Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals
NCT ID: NCT00393276
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2007-08-31
2009-07-31
Brief Summary
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Detailed Description
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This study will last approximately 24 weeks. Participants will be stratified to one of three arms, based on their HCV and HIV status:
* Arm A will enroll HCV-infected individuals who are HIV-uninfected
* Arm B will enroll HIV-infected individuals who are HCV-uninfected
* Arm C will enroll HCV/HIV-coinfected individuals
Arms B and C will open for enrollment before Arm A. Opening of enrollment for Arm A will be determined by the accrual progress of Arms B and C as evaluated by the ACTG Scientific Agenda Steering committee.
All participants will receive Decavac vaccination on Day 0, and a Twinrix vaccination on Days 0, 7, and 21. Study visits will occur around Days 0, 7, and 21, and at Weeks 6, 8, 12, and 24; all visits will include medical and medication history, blood collection, and a physical exam. Medication to treat HCV or HIV will not be provided by the study.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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A
HCV-infected defined as a positive result using polymerase chain reaction (PCR) without previous HCV-based therapy and without the presence of Child's B or C cirrhosis. These participants will be HIV-uninfected.
Twinrix
Combined hepatitis A and hepatitis B immunization
Decavac
Diphtheria and tetanus toxoid vaccine
B
HIV-infected and ARV naive, with a CD4 cell count of 300 cells/mm3 or greater, with no prior or current opportunistic infection, and with no indication for HIV therapy. These participants will be HCV-uninfected.
Twinrix
Combined hepatitis A and hepatitis B immunization
Decavac
Diphtheria and tetanus toxoid vaccine
C
HCV/HIV-coinfected as defined above in Arms A and B.
Twinrix
Combined hepatitis A and hepatitis B immunization
Decavac
Diphtheria and tetanus toxoid vaccine
Interventions
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Twinrix
Combined hepatitis A and hepatitis B immunization
Decavac
Diphtheria and tetanus toxoid vaccine
Eligibility Criteria
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Inclusion Criteria
* HIV-uninfected
* HIV-infected
* HCV-uninfected
* CD4 count greater than or equal to 300 cells/mm3 within 60 days prior to study entry
* HIV-infected
* HCV-infected
* Documented hepatitis B virus (HBV) antibody status. If anti-HBV core antibody positive, documented HBV negative test within 30 days prior to study entry is required.
* Willing to use acceptable forms of contraception for the duration of the study and for 24 weeks after the last vaccination
Exclusion Criteria
* Current, prior, or clinical need for antiretroviral therapy (within the past three months prior to study entry)
* Opportunistic infection other than HCV
* Concurrent or recent treatment for HCV infection (within the past three months)
* Current, prior, or clinical need for antiretroviral therapy (within the past three months prior to study entry). More information on this criterion can be found in the protocol.
* Opportunistic infection other than HCV
* History of exposure to hepatitis A vaccine, hepatitis B vaccine, or combined hepatitis A-hepatitis B vaccines
* Immunomodulatory agents for 7 days or more within 30 days prior to study entry. More information on this criterion can be found in the protocol.
* Concurrent immunizations (e.g., influenza, pneumococcal, other vaccine)within 3 days prior to study entry
* Active or recent (in the last six months prior to study entry) CDC Category C event. More information on this criterion can be found in the protocol
* Systemic anticancer chemotherapy or radiation within 24 weeks prior to study entry, or anticipated need to begin such treatment
* Past or current immunologically-mediated disease. More information on this criterion can be found in the protocol.
* Current bacterial infection requiring treatment, therapy, or hospitalization within 1 week prior to study entry
* Serious illness requiring systemic treatment and/or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
* Current uncontrolled seizure disorders
* Active bleeding varices, or Child's B or C cirrhosis. More information on this criterion can be found in the protocol.
* Serious bleeding disorder that poses a risk to a participant for intramuscular injections
* Known allergy or sensitivity to study vaccines or their formulations
* Current drug or alcohol use that, in the opinion of the investigator, interferes with study participation
* Pregnant or breastfeeding
* Use of systemic investigational agents within 30 days prior to entry
* History of any hepatitis A vaccine within one year
18 Years
65 Years
ALL
No
Sponsors
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Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Donald D. Anthony, MD, PhD
Role: STUDY_CHAIR
Case Western Reserve University
Benigno Rodriguez, MD
Role: STUDY_CHAIR
Division of Infectious Diseases, University Hospital of Cleveland
Locations
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UCSD Antiviral Research Center CRS
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
IHV Baltimore Treatment CRS
Baltimore, Maryland, United States
Massachusetts General Hospital Clinical Research Site (MGH CRS) CRS
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Case CRS
Cleveland, Ohio, United States
MetroHealth CRS
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Trinity Health and Wellness Center CRS
Dallas, Texas, United States
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, , Puerto Rico
Countries
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References
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Maier I, Wu GY. Hepatitis C and HIV co-infection: a review. World J Gastroenterol. 2002 Aug;8(4):577-9. doi: 10.3748/wjg.v8.i4.577.
Rockstroh JK. Management of hepatitis B and C in HIV co-infected patients. J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S59-65. doi: 10.1097/00126334-200309011-00009.
Sulkowski MS, Mast EE, Seeff LB, Thomas DL. Hepatitis C virus infection as an opportunistic disease in persons infected with human immunodeficiency virus. Clin Infect Dis. 2000 Apr;30 Suppl 1:S77-84. doi: 10.1086/313842.
Other Identifiers
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10154
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5232
Identifier Type: -
Identifier Source: secondary_id
A5232
Identifier Type: -
Identifier Source: org_study_id