A Phase II Study of Low-Dose Interleukin-2 by Subcutaneous Injection in Combination With Antiretroviral Therapy Versus Antiretroviral Therapy Alone in Patients With HIV-1 Infection and at Least 3 Months Stable Antiretroviral Therapy

Completed · Phase 2

Conditions studied: HIV Infections

In brief

PRIMARY: To examine the effect of aldesleukin ( IL-2 ) on viral activity in the blood. To determine the safety of low-dose IL-2 in combination with antiretroviral therapy versus antiretroviral therapy alone. SECONDARY: To examine delayed type hypersensitivity responses to skin test antigens and antibody responses to protein and polysaccharide vaccines. The profound immune impairment that results from HIV-1 infection is due, at least in part, to the loss of CD4+ T cells and the cytokines these cells secrete, especially IL-2 and interferon-gamma. Antiretroviral agents do not directly address the problem of immune impairment. Replacement of IL-2 at nontoxic doses may prevent or delay clinical immunosuppression and its attendant opportunistic infections. Also, since patients with HIV-1 infection respond suboptimally to routine protein and polysaccharide immunizations, IL-2 may provide an adjuvant effect on vaccine responses.

Key facts

Study ID

NCT00000820

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

104

Expected to finish

2002-03-01

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• PCP prophylaxis.
• Therapy for an opportunistic infection that develops on study, with the exception of foscarnet for CMV disease or resistant Herpes simplex.
• Systemic corticosteroids ONLY IF given for no longer than 21 days for acute PCP.
• Topical corticosteroids to areas separate from a skin test or IL-2 injection site.
• Acyclovir up to 1000 mg/day as maintenance for recurrent genital Herpes.
• Erythropoietin and filgrastim.
• Antiemetics.
• Antibiotics as clinically indicated.
• Elective standard immunizations at week 8 or later.
• Concurrent Treatment:
• Allowed:
• Local radiation therapy.
• Prior Medication: Required:
• Stable, approved antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry.
• Patients must have:
• HIV seropositivity.
• CD4 count 300 - 700 cells/mm3.
• Stable antiretroviral therapy for at least 2 months (was 3 months, amended 3/26/96) prior to study entry.
• No history of AIDS-defining illness except for limited cutaneous Kaposi's sarcoma.
• Normal EKG (isolated nonspecific ST and T wave changes permitted).
• NOTE:
• This protocol is approved for prisoner participation.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Malignancy requiring systemic or local cytotoxic chemotherapy.
• Untreated thyroid disease.
• Asthma requiring intermittent or chronic inhalation or systemic therapy.
• Any medical condition that precludes study entry.
• Concurrent Medication:
• Excluded:
• Antianginal agents such as nitrates, calcium channel blockers, beta blockers, and antiarrhythmics.
• Systemic or local cytotoxic chemotherapy.
• Interferons.
• Interleukins other than study drug.
• Pentoxifylline ( Trental ).
• Acetylcysteine ( NAC ).
• Sargramostim ( GM-CSF ).
• Dinitrochlorobenzene ( DCNB ).
• Thymosin alpha 1.
• Thymopentin.
• Inosiplex ( Isoprinosine ).
• Polyribonucleoside ( Ampligen ).
• Ditiocarb sodium ( Imuthiol ).
• Therapeutic HIV vaccines.
• Investigational antiretroviral agents such as lamivudine ( 3TC ) and tat and protease inhibitors.
• Foscarnet.
• Aspirin.

Where it is running

• Alabama Therapeutics CRS — Birmingham, Alabama, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
• SUNY - Buffalo, Erie County Medical Ctr. — Buffalo, New York, United States
• Beth Israel Med. Ctr. (Mt. Sinai) — New York, New York, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Cornell University A2201 — New York, New York, United States
• Unc Aids Crs — Chapel Hill, North Carolina, United States
• Case CRS — Cleveland, Ohio, United States
• Hosp. of the Univ. of Pennsylvania CRS — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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