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

University of Washington

Status: Completed

Conditions: Diarrhea; Parasitic Diseases; Disease Progression; Infectious Disorder of Immune System; Immune System Diseases; Malaria; Pneumonia; HIV Infections; Acquired Immunodeficiency Syndrome

Treatments: Other: Discontinue TMP/SMZ prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT01425073

40461-B

Details and patient eligibility

About

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.

Full description

Please see summary above.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Stop TMP/SMZ

Experimental group

Description:

Arm 1 will have patients discontinue trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis; patients will follow up every 3 months with study staff.

Treatment:

Other: Discontinue TMP/SMZ prophylaxis

Standard of care TMP/SMZ prophylaxis

No Intervention group

Description:

Arm 2 will continue standard of care treatment with trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis.