Ignite Creation Date:
2024-05-05 @ 11:50 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01425073
Status:
COMPLETED
Last Update Posted:
2014-04-11
First Post:
2011-08-25
Brief Title:
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2014-04
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:
Both antiretroviral therapy ART and prevention of opportunistic infections OIs have been associated with significantly decreased mortality in HIV-infected individuals Trimethoprim-sulfamethoxazole TMPSMZ also known as bactrim is a common antibiotic and used as prophylaxis for OIs For countries with high prevalence of HIV and limited health infrastructure the WHO endorses universal TMPSMZ for all HIV-infected individuals Notably these guidelines were created prior to the scale-up of ARTs Following ART and subsequent immune recovery TMPSMZ may no longer be required In the US and Europe for example TMPSMZ is discontinued after patients show evidence of immune recovery Therefore we propose a prospective randomized trial among HIV infected individuals on ART with evidence of immune recovery ART for 18mo and CD4 350 cellsmm3 to determine whether continued TMPSMZ prophylaxis confers benefits in decreasing morbidity malaria pneumonia diarrhea mortality CD4 count maintenance ART treatment failure and malaria immune responses
Detailed Description:
Please see summary above
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