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Status:

COMPLETED

Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Conditions:

HIV Infections

Hepatitis C

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The purpose of this study is to investigate the immune responses to two different vaccine formulations in HIV-infe...

Detailed Description

Individuals with HCV and HIV coinfection are especially hard to treat, and as a result, account for a high rate of deaths each year. Because HCV and HIV share transmission routes, HCV/HIV coinfection ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for Arm A Participants:
  • HCV-infected
  • HIV-uninfected
  • Inclusion Criteria for Arm B Participants:
  • HIV-infected
  • HCV-uninfected
  • CD4 count greater than or equal to 300 cells/mm3 within 60 days prior to study entry
  • Inclusion Criteria for Arm C Participants:
  • HIV-infected
  • HCV-infected
  • Inclusion Criteria for All Participants:
  • 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 for Arm A Participants:
  • Concurrent or recent treatment for HCV infection (within the past three months)
  • Exclusion Criteria for Arm B Participants:
  • Current, prior, or clinical need for antiretroviral therapy (within the past three months prior to study entry)
  • Opportunistic infection other than HCV
  • Exclusion Criteria for Arm C Participants:
  • 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
  • Exclusion Criteria for All Participants:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2009

    Estimated Enrollment :

    29 Patients enrolled

    Trial Details

    Trial ID

    NCT00393276

    Start Date

    August 1 2007

    End Date

    July 1 2009

    Last Update

    November 1 2021

    Active Locations (12)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (12 locations)

    1

    UCSD Antiviral Research Center CRS

    San Diego, California, United States, 92103

    2

    Ucsf Aids Crs

    San Francisco, California, United States, 94110

    3

    University of Colorado Hospital CRS

    Aurora, Colorado, United States, 80045

    4

    IHV Baltimore Treatment CRS

    Baltimore, Maryland, United States, 21201