Micronutrients and Antioxidants in HIV Infection (MAINTAIN)
HIV Infection
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV infection, Micronutrients, Antioxidants
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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).
Sites / Locations
- The Ottawa Hospital, General Campus
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
A: Broad spectrum micronutrients
B: Identical appearing multivitamins
The experimental treatment medications (micronutrients and antioxidants) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week. The intervention will last for two years.
The active comparator/control medications (identical appearing RDA multivitamins and minerals) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week. The intervention will last for two years.