NCT01327755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3 hiv

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2011

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

October 29, 2013

Status Verified

February 1, 2013

Enrollment Period

2.5 years

First QC Date

January 11, 2011

Last Update Submit

October 28, 2013

Conditions

HIV

Keywords

SeleniumHIV/ AIDSCD4 countsAntiretroviral therapy

Outcome Measures

Primary Outcomes (1)

  • CD4 count

    Baseline, 6, 12, 18, and 24 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Selenium

EXPERIMENTAL
Dietary Supplement: Selenium

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

SeleniumDIETARY_SUPPLEMENT

Selenium yeast containing selenomethionine 200 mcg per day for 2 years

Selenium
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kibagabaga Hospital

Kigali, Rwanda

Location

Kinyinya Health Center

Kigali, Rwanda

Location

Related Publications (1)

  • 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.

    PMID: 21838913DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Selenium

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMinerals

Study Officials

  • Julius K Kamwesiga, MD MPH(cand)

    Rwanda Selenium Supplementation Clinical Trial

    PRINCIPAL INVESTIGATOR

  • Don Warren, BSc ND DHANP

    Global Benefit Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

April 4, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 29, 2013

Record last verified: 2013-02

Locations

RW(2)