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| Name | Class |
|---|---|
| Global Benefit Canada | UNKNOWN |
| University of Ottawa | OTHER |
| Wilfrid Laurier University | OTHER |
| Kibagabaga District Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium | Dietary Supplement | Selenium yeast containing selenomethionine 200 mcg per day for 2 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| CD4 count | Baseline, 6, 12, 18, and 24 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julius K Kamwesiga, MD MPH(cand) | Rwanda Selenium Supplementation Clinical Trial | Principal Investigator |
| Don Warren, BSc ND DHANP | Global Benefit Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kibagabaga Hospital | Kigali | Rwanda | ||||
| Kinyinya Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21838913 | Derived | 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. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
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| UNKNOWN |
| Kinyinya Health Centre | UNKNOWN |
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| Placebo | Other | Same number of pills, frequency, and duration as selenium intervention. |
|
| Baseline, 6, 12, 18, and 24 months |
| Kigali |
| Rwanda |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |