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NIAID HIV and Emerging Infectious Diseases Program |
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INSPIRE Study
Study Name: A Phase I/IIa Randomized Placebo Controlled, Single-Blind Multicenter Dose-Escalation Study of Subcutaneous Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Patients with CD4 T-Lymphocyte Counts between 101-400 Cells/mm(3) and Plasma HIV RNA Less Than 50 Copies/ml after at Least 12 Months of Highly Active Antiretroviral Therapy (HAART)
Study Number: #07-I-0155
Goal of Study:The NIH is conducting a research study to evaluate the safety and biologic activity of Interleukin-7 (IL-7), which is intended to increase the number and improve the function of T-lymphocytes in individuals with HIV infection. The study is placebo-controlled, and you will have a four times greater chance at getting actual IL-7 over the placebo (dummy drug). You will receive IL-7 (or placebo) by injection on three separate days and have about 13 visits over 52 weeks. Volunteers will be compensated.
Study Regimen:After screening for the study, you will receive IL-7 (or placebo) on the following days: 0, 7, and 14. You will have study visits at screening and days 0, 1, 4, 7, 14, 21, 28, 35, 56, and 77. Follow-up visits will occur at weeks 24, 36, and 52. During the study, we will perform routine physical exams and blood draws; an electrocardiogram (EKG); an ultrasound of your spleen; chest X-rays; and apheresis, a procedure that collects white blood cells.
Eligibility Criteria:
- You are 18 or older, with documented HIV infection.
- Your CD4 (T-cell) count is between 101 and 400.
- Your viral load has been <50 for at least six months before enrollment.
- You have been on anti-HIV medications for at least 12 months and have been using the same medications for at least the past 3 months.
- You have no serious diseases and infections.
- You are not pregnant.
- You have no history of cancer, seizures, liver infections, or uncontrolled high blood pressure.
- You are not taking enfuvirtide (T-20, a fusion inhibitor also called Fuzeon) or tipranavir (a protease inhibitor also known as Aptivus).
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