Clinical trial NCT00002449: Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: HIV Infections
Keywords: Recombinant Proteins
Injections, Subcutaneous
Interleukin-2
Dose-Response Relationship, Drug
CD4 Lymphocyte Count
Anti-HIV Agents
Viral Load
Pharmacokinetics
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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