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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000825
• Other study ID #: IRP 021C
• Secondary ID: 10466SQIL-2SQIL-
• Status: Completed
• Phase: Phase 2
• Start date: May 1998

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of giving IL-2 plus anti-HIV (antiretroviral) therapy to HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) of at least 350 cells/mm3. This study will also examine the ability of antiretroviral therapy combined with IL-2 to boost the immune system.

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.

Description:

IL-2, administered subcutaneously in combination with antiretrovirals, has resulted in increased CD4+ cell counts which may retard HIV disease progression. Using a smaller patient sampling, this Phase II study helps develop the clinical experience needed to consider formation of a larger, more complete Phase III trial.

Seventy-two HIV-infected patients (previously treated or naive) are randomized independently to receive either control therapy with antiretrovirals alone OR escalating doses of subcutaneous interleukin-2 (IL-2) plus antiretrovirals. In the absence of dose-limiting toxicity (DLT) in at least 9 of 12 patients in Group 1, 12 additional patients are entered into Group 2 and treated as indicated. In the absence of DLT in 9 of 12 patients in Group 2, the final 12 patients are entered into Group 3. Those patients enrolled in either of the first 2 dose groups who complete 3 courses of therapy have their dose escalated to a maximum dose. A course of treatment is defined as 5 days of IL-2 plus antiretrovirals followed by 7 weeks of antiretroviral therapy alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have a CD4 cell count greater than or equal to 300 cells/mm3.

• Have no AIDS-defining illnesses.

• Are at least 18 years old.

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

Exclusion Criteria

Patients will not be eligible for this study if they:

• Abuse alcohol or drugs, or have any serious psychiatric or medical illnesses that would affect their safety or ability to complete the study.

• Have a history of the following: cancer (other than Kaposi's sarcoma), an AIDS-defining illness, a central nervous system abnormality, or an autoimmune/inflammatory disease.

• Are pregnant or breast-feeding.

• Have ever received IL-2.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

Intervention

Drug:
• Aldesleukin

Locations

Country	Name	City	State
United States	Thomas Street Clinic C605-020 CRS	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

External Links

•   Haga clic aquí para ver información sobre este ensayo clínico en español.