An interventional study of Discontinue TMP/SMZ prophylaxis in HIV Infections, Acquired Immunodeficiency Syndrome and Disease Progression, sponsored by University of Washington. Completed at 2 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-11.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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Exclusion Criteria:
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
Arm 2 will continue standard of care treatment with trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis.
Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study
Also known as: Septrin, Septra, Cotrimoxazole, Bactrim
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
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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