Expired Study
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Carlsbad, California 92008


Purpose:

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


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.


NCT ID:

NCT00002172


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Carlsbad, California 92008
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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