Safety Study of IL-7 in HIV-infected Patients (Inspire)
Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
Summary
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.