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Sponsors and Collaborators: |
University of Washington Kenya Medical Research Institute |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00914225 |
In many areas of the world most severely affected by the HIV/AIDS pandemic, insect and water-borne diseases such as malaria and diarrheal disease are common causes of illness and death. In addition, diarrhea and malaria are more common and more severe among adults and children infected with HIV. These infections may modulate the immune system, affect the replication of the HIV virus and could result in more rapid HIV disease progression in co-infected individuals. Access to practical, inexpensive and easy to use interventions to prevent these diseases may be effective in delaying HIV progression.
Current Kenya government and World Health Organization guidelines recommend the use of cotrimoxazole (trimethoprim-sulfamethoxazole [TMP/SMX]) to prevent co-infections, including malaria. Despite the provision of TMP/SMX to HIV-infected adults, infections with malaria and pathogens causing diarrhea remain common causes of morbidity and mortality in many resource-limited settings. In addition, TMP/SMX may not prevent all infections with malaria or other pathogens due to alternative mechanisms of action, antimicrobial resistance and non-compliance due to adverse events or other reasons.
We propose a study to evaluate the impact of providing insecticide treated bednets and a simple water filtration device on markers of HIV disease progression among a cohort of ART naïve, HIV infected adults prescribed TMP/SMX in Kenya. In addition, we propose to evaluate the effect of these interventions on malaria and diarrheal disease incidence and on compliance with TMP/SMX.
Condition | Intervention |
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HIV Infections Human Immunodeficiency Virus Malaria Plasmodium Falciparum Diarrhea |
Other: Bednets and Water Purification |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Effect of Long-Lasting Insecticide-Treated Bednets and a Point-of-Use Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya |
Plasma HIV RNA Plasma for Malaria PCR
Estimated Enrollment: | 500 |
Study Start Date: | July 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1 |
Other: Bednets and Water Purification
Randomized controlled trial comparing HIV disease progression in those subjects receiving standard of care versus empiric deworming. Subjects are followed for 24 months and have serial measurements of HIV disease progression, and are evaluated serially for evidence of malaria, diarrhea and other co-morbidities. Data collected on the frequency of malaria and diarrheal disease, their use of LLIN and water filtration and their compliance with TMP/SMX.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The study will compare markers of HIV disease progression among ART naive individuals receiving LLIN and a simple microbiological water purification system to historical comparison group from the same clinic settings.
We are enrolling 850 HIV infected ART naïve individuals into a randomized controlled trial comparing HIV disease progression in those receiving standard of care versus empiric deworming. Subjects are followed for 24 months and have serial measurements of HIV disease progression, and are evaluated serially for evidence of malaria, diarrhea and other co-morbidities. Participants in this study will have been consented for the collection of data on the frequency of malaria and diarrheal disease, their use of LLIN and water filtration and their compliance with TMP/SMX.
Inclusion Criteria:
Participants must not be or have ever been on highly active antiretroviral therapy CD4 count at enrollment of
Exclusion Criteria:
Contact: Ben Piper, MEM MPH | +254729048847 | benpiper@u.washington.edu |
Contact: Benson Singa, MBChB MPH | +254725234844 | singabo2008@gmail.com |
Kenya | |
Kisumu District Hospital, UW/KEMRI Research Clinic | |
Kisumu, Kenya | |
Kisii Provincial Hospital | |
Kisii, Kenya |
Principal Investigator: | Judd T Walson, MD MPH | University of Washington |
Principal Investigator: | Benson Singa, MBChB MPH | Kenya Medical Research Institute |
Responsible Party: | University of Washington ( Judd Walson MD MPH ) |
Study ID Numbers: | 35464-B |
Study First Received: | June 2, 2009 |
Last Updated: | July 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00914225 History of Changes |
Health Authority: | United States: Institutional Review Board; Kenya: Institutional Review Board |
Human immunodeficiency virus malaria plasmodium falciparum diarrhea |
helminth HIV Treatment naive |
Protozoan Infections Sexually Transmitted Diseases, Viral Diarrhea Signs and Symptoms, Digestive Acquired Immunodeficiency Syndrome Disease Progression Malaria Immunologic Deficiency Syndromes |
Virus Diseases Signs and Symptoms HIV Infections Sexually Transmitted Diseases Parasitic Diseases Helminthiasis Retroviridae Infections |
Protozoan Infections Disease Attributes RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Diarrhea Signs and Symptoms, Digestive Immune System Diseases Coccidiosis Acquired Immunodeficiency Syndrome Disease Progression |
Malaria Infection Immunologic Deficiency Syndromes Virus Diseases Signs and Symptoms Pathologic Processes HIV Infections Sexually Transmitted Diseases Lentivirus Infections Parasitic Diseases Retroviridae Infections |