypertension
- Clinically significant anemia (hematocrit <30%)
- Started testosterone or nandrolone in past 6 weeks
- Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
- Untreated or under-treated major depressive disorder
- Started antidepressant medication within past 6 weeks
- Substance abuse/dependence (past 4 months)
- Regular and frequent cannabis use (> twice/week regularly)
- Currently clinically significant suicidal ideation or Hamilton Depression Scale (HAM-D) score >24
- History or current psychosis or bipolar disorder
- Pregnant or breastfeeding
- Significant untreated insomnia (score >3 on HAM-D insomnia items)
- Currently taking psychostimulant medication or past nonresponse to modafinil
- Has no alternative viable antiretroviral regimen after the current one
- Left ventricular hypertrophy; mitral valve prolapse
Contacts and Locations| United States, New York | |
| New York State Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Judith G. Rabkin, Phd, MPH | Columbia University |
More Information
Publications:
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00737204 History of Changes |
| Other Study ID Numbers: | #4839/5892R, R01MH072383-02, DAHBR 9A-ASNK |
| Study First Received: | August 14, 2008 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by New York State Psychiatric Institute:
|
HIV AIDS Armodafinil Depression |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Fatigue Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Slow Virus Diseases Signs and Symptoms Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013