Trial record 2 of 34 for:    " August 10, 2011":" September 09, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study has been completed.
Sponsor:
Collaborator:
Kenya Medical Research Institute
Information provided by (Responsible Party):
Christina Polyak, University of Washington
ClinicalTrials.gov Identifier:
NCT01425073
First received: August 25, 2011
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya: a Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Incidence of severe infectious morbidity (malaria, pneumonia, diarrhea) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A combined outcome of malaria, pneumonia or severe diarrhea.


Secondary Outcome Measures:
  • CD4 count increase [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CD4 count increase

  • Rate of ART treatment failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Rate of ART treatment failure


Enrollment: 500
Study Start Date: February 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stop TMP/SMZ
Arm 1 will have patients discontinue trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis; patients will follow up every 3 months with study staff.
Other: Discontinue TMP/SMZ prophylaxis
Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study
Other Names:
  • Septrin
  • Septra
  • Cotrimoxazole
  • Bactrim
No Intervention: Standard of care TMP/SMZ prophylaxis
Arm 2 will continue standard of care treatment with trimethoprim-sulfamethoxazole (TMP/SMZ) prophylaxis.

Detailed Description:

Please see summary above.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425073

Locations
Kenya
Homa Bay District Hospital
Homa Bay, Nyanza Pronvince, Kenya
Kombewa District Hospital
Kombewa, Nyanza, Kenya
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
Investigators
Principal Investigator: Christina Polyak, MD, MPH Kenya Medical Research Institute/ Department of Medicine, University of Washington
  More Information

Publications:

Responsible Party: Christina Polyak, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01425073     History of Changes
Other Study ID Numbers: 40461-B
Study First Received: August 25, 2011
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board

Keywords provided by University of Washington:
HIV
Co-Infections
Malaria
Pneumonia
Diarrhea

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Communicable Diseases
Infection
Diarrhea
Immunologic Deficiency Syndromes
Immune System Diseases
Malaria
Parasitic Diseases
Pneumonia
Disease Progression
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Protozoan Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 11, 2014