At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 115 enrolled
Drug / intervention
Modafinil +1 moredrug
Likely dose
Modafinil 50 mg per day, increasing to 200 mg per day as clinically indicatedAI-extracted
Key inclusion· 6
- ✓Age 18–75 years
- ✓HIV-positive
- ✓Clinically significant fatigue (Fatigue Severity Scale ≥4.5 plus impairment in ≥1 Role Function Scale category)
- ✓Fatigue duration ≥3 months
Key exclusion· 17
- ✕Unstable medical condition (e.g., liver failure, cirrhosis, new-onset opportunistic infection in past month)
- ✕Untreated hypogonadism (except men medically contraindicated for testosterone replacement)
- ✕Untreated hypothyroidism (TSH >5 IUI/mL)
- ✕Untreated and uncontrolled hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Modafinil Treatment for Fatigue in HIV+ Patients
In Brief
A Phase 4 clinical trial evaluating Modafinil and Placebo for HIV Infections and Fatigue. Completed, enrolled 115 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, Fatigue
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedJul 2005
Primary CompletionJun 2010
Study CompletionNov 2010
TodayJul 2026
First PostedJul 11, 2005
Enrollment StartDec 1, 2004
Primary CompletionJun 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 21.0 years ago
Interventions
Modafinildrug
50 mg per day, increasing to 200 mg per day as clinically indicated
Placebodrug
50 mg per day, increasing to 200 mg per day as clinically indicated