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

NCT ID: NCT00000948

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-02-28

Brief 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.

Detailed Description

Interleukin-2 administered subcutaneously, in combination with antiretrovirals, results in an increased 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 this 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 receive antiretrovirals alone or antiretrovirals plus IL-2 given subcutaneously. Three doses of IL-2 are studied, with 12 patients evaluated at each dose. When at least 9 of the first 12 patients complete the 5-day dosing period without dose-limiting toxicity, the next 12 patients are treated at the next highest dose every 12 hours for 5 days every 8 weeks; when this dose is tolerated, the last 12 patients randomized receive the highest study dose every 12 hours for 5 days every 8 weeks. Patients enrolled at the first two doses of IL-2 who complete three courses of treatment have their dose escalated to a maximum of the highest study dose.

Conditions

HIV Infections

Keywords

Injections, Subcutaneous; Interleukin-2; Dose-Response Relationship, Drug; Drug Therapy, Combination; CD4 Lymphocyte Count; Anti-HIV Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will be broken into 3 groups. Each group will receive ART and escalating doses of aldesleukin. All participants will then receive that maximum tolerated dose of aldesleukin.

Group Type: EXPERIMENTAL

Aldesleukin

Intervention Type: DRUG

Il-2

ART

Intervention Type: DRUG

antiretroviral therapy for the treatment of HIV

2

All participants will receive ART

Group Type: ACTIVE_COMPARATOR

ART

Intervention Type: DRUG

antiretroviral therapy for the treatment of HIV

Interventions

Aldesleukin

Il-2

Intervention Type: DRUG

ART

antiretroviral therapy for the treatment of HIV

Intervention Type: DRUG

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiat Ruxrungthum

Role: STUDY_CHAIR

Locations

Chulalongkorn Univ. Hosp. C603-010 CRS

Bangkok, Ratchathewi, Thailand

Siriraj Hospital C603-020 CRS

Bangkok, Ratchathewi, Thailand

Countries

Thailand

Other Identifiers

10465

Identifier Type: REGISTRY

Identifier Source: secondary_id

THAILAND

Identifier Type: -

Identifier Source: secondary_id

IRP 021B

Identifier Type: -

Identifier Source: org_study_id