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

Not Applicable

Completed

• Conditions: Immune System Diseases; HIV Infections; Parasitic Diseases; Diarrhea; Infectious Disorder of Immune System; Acquired Immunodeficiency Syndrome; Malaria; Disease Progression; Pneumonia
• Interventions: Other: Discontinue TMP/SMZ prophylaxis

• Registration Number: NCT01425073
• Lead Sponsor: 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.

Detailed Description

Please see summary above.

Study Timeline

• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Study Start: 2012-02
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea)	12 months	A combined outcome of malaria, pneumonia or severe diarrhea.

Secondary Outcome Measures

Name	Time	Method
CD4 count increase	12 months	CD4 count increase
Rate of ART treatment failure	12 months	Rate of ART treatment failure

Trial Locations

Locations (2)

Homa Bay District Hospital; 🇰🇪 Homa Bay, Nyanza Pronvince, Kenya

Kombewa District Hospital; 🇰🇪 Kombewa, Nyanza, Kenya