Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya

This study has been completed.
Kenya Medical Research Institute
Information provided by (Responsible Party):
Christina Polyak, University of Washington
ClinicalTrials.gov Identifier:
First received: August 25, 2011
Last updated: April 9, 2014
Last verified: April 2014
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.

Condition Intervention
HIV Infections
Acquired Immunodeficiency Syndrome
Disease Progression
Immune System Diseases
Parasitic Diseases
Infectious Disorder of Immune System
Other: Discontinue TMP/SMZ prophylaxis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A combined outcome of malaria, pneumonia or severe diarrhea.

Secondary Outcome Measures:
  • CD4 count increase [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CD4 count increase

  • Rate of ART treatment failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Rate of ART treatment failure

Enrollment: 500
Study Start Date: February 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • Septrin
  • Septra
  • Cotrimoxazole
  • Bactrim
No Intervention: Standard of care TMP/SMZ prophylaxis
Arm 2 will continue standard of care treatment with trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis.

Detailed Description:
Please see summary above.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01425073

Homa Bay District Hospital
Homa Bay, Nyanza Pronvince, Kenya
Kombewa District Hospital
Kombewa, Nyanza, Kenya
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
Principal Investigator: Christina Polyak, MD, MPH Kenya Medical Research Institute/ Department of Medicine, University of Washington
  More Information


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christina Polyak, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01425073     History of Changes
Other Study ID Numbers: 40461-B 
Study First Received: August 25, 2011
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board

Keywords provided by University of Washington:

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
Disease Progression
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Parasitic Diseases
Disease Attributes
Lentivirus Infections
Lung Diseases
Pathologic Processes
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antiparasitic Agents
Antiprotozoal Agents

ClinicalTrials.gov processed this record on May 26, 2016