Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV

Exclusion Criteria

• •Confirmed clinical history of developing resistance to ART regimens that resulted in treatment changes
• •Receiving didanosine as part of the participant's ART regimen at the time of screening
• •Ongoing treatment with Isoniazide, pyrazinamide, Rifabutin, Rifampicin, Diadenosine Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
• •Use of any investigational drug within 30 days prior to screening
• •History or current use of immunomodulatory therapy for over 2 weeks during the 6 months prior to enrollment, including, but not limited to: IFN-alpha or gamma (recombinant or pegylated), systemic corticosteroids (nasal or pulmonary steroids will be allowed; systemic cancer chemotherapy/irradiation; cyclosporin; tacrolimus (FK-506); OKT-3; any Interleukin, including IL-2; cyclophosphamide; methotrexate; IVIG (gamma globulin); G/M-CSF; hydroxyurea; thalidomide; pentoxifylline; thymopentin; thymosin; dithiocarbonate; polyribonucleotide.
• •History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-alpha2a, IFN-α2b, IFN-beta)
• •History of severe depression, or ongoing moderate depression determined by PHQ-9 at screening
• •Type I diabetes mellitus, or type II diabetes mellitus that is not controlled with oral agents and/or insulin.
• •Prior diagnosis of multiple sclerosis or other neurodegenerative disorders
• •Significant co-existing lab abnormalities including:
• •1. Anemia (Hgb \<9.1 mg/dl men, \<8.9 mg/dl women)
• •2. WBC \<2000 cells/µl
• •3. Absolute neutrophil count (ANC) \<1200 cells/ µl
• •4. Platelet count \<60,000 cells/ µl
• •5. Liver disease (AST/ALT \> 2.5x, Total Bilirubin \> 1.5x upper limits of norm (ULN), or Total Bilirubin \>3x ULN if receiving indinavir OR Atazanavir)
• •6. Renal disease (creatinine \> 2x upper normal limits or creatinine clearance \<60mg/dl (by Crockoff-Gault)
• •Chronic HCV infection (HCV viremia), or HBV Ag positive and/ or HBV viremia (Notice: subjects with prior HCV infection with a documented sustained virologic response with treatment finishing \>1 year prior to screening are eligible for enrollment).
• •Liver cirrhosis or hepatic decompensation with Child Pugh score \> 6
• •History of major organ transplantation with an existing functional graft.
• •Evidence of OI or other active infectious diseases or active malignancies
• •Active Autoimmune diseases, including autoimmune hepatitis
• •History of retinopathy or clinically significant ophthalmologic disease on eye exam performed within 6 months prior to initiation of IFN
• •Pregnancy, actively attempting to become pregnant, or breastfeeding
• •Body weight under 125 lbs or over 300 lbs
• •Other conditions, such as active drug/alcohol abuse or dependence which would interfere with study compliance