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Protocol Number:
00-I-0071
- Title:
Randomized, Open-Label, Phase III, International Study of Recombinant IL-2 (Proleukin) in Pts. w/HIV-1 Infection and CD4 Cell Counts Greater than or Equal to 300 Cells/mm3: Eval of Subcutaneous Proleukin in Randomized International Trial (ESPIRIT)
- Number:
00-I-0071
- Summary:
This study will test whether the drug Interleukin-2 (IL-2), given together with antiretroviral drugs, can reduce the number of serious infections or prolong survival in people with HIV infection. IL-2 is a protein naturally produced by white blood cells called lymphocytes, which are important cells of the immune system. Lymphocytes from patients with HIV do not produce IL-2 normally and the total numbers of lymphocytes gradually decline with progressive disease. Administration of IL-2 has been shown capable of increasing the number of lymphocytes in treated patients above that usually reached through use of antiretroviral drugs alone.
Patients with HIV infection 18 years and older who have no symptoms of significant HIV illness and no history of opportunistic infections may be eligible for this 6-year study. Candidates will be screened with a medical history and physical examination, including blood tests and urinalysis. Those enrolled in the study will be randomly assigned to one of two treatment groups, as follows:
Group 1 will receive antiretroviral therapy alone. Patients in this group will be evaluated every 4 months with a physical examination and blood tests.
Group 2 will receive antiretroviral therapy plus IL-2. In addition to antiretroviral drugs, patients will receive IL-2 injections under the skin twice a day, 5 days a week (one treatment cycle). The 5-day cycle will be repeated every 8 weeks for 3 cycles. Subsequent cycles will be scheduled based on the treatment response. Outpatients will be taught how to self-administer injections.
Group 2 patients will be evaluated with a physical examination and blood tests every month for the first 6 months of treatment. Subsequent visits will be scheduled on an individual basis, but will be no less often than once every 4 months. Patients may need to be monitored daily during the 5 days of each injection cycle. Blood tests will also be done on day 5 of the first cycle and 1 month after the first cycle to evaluate drug side effects for possible dosage adjustments.
- Sponsoring Institute:
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National Institute of Allergy and Infectious Diseases (NIAID)
- Recruitment Detail
- Type:
Completed Study; data analyses ongoing
- 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):
-
Immune Restoration
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Antiretroviral
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Immunmodulator
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Disease Progression
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Six Year Duration
- Recruitment Keyword(s):
-
HIV
-
AIDS
- Condition(s):
-
HIV Infection
- Investigational Drug(s):
-
Interleukin-2
- Investigational Device(s):
- None
- Interventions:
-
Drug: Interleukin-2
- 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):
-
Alterations in the immune response of human immunodeficiency virus (HIV)-infected subjects treated with an HIV-specific protease inhibitor, ritonair
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HIV infection induces changes in CD4+T cell phenotype and depletions within the CD4+T cell repertoire that are not immediately restored by antiviral or immune-based therapies
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Antiretroviral therapy for HIV infection in 1997
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