Rwanda Selenium Supplementation Clinical Trial (RSST)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Dietary Supplement: Selenium Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- CD4 count [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- viral load [ Time Frame: Baseline, 12, and 24 months ] [ Designated as safety issue: No ]
- Occurrence of opportunistic infections [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
- Incidence of antiretroviral therapy (ART)initiation [ Time Frame: Baseline, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2011 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Selenium |
Dietary Supplement: Selenium
Selenium yeast containing selenomethionine 200 mcg per day for 2 years
|
| Placebo Comparator: Placebo |
Other: Placebo
Same number of pills, frequency, and duration as selenium intervention.
|
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| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01327755
| Rwanda | |
| Kibagabaga Hospital | |
| Kigali, Rwanda | |
| Kinyinya Health Center | |
| Kigali, Rwanda | |
| Principal Investigator: | Julius K Kamwesiga, MD MPH(cand) | Rwanda Selenium Supplementation Clinical Trial | |
| Principal Investigator: | Don Warren, BSc ND DHANP | Global Benefit Canada |
More Information
No publications provided by The Canadian College of Naturopathic Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Canadian College of Naturopathic Medicine |
| ClinicalTrials.gov Identifier: | NCT01327755 History of Changes |
| Other Study ID Numbers: | RCT-32122010 |
| Study First Received: | January 11, 2011 |
| Last Updated: | October 28, 2013 |
| Health Authority: | Rwanda: The Rwanda National AIDS Control Commission (CNLS) Rwands: Rwanda Ministry of Health |
Keywords provided by The Canadian College of Naturopathic Medicine:
|
Selenium HIV/ AIDS CD4 counts Antiretroviral therapy |
Additional relevant MeSH terms:
|
Selenium Antioxidants Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Protective Agents Trace Elements |
ClinicalTrials.gov processed this record on March 03, 2015