Autologous Dendritic Cell Vaccine in HIV1 Infection

Sharon Riddler

Status and phase

Completed

Phase 2

Phase 1

Conditions

HIV Infections

Treatments

Biological: Autologous HIV-1 ApB DC Vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00510497

5U19AI055794 (U.S. NIH Grant/Contract)

Riddler 055794

Details and patient eligibility

About

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.

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.