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Sponsored by: |
The Immune Response Corporation |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002359 |
To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: HIV-1 Immunogen |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Regardless of Concomitant HIV Therapies |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Study ID Numbers: | 092, 806 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002359 |
Health Authority: | United States: Food and Drug Administration |
Vaccines, Synthetic Viral Vaccines HIV-1 |
AIDS-Related Complex AIDS Vaccines Salk HIV Immunogen |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Freund's Adjuvant AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases |
Physiological Effects of Drugs Adjuvants, Immunologic Lentivirus Infections Infection Pharmacologic Actions |