Trial Outcomes & Findings for ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study (NCT NCT01535235)

NCT ID: NCT01535235

Last Updated: 2016-06-16

Results Overview

Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 31 participants
• Primary outcome timeframe: 22 weeks
• Results posted on: 2016-06-16

Participant Flow

The trial over enrolled by one individual as one participant discontinued the study after enrollment due to an adverse event.

Participant milestones

Measure	ACE Inhibitor Active group Lisinopril: Lisinopril 20mg QD x 24 weeks	Placebo Placebo group Placebo: Placebo QD x24wks
Overall Study STARTED	16	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	ACE Inhibitor Active group Lisinopril: Lisinopril 20mg QD x 24 weeks	Placebo Placebo group Placebo: Placebo QD x24wks
Overall Study Adverse Event	1	0

Baseline Characteristics

ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study

Baseline characteristics by cohort

Measure	ACE Inhibitor n=16 Participants Active group Lisinopril: Lisinopril 20mg Daily x 24 weeks	Placebo n=15 Participants Placebo group Placebo: Placebo Daily x24wks	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	53 years n=93 Participants	54 years n=4 Participants	54 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Race/Ethnicity, Customized White	14 participants n=93 Participants	9 participants n=4 Participants	23 participants n=27 Participants
Race/Ethnicity, Customized Black/African American	2 participants n=93 Participants	1 participants n=4 Participants	3 participants n=27 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 participants n=93 Participants	3 participants n=4 Participants	3 participants n=27 Participants
Race/Ethnicity, Customized Asian	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Race/Ethnicity, Customized Pacific Islander	0 participants n=93 Participants	1 participants n=4 Participants	1 participants n=27 Participants
Region of Enrollment United States	16 participants n=93 Participants	15 participants n=4 Participants	31 participants n=27 Participants
CD4+ T cell count	349 cells/mm^3 n=93 Participants	392 cells/mm^3 n=4 Participants	362 cells/mm^3 n=27 Participants

PRIMARY outcome

Timeframe: 22 weeks

Population: Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.

Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline

Outcome measures

Measure	ACE Inhibitor n=15 Participants Active group Lisinopril: Lisinopril 20mg QD x 24 weeks	Placebo n=12 Participants Placebo group Placebo: Placebo QD x24wks
Change in HIV RNA (Copies/Million Rectal Cells)	1.1 copies/million rectal cells Interval -74.5 to 62.5	-0.2 copies/million rectal cells Interval -55.8 to 96.4

SECONDARY outcome

Timeframe: 22 weeks

Population: Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.

Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline

Outcome measures

Measure	ACE Inhibitor n=15 Participants Active group Lisinopril: Lisinopril 20mg QD x 24 weeks	Placebo n=12 Participants Placebo group Placebo: Placebo QD x24wks
Change in HIV DNA (Copies/Million Rectal Cells)	-38.4 copies/million rectal cells Interval -76.3 to 114.8	-53.8 copies/million rectal cells Interval -102.9 to 87.3

Adverse Events

ACE Inhibitor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ACE Inhibitor n=16 participants at risk Active group Lisinopril: Lisinopril 20mg QD x 24 weeks	Placebo n=15 participants at risk Placebo group Placebo: Placebo QD x24wks
Renal and urinary disorders Elevation in serum creatinine	6.2% 1/16 • Number of events 1	0.00% 0/15

Additional Information

Dr. Leslie Cockerham

Medical College of Wisconsin

Phone: 414-805-0738

Email: lcockerham@mcw.edu

Results disclosure agreements

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