Study on Interleukin-7 (CYT107) in HIV Patients

Exclusion Criteria

• •Use of any other investigational antiretroviral agents.
• •Any planned or probable modification of the anti-retroviral treatment during the first 3 month study period.
• •Current or recent history (\<30 days prior to screening) of a viral, bacterial, parasitic or fungal infection requiring systemic treatment and/or hospitalization.
• •Positive PPD unless there is documentation of completion of INH therapy for latent tuberculosis.
• •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 .
• •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).
• •Any history of HIV related encephalopathy.
• •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.
• •HIV-2, HTLV-1 or HTLV-2 seropositivity.
• •Pregnant or lactating women. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry.
• •Refusal or inability to practice contraception regardless of the gender of the patient.
• •Hypertension with a resting systolic blood pressure \> 140 or a resting diastolic blood pressure \> 90 mm despite adequate antihypertensive treatment.
• •Use of tipranavir/ritonavir (TPV/r) and Enfuvirtide (T-20).