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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 - Article


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CD4


Clinical Trial: 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.

Sponsored by: Immune Response
Information provided by: 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 Treatment or Intervention
HIV Infections
 Vaccine: HIV-1 Immunogen

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Open Label

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Location Information


California
      Immune Response Corp, Carlsbad,  California,  92008,  United States

More Information

Study ID Numbers:  093; 901
Record last reviewed:  June 1995
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002172
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: June 1, 2005
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