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

NCT00002172 | Completed

• 2 other identifiers: 093901
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome; AIDS Vaccines; CD4 Lymphocyte Count; Salk HIV Immunogen

Interventions

HIV-1 Immunogen BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 have laboratory tests within specified limits.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Immune Response Corporation: lead

Study Sites (1)

Immune Response Corp

Carlsbad, California, 92008, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

HIV-1 immunogen, incomplete Freund's adjuvant

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1995-06

Locations

US (1)