Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients

NCT00001131 | Completed

• 2 other identifiers: AI-06-001AIEDRP AI-06-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if the immune systems of HIV-positive patients can be improved by treatment with anti-HIV medications plus interleukin-2 (IL-2) in the early stages of HIV infection. IL-2 is a protein found naturally in the blood that can help boost the immune system. HIV spreads throughout the body by invading CD4 cells, which are cells of the immune system that fight infection. Doctors hope that adding IL-2 to a current anti-HIV drug combination can help restore the CD4 cell count and the immune functions. This study will look at how the HIV virus acts during the early stages of HIV infection, how the immune system responds to HIV, and what impact early treatment with anti-HIV medications has on the course of HIV infection.

Conditions

HIV Infections

Keywords

Interleukin-2; Drug Therapy, Combination; Drug Administration Schedule; Viremia; T-Lymphocytes, Cytotoxic; Anti-HIV Agents; Treatment Experienced

Outcome Measures

Primary Outcomes (3)

• Augmentation and extention of HTL response

  Throughout study

• Reduction in extent of damage and acceleration of immune system recovery

  Throughout study

• Delay of and reduction in recurrent viremia compared to historical controls

  Throughout study

Study Arms (2)

A

EXPERIMENTAL

Patients will recieve a daily, self-administered subcutaneous injection of IL-2 while continuing treatment with their current oral anti-HIV medications

Drug: Aldesleukin; Drug: HAART

B

ACTIVE COMPARATOR

Patients will only follow their current oral anti-HIV medication regimen. No additional IL-2 injection will be given.

Drug: HAART

Interventions

Aldesleukin DRUG

Subcutaneous injection of IL-2 in the amount of 2.0 X 10\^6 mIU per day for the entire duration of therapy

Also known as: Chiron IL-2

A

HAART DRUG

Current HAART regimen to be continued for duration of therapy or until certain criteria specified by the study is met

A; B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• HIV-infected.
• Viral load of 5,000 copies/ml or less within 3 months.
• Completed at least 3 months of anti-HIV medications.
• Have a refrigerator to store the needles for IL-2 shots.

You may not qualify if:

• Glucocorticoids or other drugs that affect the immune system such as INF-alpha, G-CSF, or GM-CSF.

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Hosp

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

HIV Infections; Viremia

Interventions

aldesleukin; Antiretroviral Therapy, Highly Active

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; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• Joseph B Margolick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2000
• First Posted: August 31, 2001
• Study Start: May 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 15, 2015

Record last verified: 2013-09

Locations

US (1)