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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIV-1 Immunogen
Sponsored by
The Immune Response Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS Vaccines, CD4 Lymphocyte Count, Salk HIV Immunogen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Immune Response Corp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
The Immune Response Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00002173
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Immune Response Corporation

4. Oversight

5. Study Description

Brief Summary
To provide an alternative therapy to HIV-infected patients for whom there is no comparable or satisfactory alternative drug or therapy available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, AIDS Vaccines, CD4 Lymphocyte Count, Salk HIV Immunogen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HIV-1 Immunogen

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Immune Response Corp
City
Carlsbad
State/Province
California
ZIP/Postal Code
92008
Country
United States

12. IPD Sharing Statement

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

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