Trials / Completed
CompletedNCT01425073
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Disease Progression
- Immune System Diseases
- Malaria
- Parasitic Diseases
- Pneumonia
- Diarrhea
- Infectious Disorder of Immune System
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Discontinue TMP/SMZ prophylaxis | Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2011-08-29
- Last updated
- 2014-04-11
Locations
2 sites across 1 country: Kenya
Source: ClinicalTrials.gov record NCT01425073. Inclusion in this directory is not an endorsement.