Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118378
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2005-07-06
Brief Title:
Effectiveness of Modafinil for Treating Fatigue in Adults With HIVAIDS
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Modafinil Treatment for Fatigue in HIV Patients
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether modafinil Provigil a medication approved for the treatment of narcolepsy is effective in reducing fatigue in adults with HIVAIDS
Detailed Description:
Fatigue is a common problem for many people with HIVAIDS 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 HIVAIDS 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAHBR 9A-ASNM | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH072383-01 |
| R01MH072383-01 | NIH | None | None |