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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002173
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1998
  Purpose

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


Condition Intervention
HIV Infections
Biological: HIV-1 Immunogen

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002173

Locations
United States, California
Immune Response Corp
Carlsbad, California, United States, 92008
Sponsors and Collaborators
The Immune Response Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002173     History of Changes
Other Study ID Numbers: 094, 902
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS Vaccines
CD4 Lymphocyte Count
Salk HIV Immunogen

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 26, 2014