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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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HIV-1 Immunogen

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Immune Response Corp

Carlsbad, California, United States

Site Status

Countries

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United States

Other Identifiers

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902

Identifier Type: -

Identifier Source: secondary_id

094