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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study
Homa Bay District Hospital
Homa Bay, Nyanza Pronvince, Kenya
Kombewa District Hospital
Kombewa, Nyanza, Kenya
Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea)
A combined outcome of malaria, pneumonia or severe diarrhea.
Time frame: 12 months
CD4 count increase
CD4 count increase
Time frame: 12 months
Rate of ART treatment failure
Rate of ART treatment failure
Time frame: 12 months
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