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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000889

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Aldesleukin	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 1997

Actual Primary Completion Date :

Dec 1, 1999

Actual Study Completion Date :

Dec 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Hospital de Clinicas 'Jose de San Martin' C601-040 CRS	Ciudad de Buenos Aires	Buenos Aires	Argentina
2	Hospital F.J. Muniz C601-050 CRS	Ciudad de Buenos Aires	Buenos Aires	Argentina
3	Hospital General de Agudos J.M. Ramos Mejia CPCRA CRS	Ciudad de Buenos Aires	Buenos Aires	Argentina
4	Hospital Italiano de Buenos Aires C601-020 CRS	Ciudad de Buenos Aires	Buenos Aires	Argentina