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

Condition(s) targeted: HIV Infections; Acquired Immunodeficiency Syndrome; Disease Progression; Immune System Diseases; Malaria; Parasitic Diseases; Pneumonia; Diarrhea; Infectious Disorder of Immune System

Intervention: Discontinue TMP/SMZ prophylaxis (Other)

Phase: N/A

Status: Completed

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Christina Polyak, MD, MPH, Principal Investigator, Affiliation: Kenya Medical Research Institute/ Department of Medicine, University of Washington

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.

Official title: Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea)

Secondary outcome:

CD4 count increase

Rate of ART treatment failure

Detailed description: Please see summary above.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Kombewa District Hospital, Kombewa, Nyanza, Kenya

Homa Bay District Hospital, Homa Bay, Nyanza Pronvince, Kenya

Related publications:

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Starting date: February 2012
Last updated: April 9, 2014