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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ClinicalTrials.gov Identifier: NCT00002173 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Biological: HIV-1 Immunogen | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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. |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002173
United States, California | |
Immune Response Corp | |
Carlsbad, California, United States, 92008 |
ClinicalTrials.gov Identifier: | NCT00002173 History of Changes |
Other Study ID Numbers: |
094 902 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 1998 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |