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 Corporation

Status: Completed

Conditions: HIV Infections

Treatments: Biological: HIV-1 Immunogen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002172

093

901

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.