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. Identifier: NCT01425073
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : April 11, 2014
Kenya Medical Research Institute
Information provided by (Responsible Party):
Christina Polyak, University of Washington

August 25, 2011
August 29, 2011
April 11, 2014
February 2012
October 2013   (Final data collection date for primary outcome measure)
Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea) [ Time Frame: 12 months ]
A combined outcome of malaria, pneumonia or severe diarrhea.
Same as current
Complete list of historical versions of study NCT01425073 on Archive Site
  • CD4 count increase [ Time Frame: 12 months ]
    CD4 count increase
  • Rate of ART treatment failure [ Time Frame: 12 months ]
    Rate of ART treatment failure
Same as current
Not Provided
Not Provided
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial
Both antiretroviral therapy (ART) and prevention of opportunistic infections (OIs) have been associated with significantly decreased mortality in HIV-infected individuals. Trimethoprim-sulfamethoxazole (TMP/SMZ), 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 TMP/SMZ for all HIV-infected individuals. Notably, these guidelines were created prior to the scale-up of ARTs. Following ART and subsequent immune recovery, TMP/SMZ may no longer be required. In the US and Europe, for example, TMP/SMZ 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 cells/mm3) to determine whether continued TMP/SMZ prophylaxis confers benefits in decreasing morbidity (malaria, pneumonia, diarrhea), mortality, CD4 count maintenance, ART treatment failure and malaria immune responses.
Please see summary above.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study
Other Names:
  • Septrin
  • Septra
  • Cotrimoxazole
  • Bactrim
  • 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.
    Intervention: Other: Discontinue TMP/SMZ prophylaxis
  • No Intervention: Standard of care TMP/SMZ prophylaxis
    Arm 2 will continue standard of care treatment with trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2013
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants must be at least 18 years of age.
  • Participants must be willing to participate and give written informed consent.
  • Participants must be willing and able to return for the scheduled follow-up visits.
  • Participants must have been on ART for > 18 months.
  • Participants must have a CD4 count of > 350 cells/mm3.
  • Participants must not be suspected of ART treatment failure.

Exclusion Criteria:

  • Participants must not be pregnant at enrollment (by urine HCG testing).
  • Participants must not be breastfeeding at the time of enrollment.
  • Participants must be on first-line ART therapy as defined by Kenyan National Guidelines.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Christina Polyak, University of Washington
University of Washington
Kenya Medical Research Institute
Principal Investigator: Christina Polyak, MD, MPH Kenya Medical Research Institute/ Department of Medicine, University of Washington
University of Washington
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP