Protocol Number: 07-I-0155

Title:

A Ph I/IIa Rand Placebo Ctrl, S-Blind Multictr Dose-Esc Study of SC Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Pts with CD4 T Lymphocyte Counts 101-400 Cells-/mm(3) and Plasma HIV RNA Less Than 50 copies/mL After at Least 12 M of HAART

Number:

07-I-0155

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 pesrons 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) is 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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Recruitment has not started

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Interleukin 7

Immune Reconstitution

T Cell Turnover

CD4 Lymphenia

Immune-Based Therapies

Recruitment Keyword(s):

HIV Infection

Condition(s):

HIV Infections

Lymphopenia

Investigational Drug(s):

Interleukin-7

Investigational Device(s):

None

Interventions:

Drug: rhIL-7 (CYT 107)

Drug: Interleukin-7

Supporting Site:

National Institute of Allergy and Infectious Diseases, Cytheris, Inc.

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Stebbing J, Gazzard B, Douek DC. Where does HIV live? N Engl J Med. 2004 Apr 29;350(18):1872-80. Review. No abstract available.

Battegay M, Nuesch R, Hirschel B, Kaufmann GR. Immunological recovery and antiretroviral therapy in HIV-1 infection. Lancet Infect Dis. 2006 May;6(5):280-7. Review.

Douek DC, Picker LJ, Koup RA. T cell dynamics in HIV-1 infection. Annu Rev Immunol. 2003;21:265-304. Epub 2001 Dec 19. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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