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

NCT00000948 | Completed Phase 2

• 3 other identifiers: IRP 021B10465THAILAND
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (2)

• CD4 count

  Throughout study

• Laboratory and clinical adverse events

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

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.

Drug: Aldesleukin; Drug: ART

2

ACTIVE COMPARATOR

All participants will receive ART

Drug: ART

Interventions

Aldesleukin DRUG

Il-2

1

ART DRUG

antiretroviral therapy for the treatment of HIV

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Chulalongkorn Univ. Hosp. C603-010 CRS

Bangkok, Ratchathewi, Thailand

Location

Siriraj Hospital C603-020 CRS

Bangkok, Ratchathewi, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Kiat Ruxrungthum

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: February 1, 1998
• Primary Completion: March 1, 2000
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

TH (2)