A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3

This study is currently recruiting patients.

Sponsored by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system. IL-2, given through injection under the skin, in combination with anti-HIV therapy can increase CD4 cell counts. This study examines 3 doses of IL-2 in order to determine the safest and most effective dose to use. This is a Phase II trial (a study that examines a drug's effectiveness and looks for side effects). It is part of a worldwide study and will be conducted in Houston, TX. You will be assigned to 1 of 2 groups. Group 1 will receive antiretroviral drugs alone for 24 weeks. Periodically throughout the study, patients in Group 1 will return to the clinic for a brief physical exam and blood tests. Group 2 will receive antiretroviral drugs continuously plus IL-2 at intervals. That is, patients in Group 2 will be given an injection of IL-2 every 12 hours for 5 days every 8 weeks for at least 24 weeks. Periodically throughout the study, Group 2 will have clinic visits which may include a physical exam, chest X-ray, blood and urine tests, and an ECG (records the activity of the heart). You may be eligible for this study if you: Are HIV-positive. Have a CD4 cell count greater than or equal to 300 cells/mm3. Have no AIDS-defining illnesses. Are at least 18. Have been on antiretroviral therapy for at least 7 days prior to study entry. You will not be eligible for this study if you: Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect your safety or ability to complete the study. Have a history of the following: cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease. Are pregnant or breast-feeding. Have ever received IL-2.

Study Type and Design: Treatment; Randomized Control Study

Official Title: A Randomized, Open-Label Phase II Study of Subcutaneous Interleukin-2 (Proleukin) Plus Antiretroviral Therapy vs. Antiretroviral Therapy Alone in Patients With HIV Infection and at Least 350 CD4+ Cells/mm3

Further Study Details: To evaluate the safety, tolerance, and immunological efficacy of subcutaneously administered interleukin-2 (IL-2) in combination with antiretroviral therapy, in HIV-infected patients with CD4 counts of 350 cells/mm3 or more.  IL-2, administered subcutaneously in combination with antiretrovirals, has resulted in increased CD4+ cell counts which may retard HIV disease progression. Using a smaller patient sampling, this Phase II study helps develop the clinical experience needed to consider formation of a larger, more complete Phase III trial.  Seventy-two HIV-infected patients (previously treated or naive) are randomized independently to receive either control therapy with antiretrovirals alone OR escalating doses of subcutaneous interleukin-2 (IL-2) plus antiretrovirals. In the absence of dose-limiting toxicity (DLT) in at least 9 of 12 patients in Group 1, 12 additional patients are entered into Group 2 and treated as indicated. In the absence of DLT in 9 of 12 patients in Group 2, the final 12 patients are entered into Group 3. Those patients enrolled in either of the first 2 dose groups who complete 3 courses of therapy have their dose escalated to a maximum dose. A course of treatment is defined as 5 days of IL-2 plus antiretrovirals followed by 7 weeks of antiretroviral therapy alone.  

Eligibility

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

Patients must have: 1. Asymptomatic, HIV-1 infection documented by positive ELISA and confirmatory test. 2. CD4+ cell count of 350 cells/mm3 or more within 30 days prior to start of study. 3. No AIDS-defining illness.

Required: Antiretroviral therapy for at least 7 days prior to drug administration.

Not breast-feeding

Abstinence or agree to use barrier methods of birth control / contraception during the study

Negative pregnancy test within 14 days of study entry

Bilirubin <= 2 x ULN ULN (Upper Limit of Normal). <= 5 x ULN allowed if due to benign conditions (e.g., Gilbert's disease) or use of indinavir therapy.

CD4 >= 350 cells/mm3

Creatinine <= 2 g/dl

Granulocytes >= 1000

Hemoglobin >= 11 g/dl

Karnofsky 80 to 100

Platelet Count >= 50000 /mm3 Within 30 days prior to start of treatment.

SGOT(AST) <= 4.9 x ULN

Exclusion Criteria

Patients with the following prior conditions are excluded: History of AIDS-defining illness, malignancy within the previous 5 years (except mucocutaneous Kaposi's sarcoma or local cutaneous malignancy not requiring systemic treatment), history of Crohn's disease, patients with any serious psychiatric, medical, and/or cognitive disturbances or illnesses, psoriasis or other autoimmune/inflammatory diseases that present life-threatening complications.

Patients with the following condition or symptoms are excluded: 1. Malignancy (other than mucocutaneous Kaposi's sarcoma) treated within the past 5 years. 2. CNS abnormality requiring medications. 3. Crohn's disease, psoriasis, or other autoimmune/inflammatory diseases with potentially life-threatening complications. 4. Serious psychiatric, medical, and/or cognitive disturbance or illness that may affect safety, compliance, or ability to provide informed written consent.

Excluded: 1. Prior IL-2 therapy. 2. Systemic corticosteroids, chemotherapy, or experimental cytotoxic drugs within 4 weeks prior to study entry.

Excluded: Use of approved or experimental agents with clinically significant immunomodulatory effects.

Excluded: Use of approved or experimental agents with clinically significant immunomodulatory effects.

Excluded: Occasional or habitual use of recreational drugs/alcohol that affects patient safety and/or compliance.

Location and Contact Information

Texas

Thomas Street Clinic, 2015 Thomas St    Houston,   Texas,   77009,   United States; Recruiting

Robert Arduino       713-793-4080   

Texas

Houston Clinical Research Network, 215 Westheimer Rd   Houston,   Texas,   77009,    United States; Recruiting

Joseph Gathe       713-526-9821   

Texas

OnCol Med Associates, 4140 Southwest Freeway   Houston,   Texas,   77027,   United States; No longer recruiting

Adan Rios       713-961-7100   

More Information

Study ID Numbers  SQIL-2;  IRP 021C; SQIL-2 Houston

NLM Identifier  NCT00000825

Recruitment status verified  April 8, 1999

Last Updated  April 13, 1999

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