Safety and Efficacy of the Therapeutic Vaccine GI-5005 Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone in Patients With Genotype 1 Chronic Hepatitis C Infection
Public ClinicalTrials.gov record NCT00606086. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Randomized, Open Label, Multi-center, Therapeutic Trial of the Efficacy, Immunogenicity, and Safety of GI-5005; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing a Hepatitis C Virus NS3-Core Fusion Protein, Combined With Pegylated Interferon Plus Ribavirin Standard of Care Therapy Versus Standard of Care Alone, and GI-5005 Salvage of Standard of Care Failures, in Patients With Genotype 1 Chronic Hepatitis C Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.
Study identification
- NCT ID
- NCT00606086
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2007 (Type not available)
- Primary completion
- Nov 2012 (Actual)
- Completion
- Nov 2012 (Actual)
- Last update posted
- Jun 27, 2014
2007 – 2012
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| Scripps Clinic Torrey Pines | La Jolla | California | 92037 | — |
| Research and Education inc. | San Diego | California | 92105 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | — |
| University of Connecticut Health Center | Farmingtom | Connecticut | 06030 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| NW Georgia Research Institute | Marietta | Georgia | 30060 | — |
| Hawaii Medical Center | Honolulu | Hawaii | 96817 | — |
| Northwest Indiana Center for Clinical Research | Valparaiso | Indiana | 46383 | — |
| Tulane University Hospital | New Orleans | Louisiana | — | — |
| Maryland Digestive Disease Research | Laurel | Maryland | 20707 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Gastroenterology Associates, PA | Jackson | Mississippi | 39202 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| Weill Medical College of Cornell University | New York | New York | 10021 | — |
| Columbia University | New York | New York | 10032 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Liver Institute of Virginia Bon Secours Health System | Newport News | Virginia | 23602 | — |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00606086, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 27, 2014 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00606086 live on ClinicalTrials.gov.