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

NCT00006441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2015-03-09

No results posted yet for this study

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

Interventions

DRUG

Lamivudine/Zidovudine

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.

DRUG

Nelfinavir mesylate

1250 mg twice daily for 104 weeks.

DRUG

Aldesleukin

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

Sponsors & Collaborators

  • Chiron Corporation

    collaborator INDUSTRY

  • Agouron Pharmaceuticals

    collaborator INDUSTRY

  • Glaxo Wellcome

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jay Levy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006441 on ClinicalTrials.gov