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

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)

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002449

Enrollment

212

Registered

2001-08-31

Start date

1999-08-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Recombinant Proteins, Injections, Subcutaneous, Interleukin-2, Dose-Response Relationship, Drug, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Pharmacokinetics

Brief summary

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

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.

Interventions

DRUGAldesleukin

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026