A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega

June 23, 2005 updated by: The Immune Response Corporation

A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Regardless of Concomitant HIV Therapies

To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.

Study Type

Interventional

Enrollment

3000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Body Positive
    • California
      • Irvine, California, United States, 92718
        • Ctr for Special Immunology
      • Los Angeles, California, United States, 90028
        • Jeffrey Goodman Special Care Clinic
      • Los Angeles, California, United States, 90036
        • Kraus Med Partners
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Med Ctr
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20037
        • Anderson Clinical Research
      • Washington, District of Columbia, United States, 20009
        • Whitman Walker Clinic Inc
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • North Broward Hosp District
      • Miami Beach, Florida, United States, 33140
        • Ctr for Special Immunology
      • North Miami, Florida, United States, 33179
        • The Coleman Institute
      • Tampa, Florida, United States, 33617
        • Clinical Pharmacology Services
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Ctr for Special Immunology
      • Chicago, Illinois, United States, 60612
        • Rush Med Ctr
      • Chicago, Illinois, United States, 60657
        • Chicago AIDS Research Alliance
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Community Hosp Indianapolis
    • Kansas
      • Wichita, Kansas, United States, 67214
        • UKSM-W Med Practice Association
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky / Division of ID Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02210
        • JSI Research and Training Institute
      • Brookline Village, Massachusetts, United States, 02445
        • Community Research Initiative of New England
      • Holyoke, Massachusetts, United States, 01040
        • Providence Mercy Hosp
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State Univ / WSU / DMC HIV / AIDS Program
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp / Infectious Diseases
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hosp
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City AIDS Research Consortium
      • Saint Louis, Missouri, United States, 63108
        • Washington Univ / St Louis Connect Care
    • New York
      • Bronx, New York, United States, 10456
        • Bronx Lebanon Hosp Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med College
      • New York, New York, United States, 10016
        • Anderson Clinical Research
      • New York, New York, United States, 10031
        • Dr Barbara Justice
      • New York, New York, United States, 10019
        • St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis
      • Rochester, New York, United States, 14620
        • Community Health Network
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Nalle Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Univ of Cincinnati Med Ctr / Holmes Division
      • Columbus, Ohio, United States, 43210
        • Ohio State Univ / Division of Infectious Disease
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Univ of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • The Graduate Hosp
      • Pittsburgh, Pennsylvania, United States, 15218
        • Anderson Clinical Research
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Mem Hosp of Rhode Island
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med Univ of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75235
        • Metroplex Clinical Research Ctr
      • Galveston, Texas, United States, 77555
        • Univ of Texas Med Branch Ctr for Clinical Studies
      • Houston, Texas, United States, 77027
        • ONCOL Med Associates / PA
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Univ of Utah Med School / Clinical Trials Ctr
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Infectious Disease Physicians Inc
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Med School
    • Washington
      • Seattle, Washington, United States, 98104
        • Novum Inc
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53203
        • Wisconsin AIDS Research Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretrovirals if on a stable dose for at least the past 3 months.

Patients must have:

  • HIV-1 infection with CD4 count 300-549 cells/mm3.
  • No AIDS-defining condition.
  • Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals.

NOTE:

  • KS is permitted if not requiring systemic therapy.

Prior Medication:

Allowed:

  • Prior antiretrovirals.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Systemic chemotherapy for KS.
  • Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Patients with the following prior conditions are excluded:

  • History of any illness that would interfere with study.
  • Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis.

Prior Medication:

Excluded:

  • Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Immune Response Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 092
  • 806

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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