Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV

NCT00006441 | Completed

• 3 other identifiers: AI-01-001AIEDRP AI-01-00110435
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV). After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.

Conditions

HIV Infections

Keywords

Virus Replication; HIV-1; Interleukin-2; Drug Therapy, Combination; Zidovudine; HIV Protease Inhibitors; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Biological Markers; Lamivudine; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Nelfinavir; Cytotoxicity, Immunologic; Acute Infection

Outcome Measures

Primary Outcomes (4)

• To evaluate the dynamics of HIV in different tissue compartments of maximally suppressive antiretroviral (ART) medications with IL-2 influences, viral pathogenesis and immune responses to HIV infection.

  Throughout study

• To determine the patterns of immunologic activation as measured by cell surface marker levels, soluble and cell-associated cytokines when persons with acute or early HIV infection are treated with ART and IL-2.

  Throughout study

• To examine whether the extent of CD8+ cell antiviral activity as measured by non-cytotoxic and cytotoxic responses affects the kinetics of viral replication and viral load in blood plasma.

  Throughout study

• To determine whether a broad cellular immune response to HIV infection, measured by T cell repertoire, cytotoxic T cell lymphocyte function and CD4 T helper function correlates with the patterns of cellular immune antiviral responses

  Throughout study

Secondary Outcomes (1)

• To follow a cohort of HIV negative individuals that tested with the Options Project to use as a comparison group with the HIV positive individuals enrolling in this protocol.

  Throughout study

Study Arms (2)

A

EXPERIMENTAL

Patients beginning IL-2 treatment regimens after 4 weeks of study

Drug: Lamivudine/Zidovudine; Drug: Nelfinavir mesylate; Drug: Aldesleukin

B

ACTIVE COMPARATOR

Patients beginning IL-2 treatment after some delay based on specified criteria

Drug: Lamivudine/Zidovudine; Drug: Nelfinavir mesylate; Drug: Aldesleukin

Interventions

Lamivudine/Zidovudine DRUG

300/150 mg respectively twice daily for 104 weeks. Patients who develop intolerence to AZT may use Stavudine (d4T) at a dose of 40 mg daily.

Also known as: Combivir

A; B

Nelfinavir mesylate DRUG

1250 mg twice daily for 104 weeks.

Also known as: NFV

A; B

Aldesleukin DRUG

7.5 million units twice daily. Treatment will last until conclusion of study.

Also known as: IL-2

A; B

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:
• Have recent HIV infection.
• Are available for follow-up for at least 96 weeks.
• Are at least 18 years old.
• Use a barrier method of birth control.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Have a condition such as Epstein-Barr virus, CMV mononucleosis syndrome, or acute streptococcal pharyngitis.
• Have taken anti-HIV therapy for over 4 weeks.
• Have or have had cancer requiring chemotherapy or radiation therapy within 1 month of study entry and have not yet recovered from the effects.
• Abuse alcohol and other drugs.
• Are pregnant.
• Have a condition which interferes with intestinal absorption, such as severe diarrhea.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Chiron Corporation: collaborator
• Agouron Pharmaceuticals: collaborator
• Glaxo Wellcome: collaborator

Study Sites (2)

University of Alabama- Birmingham

Birmingham, Alabama, 35294, United States

Location

Rick Hecht

San Francisco, California, 941102859, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

lamivudine, zidovudine drug combination; Nelfinavir; aldesleukin; Interleukin-2

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

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Jay Levy

  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: November 3, 2000
• First Posted: August 31, 2001
• Study Start: February 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 9, 2015

Record last verified: 2014-04

Locations

US (2)