Phase 4
Completed N=70
Effectiveness of Armodafinil for Treating Fatigue in Adults With HIV/AIDS
Source: ClinicalTrials.gov NCT00737204 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Fatigue Severity Scale(FSS) Outcome — 52.6; 53.1; 25.8; 39.4 units on a scale — p=<0.001
Summary
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Severity Scale(FSS) Outcome |
52.6; 53.1; 25.8; 39.4 | <0.001 sig |
| PRIMARY Role Function Scale |
36.2; 37.8; 19.9; 28.3 | .01 sig |
| SECONDARY CD4 Cell Count |
502; 450; 503; 445 | >=.805 |
| SECONDARY HIV Viral Load |
2.17; 2.39; 2.15; 2.24 | — |
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT00737204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.