Phase I/II Evaluation of Therapeutic Immunization With Autologous Dendritic Cells Pulsed With Autologous, Inactivated HIV-1 Infected, Apoptotic Cells
Overview
- Phase
- Phase 1
- Intervention
- Autologous HIV-1 ApB DC Vaccine
- Conditions
- HIV Infections
- Sponsor
- Sharon Riddler
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
This study aims to look at the safety and tolerability of immunization with dendritic cell vaccine prepared using the patient's own cells and virus. It also aims to explore the virologic efficacy of the vaccine as determined by a decrease in the viral load 12 weeks after analytic treatment interruption.
Detailed Description
This is a phase I/II, open label, single-arm, single-site clinical trial designed to evaluate the safety and antiviral activity of the ApB DC vaccine, a therapeutic vaccine derived from autologous dendritic cells loaded with autologous HIV-1 infected apoptotic cells. The study will be conducted in three phases. The first is the pre-vaccination phase that includes study entry, isolation of autologous virus, and initiation of antiretroviral therapy. Once the patient's viral load has been suppressed to undetectable levels (\<50 copies/mL) and sufficient virus has been isolated, the second phase will begin. This includes leukapheresis in order to harvest monocytes and lymphocytes necessary for vaccine preparation. Three vaccine doses will be administered subcutaneously every other week. Six weeks after the last vaccination, the third phase, analytic treatment interruption (ATI) phase, will begin. A fourth, booster dose of vaccine will be given two weeks after the start of treatment interruption. The treatment interruption will be continued for twelve weeks after which the primary HIV provider will decide whether or not antiretroviral therapy should be restarted. CD4 and viral load will be closely monitored throughout the study especially during treatment interruption. Follow-up will be continued for 24 weeks after the 12-week treatment interruption.
Investigators
Sharon Riddler
Associate Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Confirmed HIV-1 infection.
- •CD4 greater than or equal to 350 cells/mL within 8 weeks prior to study entry.
- •Plasma HIV-1 RNA level of 5000-100,000 copies/mL within 8 weeks prior to study entry.
- •Antiretroviral therapy naive.
- •Willingness to interrupt ART for at least 12 weeks.
- •Written informed consent.
Exclusion Criteria
- •Treatment within 30 days prior to study entry with systemic steroids or other immunosuppressives, or any underlying disease which may require use of such medications during the study period.
- •Receipt of any vaccinations other than routine ones within 6 months of study entry
- •Pregnancy or breastfeeding
- •Previous or current CDC Category C event
- •Receipt of any investigational product within 12 weeks prior to study entry.
Arms & Interventions
Autologous HIV-1 ApB DC Vaccine
Subjects who will receive ApB Dendritic cell vaccine
Intervention: Autologous HIV-1 ApB DC Vaccine
Outcomes
Primary Outcomes
Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.
Time Frame: 80 weeks
AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004
Secondary Outcomes
- Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)(at the end of 12 weeks treatment interruption)