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OpenTrials
Completed

NCT Number: NCT00002173

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

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

Completed

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIV-1 Immunogen

Biological

Sponsors and collaborators

Lead sponsor

The Immune Response Corporation

Industry

Registry information

Important dates

First posted
Aug 31, 2001
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.