Status:
COMPLETED
Phase II/III Study Evaluating the Effect of IL-2 on Preservation of the CD4 T-Lymphocytes After Interruption of Antiretroviral Treatment in HIV-Infected Patients With CD4 T-Lymphocyte Count Greater Than 500 Cells/mm3 Who Received Antiretroviral Tx
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
ANRS, Emerging Infectious Diseases
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will examine whether interleukin-2 (IL-2) given before the interruption of antiretroviral (ARV) treatment could significantly extend the period of time that a patient is temporarily not tak...
Detailed Description
The use of antiretroviral (ARV) medications has greatly improved morbidity and mortality of HIV-infected patients but long-term use of these agents has been associated with significant toxicities and ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years.
- HIV-1 infection confirmed by ELISA and Western Blot before screening.
- Category A or B HIV-1 infection.
- Antiretroviral treatment:
- started at least 12 months prior to screening visit;
- stable and continuous for at least 12 weeks prior to screening visit;
- modified no more than once for virologic failure.
- IL-2 naive
- CD-4(+) T-lymphocyte count greater than or equal to 500 cells/mm(3) in the twelve weeks prior to screening (historical) and at screening.
- Nadir CD4(+) T-lymphocyte count greater than or equal to 200 cells/mm(3) prior to screening visit (that is, no measurement whose values may be less than 200/mm(3) since diagnosis of the HIV infection.
- Plasma HIV RNA less than 50 copies/ml in the 12 weeks preceding screening (historical, less than limit of detection if different method and/or cut off used) and at screening.
- For women of child-bearing age: use of effective contraception (hormonal such as birth control pill or injections, intrauterine device, surgical sterilization and/or mechanical barrier methods such as diaphragm or condoms); for all participants agreement to fully comply with prevention of transmission recommendations during periods of viremia if sexually active (latex condoms with or without additional barrier methods).
- Desire to interrupt antiretroviral therapy.
- Ability to sign informed consent (no later than W-2).
- EXCLUSION CRITERIA:
- Previous treatment with IL-2.
- Combined treatment with interferon, other interleukins, anti-HIV vaccines, systemic (not topical or inhaled) corticosteroids and hydroxyurea within the previous 12 weeks.
- Diagnosis of AIDS.
- Acute infection in the 14 days preceding inclusion.
- Pregnant, lactating woman desiring conception or not using contraception.
- Hemoglobin less than 10 g/dl; neutrophils less than 1,000/mm(3); platelets less than 50,000/mm(3); creatinine greater than 1.5 times the upper limit of normal (N); bilirubin greater than 3N; AST or ALT greater than 3 N.
- Progressive disease of malignant, psychiatric, cardiac, pulmonary, thyroid, renal or neurological (peripheral or central) origin or severe disorders of hemostasis.
- Severe uncontrolled hypertension.
- Previous or progressive pathology contraindicating the administration of IL-2.
- History of extensive psoriasis, Crohn's disease or auto-immune disease involving severe complications.
- HTLV-1 infection (ELISA positive).
- Hepatitis B virus co-infection treated with lamivudine or tenofovir or adefovir.
- Since atazanavir use can be associated with higher bilirubin levels (mostly indirect) in the absence of clinical consequences, subjects on atazanavir with bilirubin up to 4.5 times N may be allowed to participate if the levels have been stable and after approval by the PI or the PI designated covering physician.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00071890
Start Date
October 1 2003
End Date
December 1 2007
Last Update
October 5 2010
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
Hospital Henri Mondor
Créteil, France