Phase 4
Completed N=115
Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS
Source: ClinicalTrials.gov NCT00118378 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Fatigue Severity Scale (FSS) — 52; 52; 34; 43 units on a scale — p=< 0.001
Summary
This study will determine whether modafinil (Provigil®), a medication approved for the treatment of narcolepsy, is effective in reducing fatigue in adults with HIV/AIDS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Severity Scale (FSS) |
52; 52; 34; 43 | < 0.001 sig |
| PRIMARY Role Function Scale Outcome |
39; 36; 22; 27 | <0.001 sig |
| SECONDARY CD4 Cell Count |
481; 459; 466; 482 | .150 |
| SECONDARY HIV RNA Viral Load |
2.53; 2.41; 2.31; 2.30 | .459 |
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 [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 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
Data sourced from ClinicalTrials.gov (NCT00118378). 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.