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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000820
First Posted: August 31, 2001
Last Update Posted: April 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  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 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Estimated Enrollment: 104
Study Completion Date: March 2002
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000820


Locations
United States, Alabama
Alabama Therapeutics CRS
Birmingham, Alabama, United States, 35294
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80262
United States, Indiana
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States, 462025250
United States, New York
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, United States, 14215
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States, 10003
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Cornell University A2201
New York, New York, United States, 10021
United States, North Carolina
Unc Aids Crs
Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Case CRS
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Teppler H
Study Chair: Pomerantz R
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000820     History of Changes
Other Study ID Numbers: ACTG 248
11225 ( Registry Identifier: DAIDS ES Registry ID )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: April 26, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Aldesleukin
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents