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	Treatment or Intervention	Phase
HIV Infections	Drug: Aldesleukin	Phase I

Further Study Details: 

Expected Total Enrollment:  212

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  B007; CS-MM-9901
Record last reviewed:  July 2001
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002449
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08