Rwanda Selenium Supplementation Clinical Trial

HIV Clinical Trial

— RSST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327755
• Other study ID #: RCT-32122010
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2011
• Last updated: October 28, 2013
• Start date: February 2011
• Est. completion date: August 2013

Study information

• Verified date: February 2013
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Rwanda: The Rwanda National AIDS Control Commission (CNLS)Rwands: Rwanda Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Dietary Supplement:
• Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years

Other:
• Placebo
Same number of pills, frequency, and duration as selenium intervention.

Locations

Country	Name	City	State
Rwanda	Kibagabaga Hospital	Kigali
Rwanda	Kinyinya Health Center	Kigali

Sponsors (6)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	Global Benefit Canada, Kibagabaga District Hospital, Kinyinya Health Centre, University of Ottawa, Wilfrid Laurier University

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 count		Baseline, 6, 12, 18, and 24 months	No
Secondary	viral load		Baseline, 12, and 24 months	No
Secondary	Occurrence of opportunistic infections		Baseline, 6, 12, 18, and 24 months	No
Secondary	Incidence of antiretroviral therapy (ART)initiation		Baseline, 6, 12, 18, and 24 months	No