HIVPhase 3RSSTNCT01327755
Rwanda Selenium Supplementation Clinical Trial
A Phase 3 study testing Selenium in people with HIV, run by The Canadian College of Naturopathic Medicine at 2 sites in Rwanda.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesRwanda
- Study dates
- Feb 2011to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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 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.
Read the 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.
- Conditions
- HIV
- Being tested
- Selenium, Placebo
- Keywords
- Selenium, HIV/ AIDS, CD4 counts, Antiretroviral therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
Selenium yeast containing selenomethionine 200 mcg per day for 2 years
PlaceboOther
Same number of pills, frequency, and duration as selenium intervention.
| Study group | Role | What they receive |
|---|---|---|
| Selenium | Experimental | Not described Receives: Dietary Supplement: Selenium |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD4 count
Measured: Baseline, 6, 12, 18, and 24 months
Secondary outcomes (3)
viral load
Measured: Baseline, 12, and 24 months
Occurrence of opportunistic infections
Measured: Baseline, 6, 12, 18, and 24 months
Incidence of antiretroviral therapy (ART)initiation
Measured: Baseline, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Global Benefit Canada, University of Ottawa, Wilfrid Laurier University, Kibagabaga District Hospital, Kinyinya Health Centre
- Responsible party
- Sponsor
- Investigators
- Julius K Kamwesiga, MD MPH(cand), Principal investigator, Rwanda Selenium Supplementation Clinical TrialDon Warren, BSc ND DHANP, Principal investigator, Global Benefit Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327755
- Sponsor's protocol ID
- RCT-32122010
- Acronym
- RSST
- Status last verified
- Feb 2013
- First submitted
- 11 Jan 2011
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21838913
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01327755
- Acronym / sponsor ID
- RSST / RCT-32122010
- Conditions
- HIV
- Keywords
- Selenium, HIV/ AIDS, CD4 counts, Antiretroviral therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Global Benefit Canada, University of Ottawa, Wilfrid Laurier University, Kibagabaga District Hospital, Kinyinya Health Centre
- Study start
- Feb 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selenium | Experimental | Dietary Supplement: Selenium |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeleniumSelenium yeast containing selenomethionine 200 mcg per day for 2 years | Dietary supplement | Selenium |
| PlaceboSame number of pills, frequency, and duration as selenium intervention. | Other | Placebo |
Primary outcome
CD4 count
Time frame: Baseline, 6, 12, 18, and 24 months
3 secondary outcomes
viral load
Time frame: Baseline, 12, and 24 months
Occurrence of opportunistic infections
Time frame: Baseline, 6, 12, 18, and 24 months
Incidence of antiretroviral therapy (ART)initiation
Time frame: Baseline, 6, 12, 18, and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Derived from this study: PubMed 21838913Kamwesiga 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.
Related trials for HIV
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
RecruitingObservational study
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julius K Kamwesiga, MD MPH(cand) principal investigator
Rwanda Selenium Supplementation Clinical Trial
Don Warren, BSc ND DHANP principal investigator
Global Benefit Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selenium in people with HIV, run by The Canadian College of Naturopathic Medicine at 2 sites in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD4 count (time frame: Baseline, 6, 12, 18, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01327755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013; AzTrials last refreshed its copy on 29 Oct 2026.