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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002172
• Other study ID #: 093
• Secondary ID: 901
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1995
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• HIV-1 Immunogen

Locations

Country	Name	City	State
United States	Immune Response Corp	Carlsbad	California

Sponsors (1)

Lead Sponsor	Collaborator
The Immune Response Corporation

Country where clinical trial is conducted

United States,