Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01425073|
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : April 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Acquired Immunodeficiency Syndrome Disease Progression Immune System Diseases Malaria Parasitic Diseases Pneumonia Diarrhea Infectious Disorder of Immune System||Other: Discontinue TMP/SMZ prophylaxis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Experimental: Stop TMP/SMZ
Arm 1 will have patients discontinue trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis; patients will follow up every 3 months with study staff.
Other: Discontinue TMP/SMZ prophylaxis
Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study
No Intervention: Standard of care TMP/SMZ prophylaxis
Arm 2 will continue standard of care treatment with trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis.
- Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea) [ Time Frame: 12 months ]A combined outcome of malaria, pneumonia or severe diarrhea.
- CD4 count increase [ Time Frame: 12 months ]CD4 count increase
- Rate of ART treatment failure [ Time Frame: 12 months ]Rate of ART treatment failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425073
|Homa Bay District Hospital|
|Homa Bay, Nyanza Pronvince, Kenya|
|Kombewa District Hospital|
|Kombewa, Nyanza, Kenya|
|Principal Investigator:||Christina Polyak, MD, MPH||Kenya Medical Research Institute/ Department of Medicine, University of Washington|