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AzTrials

HIV InfectionsPhase 3NCT00002359

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

A Phase 3 study testing HIV-1 Immunogen in people with HIV Infections, run by The Immune Response Corporation at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
HIV-1 Immunogen
How many people
3,000 participants
Where
54 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Infectious Disease Physicians Inc

    Annandale, Virginia, 22003

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • JSI Research and Training Institute

    Boston, Massachusetts, 02210

  • Community Research Initiative of New England

    Brookline Village, Massachusetts, 02445

  • Med Univ of South Carolina

    Charleston, South Carolina, 29425

  • Nalle Clinic

    Charlotte, North Carolina, 28207

  • Rush Med Ctr

    Chicago, Illinois, 60612

  • Chicago AIDS Research Alliance

    Chicago, Illinois, 60657

  • Ctr for Special Immunology

    Chicago, Illinois, 60657

  • Univ of Cincinnati Med Ctr / Holmes Division

    Cincinnati, Ohio, 45267

  • Ohio State Univ / Division of Infectious Disease

    Columbus, Ohio, 43210

  • Metroplex Clinical Research Ctr

    Dallas, Texas, 75235

  • Wayne State Univ / WSU / DMC HIV / AIDS Program

    Detroit, Michigan, 48201

  • Henry Ford Hosp / Infectious Diseases

    Detroit, Michigan, 48202

  • North Broward Hosp District

    Fort Lauderdale, Florida, 33316

  • Univ of Texas Med Branch Ctr for Clinical Studies

    Galveston, Texas, 77555

  • Hampton Roads Med Specialists

    Hampton, Virginia, 23666

  • Providence Mercy Hosp

    Holyoke, Massachusetts, 01040

  • ONCOL Med Associates / PA

    Houston, Texas, 77027

  • Community Hosp Indianapolis

    Indianapolis, Indiana, 46219

  • Ctr for Special Immunology

    Irvine, California, 92718

  • Kansas City AIDS Research Consortium

    Kansas City, Missouri, 64111

  • Univ of Kentucky / Division of ID Research

    Lexington, Kentucky, 40536

  • Jeffrey Goodman Special Care Clinic

    Los Angeles, California, 90028

  • Kraus Med Partners

    Los Angeles, California, 90036

  • Cedars Sinai Med Ctr

    Los Angeles, California, 90048

  • Ctr for Special Immunology

    Miami Beach, Florida, 33140

  • Wisconsin AIDS Research Consortium

    Milwaukee, Wisconsin, 53203

  • Abbott Northwestern Hosp

    Minneapolis, Minnesota, 55407

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 37212

  • Anderson Clinical Research

    New York, New York, 10016

  • St Luke's - Roosevelt Hosp Ctr / Div of Infect Dis

    New York, New York, 10019

  • Cornell Univ Med College

    New York, New York, 10021

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Dr Barbara Justice

    New York, New York, 10031

  • Eastern Virginia Med School

    Norfolk, Virginia, 23507

  • The Coleman Institute

    North Miami, Florida, 33179

  • Univ of Oklahoma

    Oklahoma City, Oklahoma, 73117

  • Mem Hosp of Rhode Island

    Pawtucket, Rhode Island, 02860

  • The Graduate Hosp

    Philadelphia, Pennsylvania, 19146

  • Phoenix Body Positive

    Phoenix, Arizona, 85016

  • Anderson Clinical Research

    Pittsburgh, Pennsylvania, 15218

  • The Research and Education Group

    Portland, Oregon, 97210

  • AIDS Community Research Consortium

    Redwood City, California, 94063

  • Community Health Network

    Rochester, New York, 14620

  • Univ of Utah Med School / Clinical Trials Ctr

    Salt Lake City, Utah, 84108

  • Novum Inc

    Seattle, Washington, 98104

  • Washington Univ / St Louis Connect Care

    St Louis, Missouri, 63108

  • Clinical Pharmacology Services

    Tampa, Florida, 33617

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10456

  • Whitman Walker Clinic Inc

    Washington D.C., District of Columbia, 20009

  • Anderson Clinical Research

    Washington D.C., District of Columbia, 20037

  • George Washington Univ Med Ctr

    Washington D.C., District of Columbia, 20037

  • UKSM-W Med Practice Association

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV Infections
Being tested
HIV-1 Immunogen
Keywords
Vaccines, Synthetic, Viral Vaccines, HIV-1, AIDS-Related Complex, AIDS Vaccines, Salk HIV Immunogen
Medical subject headings
HIV Infections, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV-1 ImmunogenBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Masking
Double blind
Enrolment
3,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002359
Sponsor's protocol ID
092
Other IDs
806
Status last verified
Jun 1997
First submitted
2 Nov 1999
Last updated
24 Jun 2005
Results posted
No

Publications

  • Kahn JO, Cherng DW, Mayer K, Murray H, Lagakos S. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10(6)/L CD4 cell counts: A randomized controlled trial. JAMA. 2000 Nov 1;284(17):2193-202. doi: 10.1001/jama.284.17.2193.

    PubMed 11056590

  • Rao MP, Al-Khatib SM, Pokorney SD, She L, Romanov A, Nicolau JC, Lee KL, Carson P, Selzman CH, Stepinska J, Cleland JG, Tungsubutra W, Desvigne-Nickens PM, Sueta CA, Siepe M, Lang I, Feldman AM, Yii M, Rouleau JL, Velazquez EJ; STICH Trial Investigators. Sudden Cardiac Death in Patients With Ischemic Heart Failure Undergoing Coronary Artery Bypass Grafting: Results From the STICH Randomized Clinical Trial (Surgical Treatment for Ischemic Heart Failure). Circulation. 2017 Mar 21;135(12):1136-1144. doi: 10.1161/CIRCULATIONAHA.116.026075. Epub 2017 Feb 2.

    PubMed 28154006

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HIV-1 Immunogen in people with HIV Infections, run by The Immune Response Corporation at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002359, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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