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Rwanda Selenium Supplementation Clinical Trial (RSST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01327755
Recruitment Status : Completed
First Posted : April 4, 2011
Last Update Posted : October 29, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV Dietary Supplement: Selenium Other: Placebo Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. CD4 count [ Time Frame: Baseline, 6, 12, 18, and 24 months ]

Secondary Outcome Measures :
  1. viral load [ Time Frame: Baseline, 12, and 24 months ]
  2. Occurrence of opportunistic infections [ Time Frame: Baseline, 6, 12, 18, and 24 months ]
  3. Incidence of antiretroviral therapy (ART)initiation [ Time Frame: Baseline, 6, 12, 18, and 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327755


Locations
Rwanda
Kibagabaga Hospital
Kigali, Rwanda
Kinyinya Health Center
Kigali, Rwanda
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Global Benefit Canada
University of Ottawa
Wilfrid Laurier University
Kibagabaga District Hospital
Kinyinya Health Centre
Investigators
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

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
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: February 2013

Keywords provided by The Canadian College of Naturopathic Medicine:
Selenium
HIV/ AIDS
CD4 counts
Antiretroviral therapy

Additional relevant MeSH terms:
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances