Trial record 3 of 39 for:
" August 17, 2011":" September 16, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Discontinuation of Trimethoprim-sulfamethoxazole Prophylaxis in Adults on Antiretroviral Therapy in Kenya
This study is currently recruiting participants.
Verified May 2012 by University of Washington
Sponsor:
University of Washington
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: May 22, 2012
Last verified: May 2012
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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
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 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:
|
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425073
Contacts
| Contact: Benson Singa, MBChB, MPH | 0725 234 844 | singabo2008@gmail.com |
Locations
| Kenya | |
| Homa Bay District Hospital | Recruiting |
| Homa Bay, Nyanza Pronvince, Kenya | |
| Contact: Christina Polyak, MD MPH +254701648519 cpolyak@uw.edu | |
| Kombewa District Hospital | Not yet recruiting |
| 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: | May 22, 2012 |
| 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 June 17, 2013