Back to resultsSubcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aldesleukin
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Interleukin-2, AIDS-Related Complex
Eligibility Criteria
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.
Sites / Locations
- Natl Inst of Allergy & Infect Dis / Cln Ctr
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000821
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00000821
Brief Title
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
Official Title
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Interleukin-2, AIDS-Related Complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
78 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aldesleukin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Natl Inst of Allergy & Infect Dis / Cln Ctr
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Giedlin M, McGrath M, Gascon R, DeGroat S, Fyfe G, Kahn J. Immunological characterization of HIV seropositive patients treated with subcutaneous Proleukin (aldesleukin) recombinant Interleukin-2. Int Conf AIDS. 1996 Jul 7-12;11(2):282 (abstract no ThB4183)
Results Reference
background
PubMed Identifier
10068580
Citation
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. doi: 10.1086/314678.
Results Reference
background
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Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients
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