Rwanda Selenium Supplementation Clinical Trial

Study Overview
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Brief Summary
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Study Hypothesis: The addition of selenium supplementation to cotrimoxazole will improve CD4 counts, decrease opportunistic infections, decrease viral loads and delay the need for initiating antiretroviral therapy(ART) in Rwandan adult patients infected with HIV/ AIDS.

Detailed Description
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Patients will be recruited from two health facilities (Kibagabaga District Hospital, and Kinyinya Health Center in Kigali), Rwanda that offer care and treatment for HIV/AIDS patients. Patients will be recruited during a 3-4 month period. Consenting adults who fit the inclusion criteria will be enrolled and followed for 2 years. Study assessments will occur at enrollment, 6, 12, 18, and 24 months after initiation of selenium supplementation. 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.

Official Title
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Effect of Selenium Supplementation on CD4 + Cell Recovery, Viral Suppression, Morbidity and Quality of Life of HIV Infected Patients in Rwanda: a Prospective, Double-Blinded, Placebo-Controlled Trial

Conditions
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HIV

Intervention / Treatment
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* Dietary Supplement: Selenium
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients > or = 21 years at enrollment 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 intending to be transferred out of the clinic catchment area before study ends Patients scheduled to start ART Moribund patients Pregnant women Unable or not wanting to commit to barrier method of birth control

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selenium<br> | Dietary Supplement: Selenium<br>* Selenium yeast containing selenomethionine 200 mcg per day for 2 years<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Same number of pills, frequency, and duration as selenium intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 count |  | Baseline, 6, 12, 18, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| viral load |  | Baseline, 12, and 24 months | 
| Occurrence of opportunistic infections |  | Baseline, 6, 12, 18, and 24 months | 
| Incidence of antiretroviral therapy (ART)initiation |  | Baseline, 6, 12, 18, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Selenium, HIV/ AIDS, CD4 counts, Antiretroviral therapy