Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy

Study Overview
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Brief Summary
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The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. IL-2 may be able to boost the immune systems of people with HIV infection.

Detailed Description
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This study takes place in two phases. Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels. Ascending dose cohorts of five patients are studied. The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD. Phase B involves randomization of 190 patients to (a) one of three dose levels of L2-7001 plus ART, (b) one of two dosing levels of Proleukin plus ART, or (c) ART alone. L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles. Serum IL-2 levels, soluble IL-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B. All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001.

Official Title
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A Bridging Dose-Escalation Study of the Safety, Pharmacokinetic Properties, and Immunologic Effect of Subcutaneous L2-7001 (Recombinant Human Interleukin-2) in Patients Infected With HIV With CD4+ T-Cell Counts of 300 to 500 Cells/mm3 and Viral Burden Under 10,000 Copies/Ml on Active Antiretroviral Therapy (ART)

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Aldesleukin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load below 10,000 copies/ml. Have a CD4 count between 300 and 500 cells/mm3. Have been on stable anti-HIV therapy for 4 months. Patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (NNRTI). Are at least 18 years old. Agree to use an effective barrier method of birth control, such as condoms, during the study. Exclusion Criteria Patients will not be eligible for this study if they: Have an AIDS-defining illness. (Patients who have had an AIDS-defining illness that was cured may still be eligible.) Have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate. Have cancer requiring chemotherapy. Have a history of autoimmune disease. Have uncontrolled diabetes or certain thyroid problems. Have mental illness or other serious medical condition that the doctors feel would affect their ability to participate. Have received IL-2 in the past. Have taken corticosteroids or certain medications that affect the immune system in the past 4 weeks. Have taken hydroxyurea in the past 4 months. Are pregnant or breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aldesleukin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recombinant Proteins, Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Pharmacokinetics