Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection
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 improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.


Options:
A: Inclusion Criteria:

* men or women aged \>=18 years old
* HIV-positive
* initiating anti-retroviral therapy at the time of randomization or have been on highly active anti-retroviral therapy (HAART) for no more than 6 months
* have no intention of migrating, or re-locating \>= 20 km outside of the Infectious Disease Institute (IDI), or Kiswa Health Center within the next 18 months after enrollment
* agree to allow home visit(s) and subsequent follow-up contacts as part of the study
* provide written informed consent

Exclusion Criteria:

* pregnant Women
* individuals from whom we are unable to obtain written informed consent will be excluded from the study. For example, patients that are extremely ill and unable to consent will be excluded.
B: 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).
C: Inclusion Criteria:

* HIV infected
* HIV-RNA \< 400 copies/ml at study entry and for 12 wks. prior
* 25-hydroxyvitamin D level \<20
* On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry

Exclusion Criteria:

* Pregnancy or Breast Feeding
* Diabetes
* Creatinine Clearance \<50
* Any active infectious or inflammatory condition
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 within 6 months prior to study entry
D: Inclusion Criteria:

* HIV-positive
* Men or Women
* 18 Years of Age or older
* Initiating HAART at time of randomization

Exclusion Criteria:

* Pregnant or Lactating Women
* Individuals at pre-HAART disease stages
* BMI less than 16

Answer: B