- HIV infected man or woman at least 18 years of age who is available for a follow up
period of at least 3 months
- Has been on a stable antiretroviral regimen for ≥3 months and willing to remain on
current antiretroviral regimen for an additional 3 months or has been off of
antiretroviral therapy for at least 8 weeks and willing to remain off of
antiretroviral therapy for another 3 months
- Plasma HIV 1 RNA ≥5,000 copies/mL measured by Roche Amplicor HIV 1 Monitor at the
screening visit
- CD4 T-cells ≥200 cells/mm3
- History of, or significant evidence of risk for, chronic inflammatory or
autoimmunedisease (eg, Addison's disease, asthma, celiac disease, multiple sclerosis,
Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis,
rheumatoid arthritis, systemic lupus erythematosus, etc)
- History of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis),
celiac disease, or other chronic gastrointestinal conditions associated with
diarrhea, or current acute colitis of any origin, and any history of diverticulitis
(even a single episode) or evidence of diverticulitis at baseline, including evidence
limited to CT-scan only
- Exposure within the previous 3 months to a drug known to have immunomodulatory
effects (eg, IL 2)