Protocol Number: 05-I-0123

Title:

A Randomized, Open-Label, International Study of Subcutaneous Recombinant Interleukin-2 (rIL-2, Aldesleukin) with and without Concomitant Antiretroviral Therapy in Participants w/HIV-1 Infection and CD4+ Cell Counts Greater Than or Equal to 300/mm(3)

Number:

05-I-0123

Summary:

This study will determine the safety and side effects of interleukin-2 (IL-2) taken with or without anti-HIV drugs and will see if IL-2 with or without anti-HIV drugs causes an increase in CD4 cells or a change in HIV viral load compared with no therapy at all. IL-2 is a protein that is produced naturally in the body and helps boost production of infection-fighting CD4 cells.

HIV-infected patients 18 years of age and older who have not previously taken IL-2 or taken any anti-HIV drug within 1 year of entering this study may be eligible for the study. Candidates are screened with a physical examination and blood tests during at least two screening clinic visits.

Participants are assigned by chance to one of the following three treatment groups:

-Standard of care treatment: This group does not receive IL-2 or anti-HIV drugs.

-IL-2 alone: This group receives three treatment cycles of IL-2. A cycle consists of an injection of IL-2 under the skin twice a day for 5 days in a row, followed by 7 weeks of no IL-2. After three cycles, patients may continue additional cycles for up to 2 years if the therapy is believed to be helpful. Patients are taught how to self-administer the IL-2.

-IL-2 plus anti-HIV drugs around IL-2 cycles only: This group receives three cycles of IL-2 as outlines above, but also receives 10 days of anti-HIV drugs around the IL-2 cycles (3 days before, 5 days during, and 2 days after IL-2 cycles).

Patients in the first two groups may begin anti-HIV therapy at any time they or their doctors believe it would be in their best interest to do so, and patients in the third group may begin continuous anti-HIV therapy or, conversely, stop all anti-HIV drugs, at any time it is believed to be in their best interest to do so.

All patients are followed in the clinic at least once a month for 8 months and then at least every 4 months for up to 2 years. The follow-up includes blood tests and possibly a visit with a doctor or nurse. Patients who develop side effects may need to be seen more frequently and may require additional blood and urine tests. Patients receiving IL-2 are seen for a clinical examination or blood tests, or both, to ensure that they are well before receiving each cycle. They are also seen on the last day of the dosing cycle and once again about one month after each cycle. They may need to be seen more often if they have a history of serious side effects during prior IL-2 treatments or if they develop serious side effects. Women who can become pregnant have a pregnancy test before starting each IL-2 cycle.

Some of the blood drawn for this study is used for genetic tests, and some blood is collected and stored for future studies.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: No longer recruiting/follow-up only

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):

Immunomodulator

Antiretroviral-Sparing

T Lymphocytes

Intermittent Therapy

Recruitment Keyword(s):

HIV

ARV

IL-2

HAART Naive

Condition(s):

HIV Infections

HIV

Investigational Drug(s):

Interleukin-2, Proleukin

Investigational Device(s):

None

Interventions:

Drug: Interleukin-2, Proleukin

Drug: Interleukin-2, Proleukin

Supporting Site:

National Institute of Allergy and Infectious Diseases

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):

Vittinghoff E, Scheer S, O'Malley P, Colfax G, Holmberg SD, Buchbinder SP. Combination antiretroviral therapy and recent declines in AIDS incidence and mortality. J Infect Dis. 1999 Mar;179(3):717-20.

Mocroft A, Vella S, Benfield TL, Chiesi A, Miller V, Gargalianos P, d'Arminio Monforte A, Yust I, Bruun JN, Phillips AN, Lundgren JD. Changing patterns of mortality across Europe in patients infected with HIV-1. EuroSIDA Study Group. Lancet. 1998 Nov28;352(9142):1725-30.

Palella FJ Jr, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998 Mar 26;338(13):853-60.

• 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.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009