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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 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: NCT00000889
  Purpose

To demonstrate the safety and tolerability of subcutaneously administered interleukin-2 (IL-2) plus antiretrovirals in patients with HIV infection and CD4 counts of 350 cells/mm3 or more. To demonstrate the immunological efficacy of subcutaneous IL-2 therapy plus antiretroviral therapy relative to antiretroviral therapy alone.

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.


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, Safety 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 as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   78
Study Completion Date:   August 2007

Detailed Description:

Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in increases in CD4+ cell count that might impact upon HIV disease progression. A Phase III trial involving large numbers of HIV-positive patients is the next step in the development process. To develop appropriate clinical experience with the combination, this Phase II trial will allow administration of IL-2 plus antiretroviral therapy to a small number of patients in sites being considered for the Phase III trial.

Patients are randomized to control therapy with antiretrovirals alone (36 patients) or antiretrovirals plus IL-2 given subcutaneously every 12 hours for 5 days every 8 weeks. Three doses of IL-2 are studied, with 12 patients evaluated at each dose.

If at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicities, the next 12 patients randomized are treated with the next higher dose; if this dose is tolerated, the last 12 patients randomized receive the highest study dose. Patients enrolled at the first two doses of IL-2 who complete three courses have their dose escalated to a maximum of the highest dose.

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

Criteria

Inclusion Criteria

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.
  • Are at least 18.
  • Have been on antiretroviral therapy for at least 7 days prior to study entry.

Exclusion Criteria

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 cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system (CNS) abnormality, or an autoimmune/inflammatory disease.
  • Are pregnant or breast-feeding.
  • Have ever received IL-2.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000889

Locations
Argentina
FUNCEI    
      Buenos Aires, Argentina
Hosp Muniz    
      Buenos Aires, Argentina
Hosp Fernandez    
      Buenos Aires, Argentina
Hosp Ramos Mejias    
      Buenos Aires, Argentina
Hosp de Clinicas    
      Buenos Aires, Argentina
Hosp Italiano    
      Buenos Aires, Argentina

Sponsors and Collaborators

Investigators
Study Chair:     M Losso    
  More Information


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

Study ID Numbers:   SQ 1 ARG, IRP 021A, SQIL-2 Argentina
First Received:   November 2, 1999
Last Updated:   September 26, 2008
ClinicalTrials.gov Identifier:   NCT00000889
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Interleukin-2  
CD4 Lymphocyte Count  
Anti-HIV Agents  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Aldesleukin
HIV Seropositivity
Interleukin-2
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
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 December 03, 2008




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