 |
 |
 |
A5232 - Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness: A Pilot Study
Eligible candidates:
- Ages 18-65
- Negative for Hepatitis A antibody, Hepatitis B surface antibody and Hepatitis B surface antigen
- CD4 count greater than 300 cells/mm3 within 60 days of entry into the study
- For Arm A: chronic HCV infection
- For Arm B: chronic HIV-1 infection, and have never been on HIV medications
- For Arm C: chronic HIV-1 and HCV co-infection.
- Additional requirements will be discussed by the study nurse or doctor
- Arm-specific Requirements (all volunteers must fall into one of these arms (categories):
Study Objective:
A5232 is a pilot study investigating the extent of immune defects in people who have Hepatitis C, HIV, or both.
This will be done by immunizing people with antibodies to hepatitis A and B, and evaluating immunological
response.
Study Scheme:
Participants will be on study for 24 weeks. 66 participants will be enrolled, each into one of the 3 study arms:
- Arm A: 22 subjects with chronic Hepatitis C (HCV) infection defined as PCR positive without previous HCV-based therapy and without the presence of Child’s B or C cirrhosis. These subjects will be HIV-1 seronegative.
- Arm B: 22 antiretroviral treatment-naive subjects (< 7 days of antiretroviral therapy) with chronic HIV-1 infection (as defined in section 4.1.1), CD4+ T-cell count = 300 cells/mm3, no prior or current opportunistic infection, and with no indication for HIV-1 therapy. These subjects will be HCV seronegative.
- Arm C: 22 subjects with HCV/HIV-1 coinfection as defined above in Arms A and B
Study Drugs:
- Twinrix (Hepatitis B vaccine)
- Decavax (diphtheria/tetanus toxoid vaccine)
Study Status: Open for enrollment.
Study Staff:
- Judith Aberg, MD
- Janet Forcht, RN
- Luis Vargas
Study Sponsors:
- AIDS Clinical Trials Group (NIH)
The Study will provide:
- Cost-free vaccinations and lab work
- Transportation reimbursement