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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002172
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1995

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002172 on ClinicalTrials.gov Archive Site
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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
An Expanded Access Open-Label, Compassionate Use Protocol of Remune in HIV-1-Infected Adults With CD4 Count Less Than 300 Cells/Ml

To provide product through an expanded access program to HIV-infected patients with CD4 counts less than 300 cells/ml.

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Interventional
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Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Biological: HIV-1 Immunogen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002172
093, 901
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The Immune Response Corporation
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NIH AIDS Clinical Trials Information Service
June 1995

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