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

Launched by THE IMMUNE RESPONSE CORPORATION · Aug 30, 2001

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.