Ignite Creation Date:
2024-05-05 @ 9:16 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00855062
Status:
TERMINATED
Last Update Posted:
2011-02-25
First Post:
2009-03-02
Brief Title:
Minocycline for HIV Cognitive Impairment in Uganda
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda
Status:
TERMINATED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Neurologic AIDS Research Consortium Data Safety and Monitoring Board committee recommended to terminate the study early due to futility on 1162009
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose The purpose of the study is to assess the safety and effectiveness of minocycline an antibiotic in the treatment of Human immunodeficiency virus HIV-associated cognitive impairment in Uganda
Study Design Treatment 24-week Randomized Placebo-Controlled Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 CD4 Count in the 251-350 Range
Arm 1 Minocycline 100 mg orally every 12 hours 50 subjects
Arm 2 Matching placebo orally every 12 hours 50 subjects
Primary Objective
To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline
Secondary Objectives
To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
To examine whether minocycline treatment for 24 weeks improves functional impairment
Study Design Treatment 24-week Randomized Placebo-Controlled Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a cluster of differentiation 4 CD4 Count in the 251-350 Range
Arm 1 Minocycline 100 mg orally every 12 hours 50 subjects
Arm 2 Matching placebo orally every 12 hours 50 subjects
Primary Objective
To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline
Secondary Objectives
To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
To examine whether minocycline treatment for 24 weeks improves functional impairment
Detailed Description:
None
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 |
|---|---|---|---|
| Grant Number 5 UO1 NS32228 | None | None | None |