We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002173
First Posted: August 31, 2001
Last Update Posted: June 24, 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
November 2, 1999
August 31, 2001
June 24, 2005
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.
An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.
To provide an alternative therapy to HIV-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.
Not Provided
Interventional
Not Provided
Primary Purpose: Treatment
HIV Infections
Biological: HIV-1 Immunogen
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

Inclusion Criteria

Patients must have:

  • HIV-1 seropositivity.
  • CD4 counts >= 550 cells/ml.

NOTE:

  • If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days 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.
  • Current participation in a Remune study.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

  • Previous participation in a Remune study.

Excluded within 30 days of study entry:

  • Use of any immune-modulating drugs.
  • Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002173
094
902
Not Provided
Not Provided
Not Provided
Not Provided
The Immune Response Corporation
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
June 1998

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP