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:
The Immune Response Corporation
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 May 19, 2013