Trial Outcomes & Findings for Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV (NCT NCT01935089)

Last Updated: 2023-07-06

Results Overview

Difference in copies of HIV DNA per CD4+ T cell between baseline and week 24, assessed by Alu-HIVgag polymerase chain reaction

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Week 3 and 24

Results posted on

2023-07-06

22 screened

Participant milestones
Measure	Interferon Alpha pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks Pegylated Interferon alpha 2b: 1µg/kg/week
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal
Measure	Interferon Alpha pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks Pegylated Interferon alpha 2b: 1µg/kg/week
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1

Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV

Baseline characteristics by cohort
Measure	Interferon Alpha n=20 Participants pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks Pegylated Interferon alpha 2b: 1µg/kg/week
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
CD4 count	591 cells/ul n=5 Participants

Timeframe: Week 3 and 24

Population: outcome measure available only for 17 individuals

Difference in copies of HIV DNA per CD4+ T cell between baseline and week 24, assessed by Alu-HIVgag polymerase chain reaction

Outcome measures
Measure	Interferon Alpha n=17 Participants pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks Pegylated Interferon alpha 2b: 1µg/kg/week
Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24 Baseline	113 HIV DNA copies per CD4+ T cell Interval 65.0 to 371.0
Change From Baseline in Copies of HIV DNA Per CD4+ T Cell at Week 24 Week 24	98 HIV DNA copies per CD4+ T cell Interval 60.0 to 406.5

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Interferon Alpha n=20 participants at risk pegylated Interferon alpha 2b (Pegintron) 1 µg/kg per week, 20 weeks Pegylated Interferon alpha 2b: 1µg/kg/week
Blood and lymphatic system disorders Neutropenia	30.0% 6/20 • Number of events 6
Nervous system disorders Depression	15.0% 3/20 • Number of events 3

The Wistar Institute

Phone: +1 (215) 898-9143