Rwanda Selenium Supplementation Clinical Trial (RSST)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- CD4 count [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- viral load [ Time Frame: Baseline, 12, and 24 months ] [ Designated as safety issue: No ]
- Occurrence of opportunistic infections [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- Incidence of antiretroviral therapy (ART)initiation [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Dietary Supplement: Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years
|Placebo Comparator: Placebo||
Same number of pills, frequency, and duration as selenium intervention.
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.
|Kinyinya Health Center|
|Principal Investigator:||Julius K Kamwesiga, MD MPH(cand)||Rwanda Selenium Supplementation Clinical Trial|
|Principal Investigator:||Don Warren, BSc ND DHANP||Global Benefit Canada|