Reducing Proviral HIV DNA With Interferon-a

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 Isoniazid, Pyrazinamide, Rifabutin, Rifampicin, Ganciclovir, Valgancyclovir, Oxymetholone, Thalidomide or Theophylline.
• •Ongoing treatment with anticoagulants
• •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-α or γ (recombinant or pegylated), systemic corticosteroids (inhaled steroids allowed at the discretion of the Investigator); 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; polyribonucloside.
• •History of adverse or allergic reactions to any type-1 interferon (e.g. IFN-α2a, IFN-α2b, IFN-β)
• •Current or prior clinical conditions
• •History of severe depression, including history of suicidal ideation or attempt, 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 (i.e.: subjects with a history of diabetes mellitus and HA1C of \> 9 in the last 3 months or at screening).
• •Prior diagnosis of multiple sclerosis or other neurodegenerative disorders
• •Significant co-existing lab abnormalities including: a) Anemia (Hgb \<9.1 mg/dl men, \<8.9 mg/dl women); b) Ongoing coagulopathy/clotting disorder; c) WBC \<2000 cells/µl; d) Absolute neutrophil count (ANC) \<1200 cells/ µl; e) Platelet count \<60,000 cells/ µl; f) Liver disease (AST/ALT \> 2.5x OR total bilirubin \> 1.5x upper limits of norm (ULN), (if not receiving atazanavir) or direct bilirubin \> 0.6 (if receiving atazanavir); g) Pancreatic disease (amylase : \> 1.5 ULN, lipase \> 1.5 ULN, triglycerides \> 750 mg/dl); h Renal disease (creatinine \> 2x ULN 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 60 days prior to initiation of IFN
• •Significant EKG abnormalities (see section 7.4)
• •Other conditions
• •Pregnancy or breastfeeding
• •A planned pregnancy during study participation
• •Lack of one of three strategies for birth control during study participation: a) Barrier contraceptives (male or female condoms with or without a spermicidal agent, diaphragm or cervical cap with spermicidal); b) Non-hormonal Intrauterine Devices (IUDs); c) Hormonal-based, including hormonal IUDs, in combination with barrier contraceptives.
• •Body weight \< 125 lbs or \> 300 lbs
• •Other conditions, such as active drug/alcohol abuse or dependence,that in the opinion of the Investigator would interfere with study compliance.