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Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
This study is ongoing, but not recruiting participants.
Study NCT00000821   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: November 2, 1999   Last Updated: July 30, 2008   History of Changes

November 2, 1999
July 30, 2008
 
 
 
 
Complete list of historical versions of study NCT00000821 on ClinicalTrials.gov Archive Site
 
 
 
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers.

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.

Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.

Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.

Phase I
Interventional
Treatment
HIV Infections
Drug: Aldesleukin
 
Davey RT Jr, Chaitt DG, Albert JM, Piscitelli SC, Kovacs JA, Walker RE, Falloon J, Polis MA, Metcalf JA, Masur H, Dewar R, Baseler M, Fyfe G, Giedlin MA, Lane HC. A randomized trial of high- versus low-dose subcutaneous interleukin-2 outpatient therapy for early human immunodeficiency virus type 1 infection. J Infect Dis. 1999 Apr;179(4):849-58.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
78
 
 

Inclusion Criteria

Patients must have:

  • HIV positivity.
  • CD4 count >= 500 cells/mm3.
  • No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma.

Concurrent Medication: Required:

  • Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T).

Prior Medication: Required:

  • FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Significant cardiac, pulmonary, thyroid, renal, or CNS disease.

Prior Medication:

Excluded:

  • Prior IL-2.
  • Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000821
 
IL-2 SC, IRP 015, 93-I-0205
National Institute of Allergy and Infectious Diseases (NIAID)
 
 
National Institute of Allergy and Infectious Diseases (NIAID)
August 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP