Safety Study of IL-7 in HIV-infected Patients (Inspire)

Exclusion Criteria

• •1. Dual or single antiretroviral therapies with nucleoside analogs.
• •2. Enfuvirtide or any other investigational antiretroviral agent.
• •3. Any planned or probable modification of the antiretroviral treatment during the 3-month study period.
• •4. Current or recent history (less than 30 days prior to screening) of a viral, bacteria, parasitic or fungal infection requiring systemic treatment and/or hospitalization.
• •5. Positive PPD (North American subjects, except those who have received and completed INH prophylaxis).
• •6. Any serious illness requiring systemic treatment and/or hospitalization until the patient either completes therapy or is clinically stable on therapy, in the opinion of the principal investigator, for at least 28 days prior to study entry.
• •7. Any history of malignancy (except basal carcinoma of the skin) including any hematologic malignancy or AIDS defining malignancy, such as lymphoproliferative disorder or Kaposi's sarcoma. (Patients with Kaposi's sarcoma limited to the skin that disappeared while on HAART therapy, and without requiring any other systemic therapy, 1 year prior to study entry will be eligible to participate).
• •8. Any history of HIV related encephalopathy.
• •9. Hepatitis B or C (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load or positive anti HCV antibodies with a detectable HCV RNA viral load). Patients who became negative to HBV DNA or HCV RNA following an antiviral treatment should not be enrolled.
• •10. HIV-2, HTLV-1 and HTLV-2 seropositivity.
• •11. Pregnant or lactating women. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry.
• •12. Refusal or inability to practice contraception during therapy regardless of the gender of the patient.
• •13. Participation in another investigational interventional study during this study or within the last 6 months.
• •14. Family history of sudden cardiac death.
• •15. Corrected QT interval (QTc) prolongation defined as a QTc greater than or equal to 470 ms or a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities.
• •16. Any history of severe auto-immune disease requiring systemic treatment or hospitalization, or any active auto-immune disease requiring treatment.
• •17. Any cardiac, pulmonary, thyroid, renal, hepatic, neurological (central or peripheral) disease requiring therapy and considered as significant by the investigator or a severe disorder of hemostasis.
• •18. Cirrhosis of any origin, and alcoholic or non alcoholic steatohepatitis, either proven histologically or only suspected.
• •19. Any gastrointestinal illness associated with chronic or intermittent diarrhea.
• •20. Hypertension with a resting systolic blood pressure greater than 140 mmHg or a resting diastolic blood pressure greater than 90 mmHg despite adequate antihypertensive treatment.
• •21. Use of tipranavir/ritonavir (TPV/r).
• •22. Previous treatment with IL-2 or IL-7 at any time prior to study entry.
• •23. Prior treatment with immunomodulatory agents such as growth factors, immunosuppressive drugs, cytotoxic chemotherapy or hydroxyurea within 3 months of study entry.
• •24. Use of systemic corticosteroids within 3 months prior to enrollment.
• •25. Any vaccination within 30 days prior to study entry and during the study (until follow-up at W12).
• •26. Need for anticoagulant medication.
• •27. History of splenectomy.
• •28. Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's disease, and autoimmune haemolytic anemia.
• •29. Nephrological abnormalities: Calculated creatinine clearance less than 90 ml/min (according to Cockroft formula) or proteinuria greater than 300 mg/l.
• •30. Other abnormal laboratory findings: hemaglobin less than 10g/dl; Neutrophils less than 1,000/mm(3); Platelets less than 100,000/mm(3); AST, ALT, or Alk. Phosph. greater than 2.5 x ULN; Total bilirubin greater than 1.5 x ULN (or greater than 5 x ULN if the patient is treated by atazanavir or by indinavir, and if the increase is due to unconjugated bilirubin and if liver enzymes are normal); Lipase greater than 2 x ULN; PT/PPT greater than 1.5 x ULN.
• •31. Poor compliance on HAART or any other chronic treatment in the opinion of the investigator.
• •32. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. Patients must agree to refrain from substance abuse use during the course of the study.
• •33. Any past or current psychiatric illness that, in the opinion of the investigator, would interfere with adherence to study requirements or the ability and willingness to give written informed consent.