Trial | NCT00002173  Report issue

Official Title

An Expanded Access Open Label Protocol of Remune (HIV-1 Immunogen) in HIV-1-Infected Adults With CD4 Count 550 Cells /Ml and Greater.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
To provide an alternative therapy to HIV-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.
Study Started
Nov 02
1999
Last Update
Jun 24
2005
Estimate

Biological HIV-1 Immunogen

Criteria 

Inclusion Criteria

Patients must have:

HIV-1 seropositivity.
CD4 counts >= 550 cells/ml.

NOTE:

If a patient's CD4 count is 550 to 600 cells/ml, the patient must either rescreen within 30 days 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.
Current participation in a Remune study.

Patients with any of the following prior conditions are excluded:

Previous participation in a Remune study.

Prior Medication:

Excluded:

Previous participation in a Remune study.

Excluded within 30 days of study entry:

Use of any immune-modulating drugs.
Induction therapy or initiation of new treatment regimen for an AIDS-defining condition within 30 days of Day 1 visit.
No Results Posted