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

Sponsor

Chiron Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00002449

Collaborator

(none)

212

Enrollment

Locations

9.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Aldesleukin	Phase 1

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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)

Study Start Date :

Aug 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sorra Research Ctr / Med Forum	Birmingham	Alabama	United States	35203
2	Pacific Oaks Research	Beverly Hills	California	United States	90211
3	Orange County Ctr for Special Immunology	Fountain Valley	California	United States	92708
4	St Lukes Medical Group	San Diego	California	United States	92101
5	Kaiser Foundation Hospital	San Francisco	California	United States	94118
6	Denver Inf Disease Consultants	Denver	Colorado	United States	80220
7	Dupont Circle Physicians Group	Washington	District of Columbia	United States	200091104
8	Community AIDS Resource Inc	Coral Gables	Florida	United States	33146
9	Steinhart Medical Associates	Miami	Florida	United States	33133
10	Specialty Med Care Ctrs of South Florida Inc	Miami	Florida	United States	33142
11	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
12	Northstar Med Clinic	Chicago	Illinois	United States	60657
13	Fenway Community Health Ctr	Boston	Massachusetts	United States	02115
14	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
15	Albany Med College	Albany	New York	United States	12208
16	Anderson Clinical Research Inc	Rego Park	New York	United States	11374
17	Associates in Med and Mental Health	Tulsa	Oklahoma	United States	74114
18	Research and Education Group	Portland	Oregon	United States	97210
19	Anderson Clinical Research	Pittsburgh	Pennsylvania	United States	15221
20	Central Texas Clinical Research	Austin	Texas	United States	78705
21	N Texas Ctr for AIDS & Clin Rsch	Dallas	Texas	United States	75219
22	Gathe, Joseph, M.D.	Houston	Texas	United States	77004
23	Virginia Mason Med Ctr	Seattle	Washington	United States	98101