Effect of Interferon Alpha 2b Intensification on HIV-1 Residual Viremia in Individuals Suppressed on Antiretroviral Therapy

Inclusion Criteria

- INCLUSION CRITERIA:

To be eligible for study participation, a volunteer must satisfy all of the following
inclusion criteria:

1. Age greater than or equal to 18 years.

2. Documentation of HIV-1 infection by any licensed ELISA test and confirmed by a
Western Blot.

3. Receiving a DHHS-approved ARV regimen.

4. HIV-1 RNA levels less than detectable by current commercial means (e.g., Roche
Amplicor, b-DNA test) for a minimum of 12 months prior to screening at all time
points, and with at least 2 measurements in this 12 month window.

5. HIV-1 RNA levels greater than or equal to 0.6 copies/mL by SCA at screening visit.

6. CD4 greater than or equal to 300 cells/mm(3) at pre-entry visit within 14 days prior
to enrollment.

7. Ability to sign informed consent and willingness to comply with the study
requirements and clinic policies.

8. No evidence of viral hepatitis co-infection as assessed by Hepatitis C antibody, HCV
RNA, and hepatitis B surface antigen; determinations at pre-entry visit within 28
days prior to enrollment.

9. No history of or evidence of autoimmune hepatitis or other autoimmune disorders at
screening, or Antinuclear antibody (ANA > 3 times upper limit of normal.

10. Laboratory values at pre-entry visit within 14 days prior to enrollment:

- Alkaline phosphatase < 2.0 times upper limit of normal

- Alanine transaminase (ALT) < 2.0 times upper limit of normal

- Total bilirubin < 2.5 mg/dL (< 40 mg/dL if on Atazanavir)

- Creatinine clearance greater than or equal to 60 mL/min as estimated by the
Cockcroft-Gault equation

- Neutrophil count greater than or equal 1500 cells/mm(3)

- Platelets greater than or equal to 150,000/ mm(3)

- Hemoglobin greater than or equal to 12.0 mg/dL for men and > 11.0 g/dL for women

- Fasting glucose < 126 mg/dL

11. No history or evidence of significant clinical depression at screening that in the
opinion of the investigator would affect the ability of the patient to participate in
the study, or which would constitute a threat for his/her health in case of relapse
upon INF treatment. The Beck Depression Inventory score must be less than or equal to
13 at pre-entry visit.

12. No history of INF/PEG-INF therapy.

13. If capable of pregnancy: use of effective contraception during study: effective
contraception methods include abstinence, surgical sterilization of either partner,
barrier methods such as diaphragm, condom, cap or sponge, or use of hormonal
contraception with an anti-HIV regimen that will not alter metabolism of hormonal
contraception.

14. Participants must have primary medical care outside this protocol: participants will
have to provide Primary Care Doctor's contact information.

EXCLUSION CRITERIA:

A volunteer will be ineligible to participate in this study if any of the following
criteria are met:

1. History of neoplastic disease requiring cytotoxic therapy including hydroxyurea.

2. Use of long-term systemic corticosteroids, immunosuppressive agents, or cytotoxic
agents within 60 days prior to enrollment.

3. Any vaccination within 30 days prior to enrollment. Individuals interested in
participating who require vaccination will delay screening until 30 day period is
completed.

4. Concurrent therapy with investigational cytokines including IL-2 or IL-12 during the
course of the study. Prior administration of cytokines is not an exclusion criterion;
at least 4 months from most recent cycle of IL-2 or IL-12 is required.

5. Any febrile illness (> 38 degrees C) in the 3 weeks prior to enrollment or any acute
therapy for a serious infection completed within 30 days prior to enrollment.

6. Current pregnancy or lactation, history of pregnancy in the last 4 months.

7. Preexisting autoimmune disorders including inflammatory bowel diseases, psoriasis,
idiopathic thrombocytopenic purpura, lupus erythematous, autoimmune hemolytic anemia,
scleroderma, severe psoriasis, rheumatoid arthritis, and optic neuritis.

8. History of severe retinopathy or evidence of severe retinopathy judged by pre-entry
ophthalmologic examination.

9. Known allergy/sensitivity to study drug or its formulation.

10. History of seizure disorders or current anticonvulsant use.

11. Any history of medical conditions associated with chronic liver disease (genetic
hemochromatosis, alcoholic liver disease, toxin exposures, and autoimmune hepatitis)
or documented cirrhosis due to any cause.

12. History of pulmonary disease associated with functional limitation.

13. Documented history of thyroid disease.

14. Active drug or alcohol use or dependence, which in the opinion of the investigator,
would interfere with complying with the study requirements.

15. Known hypersensitivity to Escherichia coli-derived products such as filgrastim.

16. Any systemic illness that will make it unlikely that the subject will be able to
return for the required study visits.

17. History of, or any condition that in the opinion of the investigator would interfere
with the conduct of the study, or it would not be in the best interest of the subject
to enroll in this study.