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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

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 (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 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

Detailed Description:
Please see summary above.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea) [ Time Frame: 12 months ]
    A combined outcome of malaria, pneumonia or severe diarrhea.

Secondary Outcome Measures :
  1. CD4 count increase [ Time Frame: 12 months ]
    CD4 count increase

  2. Rate of ART treatment failure [ Time Frame: 12 months ]
    Rate of ART treatment failure

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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 identifier (NCT number): 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


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christina Polyak, Principal Investigator, University of Washington Identifier: NCT01425073     History of Changes
Other Study ID Numbers: 40461-B
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014

Keywords provided by Christina Polyak, University of Washington:

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Disease Progression
Immune System Diseases
Communicable Diseases
Parasitic Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Protozoan Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Slow Virus Diseases
Disease Attributes
Pathologic Processes
Anti-Retroviral Agents
Trimethoprim, Sulfamethoxazole Drug Combination