Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013585
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-03-22
Brief Title:
Safety and Effectiveness of the Selegiline Patch for Decreased Mental Function in HIV Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Placebo-Controlled Double-Blind Study of the Selegiline Transdermal System STS in the Treatment of HIV-Associated Cognitive Impairment
Status:
COMPLETED
Status Verified Date:
2021-10
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:
A decrease in mental function often occurs in patients with HIV Antiretroviral ARV drugs are used to treat this but are not entirely effective Some other therapy could play a role The drug selegiline in its pill form is used to treat Parkinsons disease a serious brain disorder It is believed this drug might protect the brain and repair some damage This study will use this drug in a patch form which has not been approved by the Food and Drug Administration FDA to see if it helps with decreased mental function in patients with HIV The purpose of this study is to evaluate the use of selegiline transdermal system STS in the treatment of decreased mental function in patients with HIV
Detailed Description:
Cognitive impairment is a common adverse effect of HIV infection that can progress to dementia ARVs are the only current therapy but treatment response is frequently unsatisfactory short lived or the agents are poorly tolerated in doses adequate for central nervous system CNS penetration An adjunctive therapy that interferes with the cascade of events triggered by the virus is likely to play an important role Oral selegiline is an approved and marketed drug for the symptomatic treatment of Parkinsons disease Studies suggest that selegiline has a neuroprotective effect and that it may exert a rescue effect on dying and injured neurons This study proposes to use transdermal selegiline which may deliver a greater dose level than oral administration in the treatment of HIV-associated cognitive impairment
This is a two-step study with each step lasting 24 weeks Step 1 is double-blind and Step 2 is open label At entry patients are randomly assigned to receive either the STS or placebo One STS patch will be applied daily at the same time for 24 weeks Patients are evaluated at the clinic at entry and at Weeks 2 4 8 12 16 and 24 Cognitive status will be evaluated by performance on a series of neuropsychological assessments Patients who complete Step 1 may participate in Step 2 Patients on placebo in Step 1 will receive active STS treatment in Step 2 The STS patch is applied once daily for an additional 24 weeks and patients are evaluated at the clinic at Weeks 28 36 and 48
This is a two-step study with each step lasting 24 weeks Step 1 is double-blind and Step 2 is open label At entry patients are randomly assigned to receive either the STS or placebo One STS patch will be applied daily at the same time for 24 weeks Patients are evaluated at the clinic at entry and at Weeks 2 4 8 12 16 and 24 Cognitive status will be evaluated by performance on a series of neuropsychological assessments Patients who complete Step 1 may participate in Step 2 Patients on placebo in Step 1 will receive active STS treatment in Step 2 The STS patch is applied once daily for an additional 24 weeks and patients are evaluated at the clinic at Weeks 28 36 and 48
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 |
|---|---|---|---|
| AACTG A5090 | Registry Identifier | DAIDS ES | None |
| 10075 | REGISTRY | None | None |
| ACTG A5090 | None | None | None |