Study on Interleukin-7 (CYT107) in HIV Patients (Inspire 2)

This study will evaluate the biological activity and pharmacokinetics of 20µg/kg/week of Interleukin-7 (CYT107).

This is a phase IIa study assessing weekly doses of CYT107 in addition to antiviral treatment in adult patients with HIV.

Study patients will receive a subcutaneous administration of CYT107 per week for a total of 3 weeks.

12 patients will be included in the study for a duration of approximately 1 year. During the study patients will continue their usual antiretroviral treatment.

During the study visits the following may be done:

• Medical history, physical examination, blood tests every visit.
• Electrocardiogram (EKG)
• Chest x-ray study
• Liver/spleen imaging
• Blood sample collections at frequent intervals
• Urine tests several times during the study.

Inclusion Criteria:

• HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western Blot at any time prior to study entry.
• Age ≥18.
• On HAART for at least 12 months, on stable regimen for at least 3 months prior to enrollment. HAART is defined as a combination of 2 classes dose regimen of approved ARV.
• CD4 cell counts ≥ 101 and < 400 cells/mm3 on two (2) consecutive measurements (including the screening value) within the previous 12 months prior to enrollment.
• Plasma HIV RNA < 50 copies/mL on at least two consecutive measurements (including the screening value) within the previous 6 months prior to enrollment. Note: Patients with single blip of detectable viremia during this period (6 months prior screening) will be allowed to participate if the prior and subsequent plasma HIV RNA levels are below the limits of detection.
• No AIDS-defining illness (category C) diagnosed within the last 6 months prior to enrollment.

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).