Trial Outcomes & Findings for Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection (NCT NCT00594880)

NCT ID: NCT00594880

Last Updated: 2015-02-10

Results Overview

% of individuals maintaining viral suppression (VL \< 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2015-02-10

Participant Flow

locations: medical clinics (Hospital of the University of Pennsylvania, Jonathan Lax clinic, Drexel University Hospital) Recruitment period: may 8, 2008 to May 27, 2010

subjects were randomized to the pegasys dose of 180 or 90 mcg/week four weeks after enrollment (week 0: eligibility determination; week 4: enrollment; week 8: randomization and treatment initiation; week 13: ART interruption; week 25: primary endpoint; week 37: secondary endpoints)

Participant milestones

Measure	Pegasys 180 mcg/Week ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Pegasys 90 mcg/Week ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
Overall Study STARTED	12	11
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Pegasys 180 mcg/Week ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Pegasys 90 mcg/Week ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection

Baseline characteristics by cohort

Measure	Pegasys 180 mcg/Week n=12 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Pegasys 90 mcg/Week n=11 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous Age	45.5 years n=5 Participants	44 years n=7 Participants	45 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: excluded 2 withdrawal of consent and 1 lost to follow-up

% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)

Outcome measures

Measure	Pegasys 180 mcg/Week n=10 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Pegasys 90 mcg/Week n=10 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
HIV Viral Load < 400 Copies/ml	40 percentage of participants	50 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: % of subjects maintaining VL \< 48 copies/ml after 12 weeks of treatment

% of individuals maintaining VL < 48 copies/ml while on pegylated interferon alpha-2a treatment without ART

Outcome measures

Measure	Pegasys 180 mcg/Week n=10 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Pegasys 90 mcg/Week n=10 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
HIV Viral Load < 48 Copies/ml	10 percentage of participants	30 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: percent of consenting eligible participants (n=8) with VL \< 400 at week 24 of treatment

% of individuals maintaining viral suppression (VL < 400 copies/ml) as compared to the anticipated rate of viral suppression in individuals interrupting ART without interferon (9%)

Outcome measures

Measure	Pegasys 180 mcg/Week n=3 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Pegasys 90 mcg/Week n=5 Participants ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
HIV Viral Load < 400 Copies/ml	67 percentage of eligible participants	80 percentage of eligible participants

Adverse Events

Pegasys 180 mcg/Week

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Pegasys 90 mcg/Week

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pegasys 180 mcg/Week n=12 participants at risk ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints	Pegasys 90 mcg/Week n=11 participants at risk ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL \< 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints
Psychiatric disorders depression	8.3% 1/12 • Number of events 1	18.2% 2/11 • Number of events 2
Blood and lymphatic system disorders Neutropenia	8.3% 1/12 • Number of events 1	0.00% 0/11
Hepatobiliary disorders Liver toxicity	0.00% 0/12	9.1% 1/11 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Luis Montaner

the Wistar Institute

Phone: 215 898 3934

Email: montaner@mail.wistar.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place