A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects

Exclusion Criteria

• •5. Serum creatinine ≤ 1.5 ULN; serum bilirubin ≤ 2.0 ULN.
• •6. Total WBC ≥ 3000/mm3, platelet count ≥ 100,000/mm3 and granulocytes ≥ 1500 mm3.
• •7. Absolute CD4 cell count greater than 400 (based on the average CD4 count from the two pretherapy tests).
• •8. Hemoglobin \> 10.0 g/dl.
• •9. AST \< 4 times upper normal limit.
• •10. ALT \< 4 times upper normal limit.
• •11. Serum Albumin \> 2.0 g/dl.
• •12. Written informed consent.
• •13. Females must either be of non-child bearing potential, or utilize an effective form of contraception and have a negative pregnancy test within 14 days of entry.
• •14. For those subjects who are on antiretroviral therapy, they must have been on a stable dose schedule for at least 90 days prior to study entry and must continue on the same schedule during the treatment phase of this study.
• •1. Pregnant or nursing women, or women not using an effective form of contraception.
• •2. Less than 18 years of age.
• •3. Active IV drug users.
• •4. Absolute CD4 ≤ 400 mm3 (based on the average CD4 counts from the two pretherapy tests).
• •5. Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.
• •6. Receipt of any immunomodulator such as BCG vaccine, isoprinosine, or similar experimental agents within 45 days of study entry.
• •7. Evidence of chronic hepatitis, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurological, or psychiatric disorder that would limit the subject's ability to complete the study period.
• •8. Unlikely or unable to comply with the requirements of the protocol.
• •9. Patients unwilling or unable to give informed consent.
• •10. Patients on any other concurrent experimental medication.
• •11. Concurrent, chronic prophylactic use of any systemic antifungal medication (e.g. ketoconazole, fluconazole, clotrimazole) or of any systemic anti-viral (e.g. acyclovir or ganciclovir) except for antiretroviral therapy.
• •12. Patients using any form of interferon therapy during the 6 weeks prior to study entry. If prior interferon therapy has been received, the subject must not have known development of antibodies to interferon.
• •13. Hospitalized subjects, or those with an active viral infection other than HIV, within 2 weeks of study entry.
• •14. Transfusion dependent subjects (subjects requiring \> 1 unit of packed RBC per month within the 3 months prior to study entry).
• •15. Subjects who are symptomatic of their HIV infection at study entry.