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

Completed · Phase 1

Conditions studied: HIV Infections, Lymphopenia

In brief

This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T cells. If this study shows that IL-7 is safe, additional studies will be done to see if it can improve the function or numbers of T-cells in HIV-infected persons. HIV-infected persons who have been receiving HAART therapy for at least 12 months before enrolling in the study and have been stable on this treatment for at least 3 months before enrollment may be eligible for this study. Participants have about 10 clinic visits over 3 months. They receive three injections of IL-7, one injection a week for 3 consecutive weeks. The injections are given as a shot under the skin in the arm or leg. On the day of each injection, the participant stays in the clinic for up to 8 hours or longer for observation and collection of blood samples. Three additional visits (one every 3 months) may be scheduled. During the study visits the following may be done: * Medical history, physical examination, blood tests every visit. * Electrocardiogram (EKG) at study days 0 (day of first dose), 1, 7 (day of second dose), 14 (day of third dose) and 21. * Chest x-ray study on day 21. * Blood sample collections at frequent intervals during the first 96 hours after the first dose administration. A catheter (thin plastic tube) may be put into a vein in the arm and left in place to allow several blood samples to be drawn without repeated needle sticks. * Urine tests several times during the study.

Key facts

Study ID

NCT00477321

Run by

Cytheris SA

People needed

30

Starts

2007-05-01

Expected to finish

2010-07-01

Last updated by the study team

2012-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Dual or single antiretroviral therapies with nucleoside analogs.
• Enfuvirtide or any other investigational antiretroviral agent.
• Any planned or probable modification of the antiretroviral treatment during the 3-month study period.
• 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.
• Positive PPD (North American subjects, except those who have received and completed INH prophylaxis).
• 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.
• 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 and 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 during therapy regardless of the gender of the patient.
• Participation in another investigational interventional study during this study or within the last 6 months.
• Family history of sudden cardiac death.
• 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.
• Any history of severe auto-immune disease requiring systemic treatment or hospitalization, or any active auto-immune disease requiring treatment.
• 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.
• Cirrhosis of any origin, and alcoholic or non alcoholic steatohepatitis, either proven histologically or only suspected.
• Any gastrointestinal illness associated with chronic or intermittent diarrhea.
• 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.
• Use of tipranavir/ritonavir (TPV/r).
• Previous treatment with IL-2 or IL-7 at any time prior to study entry.
• Prior treatment with immunomodulatory agents such as growth factors, immunosuppressive drugs, cytotoxic chemotherapy or hydroxyurea within 3 months of study entry.
• Use of systemic corticosteroids within 3 months prior to enrollment.
• Any vaccination within 30 days prior to study entry and during the study (until follow-up at W12).

Where it is running

• University of Miami School of Medicine — Miami, Florida, United States
• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• McGill University Health Center (MUHC) — Montreal, Canada
• Hopital Henri Mendor-Service d'Immunologie Clinique — Créteil, France
• Hopital Kremlin Bicêtre — Le Kremlin-Bicêtre, France
• Hopital Saint Louis — Paris, France
• San Raffaele Scientific Institute — Milan, Italy

Full record on ClinicalTrials.gov

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