Skip to main content
OpenTrials
Completed

NCT Number: NCT01425073

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Coinfection Communicable Diseases Diarrhea Disease Attributes Disease Progression Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Infectious Disorder of Immune System Lentivirus Infections Lung Diseases Malaria Mosquito-Borne Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Protozoan Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Signs and Symptoms, Digestive Slow Virus Diseases Urogenital Diseases Vector Borne Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kombewa District Hospital, Kombewa, Nyanza, Kenya

Loading trial locations.

About this study

Please see summary above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Discontinue TMP/SMZ prophylaxis

Other

Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study

Other names: Septrin, Septra, Cotrimoxazole, Bactrim

Primary outcomes

  1. Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea)

    Time frame: 12 months

    A combined outcome of malaria, pneumonia or severe diarrhea.

Secondary outcomes

  1. CD4 count increase

    Time frame: 12 months

    CD4 count increase

  2. Rate of ART treatment failure

    Time frame: 12 months

    Rate of ART treatment failure

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kenya Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2011
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.