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

Inclusion Criteria:

- 18-65 years of age

- Body weight between 125 and 299 lbs

- Confirmed diagnosis of HIV-1 infection by western blot or by a documented HIV-1 viral
load

- Currently receiving ART and on ART for > 1 year

- VL < 50 copies/ml for ≥ 1 year, with at least 2 measurements in the previous year, 1
viral "blip" with VL< 400 copies/ml allowed

- HIV viral load of <50 copies/ml at screening.

- CD4 >450 cells/µL at screening.

- A negative ECG if >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 HDL (<40 mg/dL), family history
of premature CHD (<55 yrs males/<65 females)] or a Framingham score > 15% (men) or
10% (women))

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