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


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Aldesleukin

IL-2; Interleukin-2; Proleukin; r-serHuIL


Clinical Trial: Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected with HIV

This study has been completed.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Chiron Corporation
Agouron Pharmaceuticals
Glaxo Wellcome
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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.

Condition Treatment or Intervention
HIV Infections
 Drug: Lamivudine/Zidovudine
 Drug: Nelfinavir mesylate
 Drug: Aldesleukin

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label, Efficacy Study

Official Title: A Single Center, Randomized Open Label Study of Initial Interleukin-2 Compared to Delayed Interleukin-2 When Added to Zidovudine, 3TC and Nelfinavir In Order to Modulate Immune Function and to Sustain Suppression of HIV-1 Replication Among Those Persons with Primary or Early HIV Infection

Further Study Details: 

Expected Total Enrollment:  120

Following initial exposure to HIV, infection is established through the rapid replication of a homogeneous strain of the virus. Preliminary studies of combination antiretroviral therapy show that it is possible to reduce circulating HIV RNA to below detectable levels at this phase. Sustained suppression of viral replication or viral eradication may be possible only before HIV has become integrated in the immune system and undergone a number of quasi species mutations. This study will assess the feasibility of interrupting the natural course of HIV infection by using antiretroviral therapy soon after initial infection.

Nelfinavir (NFV) and zidovudine/lamivudine (Combivir) treatment starts as soon as possible and at most, 7 days from the diagnosis of HIV infection, and continues for 104 weeks. After 4 weeks of therapy patients are randomized to begin receiving IL-2 therapy or to delay starting it until Week 48. Patients may choose not to receive IL-2 treatment and remain in the study. Patients have clinic visits to measure viral load every 4 weeks. At a final clinic visit, physical examinations and collection of semen, cervical fluid, blood, and saliva specimens are done. Eligible consenting patients have a tonsil biopsy. Patients are reimbursed for participation in this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

Location Information


Alabama
      University of Alabama- Birmingham, Birmingham,  Alabama,  35294,  United States

California
      Rick Hecht, San Francisco,  California,  941102859,  United States

Study chairs or principal investigators

Jay Levy,  Principal Investigator

More Information

Click here for more information about aldesleukin

Click here for more information about nelfinavir mesylate

Click here for more information about lamivudine/zidovudine

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

Study ID Numbers:  AIEDRP AI-01-001
Record last reviewed:  March 2005
Last Updated:  April 7, 2005
Record first received:  November 3, 2000
ClinicalTrials.gov Identifier:  NCT00006441
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 11, 2008



Page Updated: June 1, 2005
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