Rwanda Selenium Supplementation Clinical Trial

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01327755

Acronym

RSST

Enrollment

300

Registered

2011-04-04

Start date

2011-02-28

Completion date

2013-08-31

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Selenium, HIV/ AIDS, CD4 counts, Antiretroviral therapy

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.

Interventions

DIETARY_SUPPLEMENTSelenium

Selenium yeast containing selenomethionine 200 mcg per day for 2 years

OTHERPlacebo

Same number of pills, frequency, and duration as selenium intervention.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CD4 count	Baseline, 6, 12, 18, and 24 months

Secondary

Measure	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

Countries

Rwanda

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026