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Sponsors and Collaborators: |
Merck HIV Vaccine Trials Network |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00095576 |
This study will test the safety and efficacy of an investigational HIV vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected.
Condition | Intervention | Phase |
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AIDS HIV Infections |
Biological: Comparator: V520 Drug: Comparator: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase II Proof-of-Concept Study to Evaluate the Safety and Efficacy of a 3-Dose Regimen of the V520 Vaccine in Adults at High Risk of HIV-1 Infection |
Estimated Enrollment: | 1500 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
V520
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Biological: Comparator: V520
V520 in three 1 mL IM doses at Day 1, Week 4, and Week 26.
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2: Placebo Comparator
Placebo
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Drug: Comparator: placebo
Placebo to V520 in three 1 mL IM doses at Day 1, Week 4, and Week 26.
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No further treatment is being given in V520-023, however patients are being followed. V520-023 protocol will end earlier than originally planned per protocol and participants (HIV infected and uninfected) will have the option of participating in an observational long term follow up protocol called V520-030/HVTN 504, which will serve as an extension of V520-023 and will continue through the end of 2009.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria: None
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2004_091, V520-023 |
Study First Received: | November 5, 2004 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00095576 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Lentivirus Infections Infection |