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

HIV Infections Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002449
• Other study ID #: B007
• Secondary ID: CS-MM-9901
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005
• Start date: August 1999

Study information

• Verified date: July 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 212
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Aldesleukin

Locations

Country	Name	City	State
United States	Albany Med College	Albany	New York
United States	Central Texas Clinical Research	Austin	Texas
United States	Pacific Oaks Research	Beverly Hills	California
United States	Sorra Research Ctr / Med Forum	Birmingham	Alabama
United States	Fenway Community Health Ctr	Boston	Massachusetts
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Northstar Med Clinic	Chicago	Illinois
United States	Community AIDS Resource Inc	Coral Gables	Florida
United States	N Texas Ctr for AIDS & Clin Rsch	Dallas	Texas
United States	Denver Inf Disease Consultants	Denver	Colorado
United States	Orange County Ctr for Special Immunology	Fountain Valley	California
United States	Gathe, Joseph, M.D.	Houston	Texas
United States	Specialty Med Care Ctrs of South Florida Inc	Miami	Florida
United States	Steinhart Medical Associates	Miami	Florida
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Anderson Clinical Research	Pittsburgh	Pennsylvania
United States	Research and Education Group	Portland	Oregon
United States	Anderson Clinical Research Inc	Rego Park	New York
United States	St Lukes Medical Group	San Diego	California
United States	Kaiser Foundation Hospital	San Francisco	California
United States	Virginia Mason Med Ctr	Seattle	Washington
United States	Associates in Med and Mental Health	Tulsa	Oklahoma
United States	Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Chiron Corporation

Country where clinical trial is conducted

United States,