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| Sponsor: | Argos Therapeutics |
|---|---|
| Information provided by (Responsible Party): | Argos Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01069809 |
Purpose
The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the individuals are both taking antiretroviral therapy (ART) medication and interrupting ART medication.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection |
Biological: AGS-004 Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Phase 2B Study Testing the Efficacy and Safety of AGS-004 on Host Control of HIV Replication During Analytical Treatment Interruption |
| Estimated Enrollment: | 42 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AGS-004
HIV-1 Immune Therapy
|
Biological: AGS-004
HIV-1 Immune Therapy
|
|
Placebo Comparator: Inactive Injection
Inactive Placebo Injection
|
Biological: Placebo
Inactive Placebo Injection
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Evidence of hepatic decompensation in cirrhotic subjects: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, or screening laboratory results of any of the following:
Contacts and Locations| Contact: Esther Villiard | 919-287-9487 | evilliard@argostherapeutics.com |
| United States, California | |
| UCDavis Research Office at CARES | Recruiting |
| Sacramento, California, United States, 95811 | |
| Contact: Tammy Yotter 916-914-6261 tammy.yotter@ucdmc.ucdavis.edu | |
| Principal Investigator: David Asmuth, MD | |
| United States, New York | |
| Jacobi & North Central Bronx Hospitals | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Angelo Seda 718-918-3662 Angelo.Seda@nbhn.net | |
| Principal Investigator: David Stein, MD | |
| United States, North Carolina | |
| AIDS Clinical Trials Unit | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Contact: Susan Pedersen 919-966-6713 spederse@med.unc.edu | |
| Principal Investigator: David Margolis, MD | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Debbie McMullen 919-668-3759 mcmul006@mc.duke.edu | |
| Principal Investigator: Charles Hicks, MD | |
| United States, Pennsylvania | |
| Division of Infectious Disease and HIV Medicine Partnership Comprehensive Care Practice | Recruiting |
| Philadelphia, Pennsylvania, United States, 191002 | |
| Contact: Sharon Lewis 215-762-3251 Sharon.Lewis@DrexelMed.edu | |
| Principal Investigator: Jeff Jacobson, MD | |
| Canada, Ontario | |
| The Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada, K1H 816 | |
| Contact: Nancy Lamoureux (613) 737-8209 nlamoureux@ohri.ca | |
| Principal Investigator: Angel Jonathan, MD | |
| Canada, Quebec | |
| Clinique médicale l'Actuel | Recruiting |
| Montréal, Quebec, Canada, H2L4P9 | |
| Contact: Ioannis Vertzagias 514-524-3642 ext 239 ivertzagias@lactuel.ca | |
| Contact: Isabelle Benoit 514-524-3642 ext 222 ibenoit@lactuel.ca | |
| Principal Investigator: Sylvie Vezina, MD | |
| Clinique Médical du Quartier Latin | Recruiting |
| Montréal, Quebec, Canada, H2L5B1 | |
| Contact: Claude Gagne 514-285-1487 ext 225 info@quartier-latin.ca | |
| Principal Investigator: Jean-Guy Baril, MD | |
| Montreal Chest Institute, Immunodeficiency Dept. | Recruiting |
| Montréal, Quebec, Canada, H2X 2P4 | |
| Contact: Nathalie Morin 514-934-1934 ext 32537 nathalie.m.morin@muhc.mcgill.ca | |
| Principal Investigator: Jean-Pierre Routy, MD | |
| Principal Investigator: | Jeffery Jacobson, MD | Drexel University |
More Information
| Responsible Party: | Argos Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01069809 History of Changes |
| Other Study ID Numbers: | AGS-004-003, HHSN266200600019C, ES-11702 |
| Study First Received: | February 16, 2010 |
| Last Updated: | November 9, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |