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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Patients are ran...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.
• • Immune globulin ( IVIG ).
• • Thalidomide.
• • Systemic corticosteroids (permitted for 21 days or less for PCP treatment only).
• Concurrent Treatment:
• Excluded:
• • Ongoing transfusion.
• Patients with the following prior conditions are excluded:
• • History of autoimmune disease, including inflammatory bowel disease and psoriasis (although autoimmune thyroid disease that is stable is allowed).
• • Clinically significant CNS disease or seizures that have been active within 1 year prior to study entry.
• Prior Medication:
• Excluded:
• • IL-2 within 3 months prior to study entry.
• • Any immunomodulatory therapy within 4 weeks prior to study entry.
• • Foscarnet within 4 weeks prior to study entry.
• • Acute therapy for an opportunistic infection within 14 days prior to study entry.
• • Active alcohol or substance abuse that would compromise study compliance.

Trial Officials