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Sponsored by: |
Avexa |
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Information provided by: | Avexa |
ClinicalTrials.gov Identifier: | NCT00334659 |
The purpose of this study is to confirm that apricitabine does not induce any clinically significant effect upon electrocardiogram (ECG) parameters at doses consistent with the maximum exposure expected to occur in clinical practice.
Condition | Intervention | Phase |
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HIV Infections |
Drug: apricitabine |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Active Control, Crossover Assignment, Safety Study |
Official Title: | A Double-Blind, Placebo-Controlled, Positive Controlled, Randomized, Crossover Study to Investigate the Cardiovascular Safety of Apricitabine in Healthy Subjects |
Estimated Enrollment: | 48 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | August 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | AVX-101 |
Study First Received: | June 6, 2006 |
Last Updated: | January 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00334659 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Infection |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy 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 |