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

The Immune Response Corporation2 个研究点分布在 1 个国家开始时间: 2001年8月31日最近更新: 2005年6月24日

适应症

试验速览

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

•Patients must have:
•HIV-1 seropositivity.
•CD4 counts < 300 cells/ml.
•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.

•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:
•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:
•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.

发起方

The Immune Response Corporation

申办方类型

Industry

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