Interluekin-7 to Treat HIV-Infected People Receiving Antiretroviral Treatment
Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
Participant gender:
Summary
This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7
protein produced by the body, is safe to use in people infected with HIV. IL-7 is important
in immune system function. In humans, it can extend the life of immune cells called T-cells
and increase their function and maturation; in mice, it can speed up immune system recovery
following chemotherapy of transplantation; and in monkeys, it can make T-cells increase in
numbers. If this study shows that IL-7 is safe, other trials will determine if it can improve
the numbers or function of T-cells in HIV-infected people.
Patients 18 years of age and older with HIV infection who have been taking anti-HIV
medications for at least 12 months, whose CD4 counts are at least 100 cells/microliter, and
whose viral load is no more than 50,000 copies/milliliter may be eligible for this study.
Candidates are screened with a physical examination, blood and urine tests, including a blood
test for HLA type (a genetic test of markers of the immune system), chest x-ray,
electrocardiogram, and ultrasound of the spleen.
Participants undergo the following tests and procedures during 9 visits, as follows:
Pre-entry visit
- Brief physical examination, including examination of lymph nodes and spleen.
- Medical history, including questions about current and past medications.
- Urine pregnancy test for women who are able to become pregnant.
- Blood draw for viral load, immune responses, and other routine safety tests.
Entry visit
- Complete physical examination, including examination of lymph nodes and spleen.
- Routine urine test and urine pregnancy test for women who are able to become pregnant.
- Blood draw for viral load, immune responses, and other routine safety tests.
- IL-7 dosing. Participants are randomly assigned to receive one of five doses of IL-7 (3,
10, 30, 60 or 100 micrograms per kilogram of body weight) or placebo (a salt solution
that does not contain IL-7). The dose may be given in one or more injections, with
higher doses possibly requiring as many as seven or eight injections. The injections are
given subcutaneously (under the skin), usually in the arm or leg. After the injection,
patients are monitored closely for 12 hours for skin or allergic reactions. Blood is
drawn before the injection and again at 0.5, 1, 1.5, 2, 2.5, 4, 8 and 12 hours after the
injection to check blood levels of the study medication.
Follow-up visits
Patients come to the clinic 7 times during follow-up-every day for the first 4 days after the
injection, then at 14 days, 4 weeks, and 8 weeks after the injection. At most study visits,
patients have the following procedures:
- Brief physical examination, including examination of lymph nodes and spleen.
- Routine urine test and urine pregnancy test for women who are able to become pregnant.
- Blood draw for viral load, immune responses, and other routine safety tests.
- Blood test to measure the amount of study medication in the blood 1, 2, and 3 days after
the injection
- Electrocardiogram 1 day after the injection
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)