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An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002172
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.

Condition Intervention
HIV Infections Biological: HIV-1 Immunogen

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • HIV-1 seropositivity.
  • CD4 counts < 300 cells/ml.

NOTE:

  • If a patient's CD4 count is 275 to 300 cells/ml, the patient must either rescreen for Study 806 or wait 6 months before entering the expanded access program.
  • Patient must have failed or been intolerant to other comparable or alternative marketed therapies or must not be a candidate for such therapies.
  • Patient must not meet inclusion criteria for other Remune trials.
  • Patient must have laboratory tests within specified limits.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Clinically significant cardiac, hepatic, renal, or gastrointestinal dysfunction.
  • Current participation in a Remune study.

Concurrent Medication:

Excluded:

  • Use of any immune-modulating drugs.
  • Induction therapy or initiation of new treatment regimen for an AIDS-defining condition.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

  • Use of any immune-modulating drugs within 3 months of Day 1 visit.
  • Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002172


Locations
United States, California
Immune Response Corp
Carlsbad, California, United States, 92008
Sponsors and Collaborators
The Immune Response Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00002172     History of Changes
Other Study ID Numbers: 093
901
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: June 1995

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS Vaccines
CD4 Lymphocyte Count
Salk HIV Immunogen

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases


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