Trial Outcomes & Findings for Autologous Dendritic Cell Vaccine in HIV1 Infection (NCT NCT00510497)

Results Overview

AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

80 weeks

Results posted on

2025-11-06

Participant milestones
Measure	Autologous HIV-1 ApB DC Vaccine Subjects who will receive ApB Dendritic cell vaccine Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Withdrawal data not reported

Autologous Dendritic Cell Vaccine in HIV1 Infection

Baseline characteristics by cohort
Measure	Autologous HIV-1 ApB DC Vaccine n=10 Participants Subjects who will receive ApB Dendritic cell vaccine Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=49 Participants
Age, Categorical >=65 years	0 Participants n=49 Participants
Age, Continuous	37.9 years n=49 Participants
Sex: Female, Male Female	0 Participants n=49 Participants
Sex: Female, Male Male	10 Participants n=49 Participants
Region of Enrollment United States	10 participants n=49 Participants

Timeframe: 80 weeks

AE graded by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004

Outcome measures
Measure	Autologous HIV-1 ApB DC Vaccine n=10 Participants Subjects who will receive ApB Dendritic cell vaccine Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
Safety and Tolerability of Autologous HIV-1 ApB DC Vaccine.	2 participants with Grade 3 events related

Timeframe: at the end of 12 weeks treatment interruption

Log10 Change in HIV RNA set point comparing pre-ART to 12 weeks after treatment interruption

Outcome measures
Measure	Autologous HIV-1 ApB DC Vaccine n=10 Participants Subjects who will receive ApB Dendritic cell vaccine Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
Virologic Efficacy (HIV-1 Viral Load at End of ATI Minus Viral Load Prior to ART)	-0.21 log10 HIV RNA Interval -0.6 to 0.22

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Autologous HIV-1 ApB DC Vaccine n=10 participants at risk Subjects who will receive ApB Dendritic cell vaccine (does not include one enrolled participant who received no study treatment) Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption
Skin and subcutaneous tissue disorders grade 3 severe pruritus and injection site pain	20.0% 2/10 • Number of events 2

University of Pittsburgh

Phone: 412-383-1675

Restriction type: GT60