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Autologous Dendritic Cell Vaccine in HIV1 Infection

CompletedPhase 1, Phase 2

Sponsor: Sharon Riddler

Conditions: HIV Infections

Interventions: Autologous HIV-1 ApB DC Vaccine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Pittsburgh, Pennsylvania, United States