Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection

Inclusion Criteria

• Male or female, age ≥ 18 but 6 months ≥ 400 CD4+ T cells/mm3 (CD4 nadir ≥ 200 cells)
• Female subjects with childbearing potential: negative pregnancy test (Beta human horionic gonadotropin (HCG)). Must agree to use appropriate contraceptive methods (barrier devices such as diaphragms or condoms + spermicidal or intrauterine device (IUD) or oral contraceptives) while on study.
• Karnofsky performance scale score of 80% or better
• Willing to adhere to the treatment and schedule approved by the study investigators in conjunction with the patient's primary provider.
• Willing to abstain from immunomodulatory drugs during the study period, with the exception of the study drug (Pegasys®).
• Patient Health Questionnaire (PHQ)-2 score 45yrs men/>55yrs women years of age or if below these years of age but with two added risk factors for coronary artery disease [smoking, hypertension (BP >140/90 or on antihypertensive medications), low Hight density lipoprotein (HDL)-associated cholesterol ( 15% (men) or 10% (women))

Exclusion Criteria

• Currently pregnant or breast feeding.
• CD4 cell count 5x, Total Bilirubin > 1.5x upper limits of normal, or Total Bilirubin >3x upper limit of the norm (ULN) if receiving indinavir), Renal disease (creatinine > 2x upper normal limits), or other conditions, such as active drug/alcohol abuse or dependence which would interfere with study compliance.
• Any history of heart attacks, myocardial infarction or coronary arterial disease (MI/CAD). .
• Prior history of major depression or other severe psychiatric disorder/condition requiring treatment and/or hospitalization
• PHQ-9 score >14, OR PHQ-9 score > 10 - 14 and lack of medical provider's favorable opinion, or score for PHQ-9 answer # 9 (suicidal ideation) > 0.
• Evidence of chronic active Hepatitis B infection (Surface Antigen HBsAg) or Hepatitis C plymerase chain reaction (PCR) positivity at screening (cleared of HCV at entry >6 months).
• Past evidence of medical conditions associated with chronic liver disease including genetic hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures etc.
• History of neutropenia or other hematological abnormalities
• Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin.
• Ongoing treatment with Isoniazide, Pyrazinamide, Rifabutin, Rifampicin, Diadenosine Ganciclovir, Valganciclovir, Oxymetholone, Thalidomide or Theophylline.
• History of autoimmune processes including Crohn's disease, ulcerative colitis, severe psoriasis, rheumatoid arthritis, myositis, hepatitis etc.
• History of major organ transplantation with an existing functional graft.
• Active coronary artery disease within 24 weeks prior to study
• Hemoglobinopathies such as sickle cell anemia or Thalassemia major.
• Hypersensitivity to Pegasys®or any of its components.