At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 70 enrolled
Drug / intervention
Armodafinil +1 moredrug
Likely dose
Armodafinil 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Armodafinil Treatment for Fatigue in HIV+ Patients
In Brief
A Phase 4 clinical trial evaluating Armodafinil and Placebo for HIV Infections and Fatigue. Completed, enrolled 70 participants across 1 site.
Detailed Summary
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, 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
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedAug 2008
Primary CompletionApr 2010
Study CompletionSep 2010
TodayJul 2026
First PostedAug 18, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.9 years ago
Interventions
Armodafinildrug
Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated.
Placebodrug
Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy