Status:
COMPLETED
Micronutrients and Antioxidants in HIV Infection
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
CIHR Canadian HIV Trials Network
Ontario HIV Treatment Network
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has i...
Detailed Description
Background: Antiretroviral therapy (ART) has improved the prognosis of persons with human immunodeficiency virus (HIV) infection, but is expensive and potentially toxic. Micronutrient deficiencies occ...
Eligibility Criteria
Inclusion
- be an asymptomatic HIV infected adult
- at least 18 years of age
- have CD4+ cells between 375 and 750 cells/mm3
- have received no ART (excluding less than seven days and perinatal transmission prophylaxis)
- if a woman of child bearing potential, have a negative pregnancy test within two weeks prior to randomization and agree to practice barrier method of birth control during the study
- be willing and able to sign informed consent and to comply with the study protocol
Exclusion
- have HIV-2 infection alone
- have known allergy or intolerance to any study medication ingredient
- be pregnant
- have active treatment for an acute opportunistic infection or malignancy
- have ALT greater than 3 x normal range
- have known cirrhosis of the liver
- have serum creatinine less than 133 umol/L
- abuse alcohol and recreational drugs
- be taking micronutrient (except vitamin D\*) or natural health product supplements within 30 days of randomization \*Maximum 2000 IU daily (Health Canada Guidelines).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2017
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00798772
Start Date
January 1 2009
End Date
December 6 2017
Last Update
April 17 2018
Active Locations (1)
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1
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6