Clinical trial NCT01327755: Rwanda Selenium Supplementation Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Keywords: Selenium
HIV/ AIDS
CD4 counts
Antiretroviral therapy
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Global Benefit Canada
name: University of Ottawa
name: Wilfrid Laurier University
name: Kibagabaga District Hospital
name: Kinyinya Health Centre
First posted: 2011-04-04
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: CD4 count
timeFrame: Baseline, 6, 12, 18, and 24 months
Secondary outcomes:
measure: viral load
timeFrame: Baseline, 12, and 24 months
measure: Occurrence of opportunistic infections
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Incidence of antiretroviral therapy (ART)initiation
timeFrame: Baseline, 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Kibagabaga Hospital
city: Kigali
country: Rwanda
facility: Kinyinya Health Center
Study officials:
affiliation: Rwanda Selenium Supplementation Clinical Trial
name: Julius K Kamwesiga, MD MPH(cand)
role: PRINCIPAL_INVESTIGATOR
affiliation: Global Benefit Canada
name: Don Warren, BSc ND DHANP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.