Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2011-02-28
2013-08-31
Brief Summary
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Detailed Description
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Participants will be randomized using a simple randomized block design to receive either cotrimoxazole and selenium or cotrimoxazole and an identically appearing placebo taken once daily for 2 years. Participants who do not return to the clinic as scheduled will be followed up at home.
All consenting patients with CD4 count between 400 and 650 mm3 will be selected because they are at similar immunological level and hence they will not be eligible to start ARV treatment at the study start. The study will look at the efficacy of selenium supplementation to this already compromised group of patients at a similar stage of the disease.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Selenium
Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years
Placebo
Placebo
Same number of pills, frequency, and duration as selenium intervention.
Interventions
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Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years
Placebo
Same number of pills, frequency, and duration as selenium intervention.
Eligibility Criteria
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Inclusion Criteria
* Confirmed HIV positive with a CD4 range between 400 and 650 mm3
* HIV+ patients willing to participate in the study and who provide informed consent
* Pre-antiretroviral therapy (Pre-ART) at enrollment in study (not yet initiated ART)
* Willing to practice barrier method of birth control at all times
Exclusion Criteria
* Patients scheduled to start ART
* Moribund patients
* Pregnant women
* Unable or not wanting to commit to barrier method of birth control
21 Years
ALL
No
Sponsors
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Global Benefit Canada
UNKNOWN
University of Ottawa
OTHER
Wilfrid Laurier University
OTHER
Kibagabaga District Hospital
UNKNOWN
Kinyinya Health Centre
UNKNOWN
The Canadian College of Naturopathic Medicine
OTHER
Responsible Party
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Principal Investigators
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Julius K Kamwesiga, MD MPH(cand)
Role: PRINCIPAL_INVESTIGATOR
Rwanda Selenium Supplementation Clinical Trial
Don Warren, BSc ND DHANP
Role: PRINCIPAL_INVESTIGATOR
Global Benefit Canada
Locations
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Kibagabaga Hospital
Kigali, , Rwanda
Kinyinya Health Center
Kigali, , Rwanda
Countries
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References
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Kamwesiga J, Mutabazi V, Kayumba J, Tayari JC, Smyth R, Fay H, Umurerwa A, Baziruwiha M, Ntizimira C, Murebwayire A, Haguma JP, Nyiransabimana J, Habarurema D, Mukarukundo V, Nzabandora JB, Nzamwita P, Mukazayire E, Mills EJ, Seely D, McCready DJ, Warren D. Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial. Trials. 2011 Aug 13;12:192. doi: 10.1186/1745-6215-12-192.
Other Identifiers
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RCT-32122010
Identifier Type: -
Identifier Source: org_study_id