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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
This study has been completed.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000820
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Aldesleukin
Phase II

MedlinePlus related topics: AIDS
Drug Information available for: Aldesleukin Interleukin-2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
Official Title: 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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 104
Detailed Description:

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 randomized initially to receive their own antiretroviral therapy alone or in combination with IL-2 for 24 weeks, after which each group is crossed over to the other treatment assignment (i.e., IL-2 is either added or deleted from the regimen) for an additional 24 weeks. Patients who are vaccine eligible receive influenza, tetanus and diphtheria toxoid, and meningococcal polysaccharide vaccines at week 4, and those who have not received pneumococcal vaccine prior to study entry will receive it at week 8.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000820

Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Connecticut
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
United States, District of Columbia
George Washington Univ / Hershey Med Ctr
Washington, District of Columbia, United States, 20037
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Louisiana
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, New York
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Cornell Univ Med Ctr
New York, New York, United States, 10021
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Beth Israel Med Ctr
New York, New York, United States, 10003
United States, North Carolina
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 191075098
United States, Texas
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Sponsors and Collaborators
Investigators
Study Chair: Teppler H
Study Chair: Pomerantz R
  More Information

Click here for more information about aldesleukin  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: ACTG 248
Study First Received: November 2, 1999
Last Updated: July 28, 2008
ClinicalTrials.gov Identifier: NCT00000820  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interleukin-2
Drug Therapy, Combination
AIDS-Related Complex
Antiviral Agents

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Aldesleukin
Interleukin-2
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Antiviral Agents
Pharmacologic Actions
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009