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Sponsors and Collaborators: |
Epimmune Pharmexa A/S Pharmexa-Epimmune |
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Information provided by: | Epimmune |
ClinicalTrials.gov Identifier: | NCT00532974 |
The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: EP1090 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART) |
Estimated Enrollment: | 32 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | April 2008 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
AIDS Research Alliance | |
West Hollywood, California, United States, 90069 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80262 |
Study ID Numbers: | EP-HIV-1090 |
Study First Received: | September 19, 2007 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00532974 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Human Immunodeficiency Virus Vaccines HIV Vaccines |
Peptide Peptide Vaccines HIV 1 |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |