Clinical trial NCT01425073: Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya
Official title: Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Disease Progression
Immune System Diseases
Malaria
Parasitic Diseases
Pneumonia
Diarrhea
Infectious Disorder of Immune System
Keywords: HIV
Co-Infections
Malaria
Pneumonia
Diarrhea
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
First posted: 2011-08-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea)
timeFrame: 12 months
Secondary outcomes:
measure: CD4 count increase
timeFrame: 12 months
measure: Rate of ART treatment failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Homa Bay District Hospital
state: Nyanza Pronvince
city: Kombewa
country: Kenya
facility: Kombewa District Hospital
state: Nyanza
Study officials:
affiliation: Kenya Medical Research Institute/ Department of Medicine, University of Washington
name: Christina Polyak, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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