Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
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| ClinicalTrials.gov Identifier: NCT00118378 |
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Recruitment Status
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Completed
First Posted
: July 11, 2005
Results First Posted
: June 9, 2014
Last Update Posted
: May 10, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Fatigue | Drug: Modafinil Drug: Placebo | Phase 4 |
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. This study will determine if modafinil can reduce fatigue in HIV/AIDS patients.
This study will last 12 weeks. Participants will be randomly assigned to receive either modafinil or placebo daily for 4 weeks. Participants who show an improvement in symptoms will receive modafinil for an additional 8 weeks. Participants who do not respond to modafinil will have the opportunity to receive other drug treatments. 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 115 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Modafinil Treatment for Fatigue in HIV+ Patients |
| Study Start Date : | December 2004 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | November 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Modafinil
Participants will take modafinil for 4 weeks.
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Drug: Modafinil
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: Provigil
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Placebo Comparator: Placebo
Participants will take placebo for 4 weeks.
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Drug: Placebo
50 mg per day, increasing to 200 mg per day as clinically indicated
Other Name: sugar pill
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- Fatigue Severity Scale (FSS) [ Time Frame: Measured at baseline and Week 4 ]The FSS is a 9-item self-report scale that measures the impact of fatigue on everyday functioning. Each item is rated on a scale of 1 to 7. Total scores range from 9 to 63, with a higher value indicating greater impairment due to fatigue.
- Role Function Scale Outcome [ Time Frame: Measured at baseline and Week 4 ]The Role Function Scale includes 10 items drawn from the Short Form 36-item Health Survey (SF-36) and other SF versions. It is intended to assess the extent to which fatigue has a behavioral impact on daily activities. Scores of frequency in the past week, on a 5-point scale, are summed with higher scores signifying greater role impairment. Scores range from 10 to 50.
- CD4 Cell Count [ Time Frame: Measured at baseline and Week 4 ]CD4 cell count is a laboratory marker providing an indication of immune functioning. Blood was drawn for this measure at baseline and week 4. The reference range for CD4 cell count is 490-1740, and a clinically significant change is defined as a change of >= 100 cells. A higher number is associated with better immune functioning.
- HIV RNA Viral Load [ Time Frame: Measured at baseline and Week 4 ]HIV RNA viral load assay is a laboratory measure indicating viral activity. Because of the large range of possible values (50-100,000 copies), this measure is presented in log10. We entered the log10 value of 1.69 when the laboratory result stated "under 50 copies," which was the assay's lowest limit of detectability during the study.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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)
- 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 [O.I.] 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 [TSH] 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 Rating Scale (HAM-D) >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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118378
| 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 |
Additional Information:
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 ( U.S. NIH Grant/Contract ) DAHBR 9A-ASNM |
| First Posted: | July 11, 2005 Key Record Dates |
| Results First Posted: | June 9, 2014 |
| Last Update Posted: | May 10, 2017 |
| Last Verified: | March 2017 |
Keywords provided by New York State Psychiatric Institute:
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HIV AIDS Modafinil Depression |
Additional relevant MeSH terms:
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HIV Infections Fatigue Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Signs and Symptoms Modafinil Armodafinil Wakefulness-Promoting Agents Central Nervous System Stimulants Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |