Trial Outcomes & Findings for A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects (NCT NCT02597790)

Results Overview

Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)

Recruitment status

COMPLETED

Target enrollment

87 participants

Primary outcome timeframe

Baseline

Results posted on

2022-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Group A (HIV/HCV Coinfected) HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) HIV+, HCV negative at study entry
Overall Study STARTED	45	41
Overall Study COMPLETED	36	29
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A (HIV/HCV Coinfected) n=45 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=41 Participants HIV+, HCV negative at study entry	Total n=86 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	52 years n=7 Participants	52 years n=5 Participants
Sex/Gender, Customized Gender · Men	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Sex/Gender, Customized Gender · Women	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex/Gender, Customized Gender · Transgender women	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black Non-Hispanic	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White Non-Hispanic	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Body mass index (kg/m2)	27.6 kg/m2 n=5 Participants	26.0 kg/m2 n=7 Participants	26.3 kg/m2 n=5 Participants
Hypertension	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Dyslipidemia	7 Participants n=5 Participants	25 Participants n=7 Participants	32 Participants n=5 Participants
CD4+ T cell count	587 cells/mm3 n=5 Participants	636 cells/mm3 n=7 Participants	612 cells/mm3 n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=45 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=41 Participants HIV+, HCV negative at study entry
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)	1.98 ratio Interval 1.79 to 2.48	2.15 ratio Interval 1.71 to 2.58

SECONDARY outcome

Timeframe: Baseline

Population: All participants with available data.

Serum hsCRP

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=35 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=41 Participants HIV+, HCV negative at study entry
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)	0.6 mg/L Interval 0.2 to 2.1	1.3 mg/L Interval 0.8 to 2.8

SECONDARY outcome

Timeframe: Week 52

Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=31 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=29 Participants HIV+, HCV negative at study entry
Reactive Hyperemia Index (RHI)	1.88 ratio Interval 1.65 to 2.55	2.09 ratio Interval 1.64 to 2.42

SECONDARY outcome

Timeframe: Week 52

Population: All participants with available data.

Serum hsCRP

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=30 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=16 Participants HIV+, HCV negative at study entry
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)	1.05 mg/L Interval 0.4 to 2.5	1.0 mg/L Interval 0.75 to 1.4

SECONDARY outcome

Timeframe: Baseline

Population: All participants with available data.

fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=35 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=41 Participants HIV+, HCV negative at study entry
Insulin Resistance by HOMA-IR	3.86 HOMA-IR score Interval 1.7 to 5.4	2.24 HOMA-IR score Interval 1.36 to 3.17

SECONDARY outcome

Timeframe: Week 52

Population: All participants with available data

fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=30 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=16 Participants HIV+, HCV negative at study entry
Insulin Resistance by HOMA-IR	2.77 HOMA-IR score Interval 2.06 to 4.72	2.13 HOMA-IR score Interval 1.33 to 4.78

SECONDARY outcome

Timeframe: Baseline

Population: All participants with available data

Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is \<1 to \>/= 30% Higher risk % is worse predicted outcome.

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=45 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=41 Participants HIV+, HCV negative at study entry
Framingham Risk Score (FRS), 10-year Risk (%)	6.0 percent, 10-year risk Interval 2.0 to 8.0	6.0 percent, 10-year risk Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: Week 52

Population: All participants with available data

Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is \<1 to \>/= 30% Higher risk % is worse predicted outcome.

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=30 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=16 Participants HIV+, HCV negative at study entry
Framingham Risk Score (FRS), 10-year Risk (%)	6.0 percent, 10-year risk Interval 4.0 to 8.0	5.0 percent, 10-year risk Interval 1.0 to 8.0

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: All with available data

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=31 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=29 Participants HIV+, HCV negative at study entry
Change in RHI	-0.16 ratio Interval -0.43 to -0.06	-0.03 ratio Interval -0.32 to 0.05

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: All participants with available data

Change in serum hsCRP level

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=27 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=16 Participants HIV+, HCV negative at study entry
Change in Level of Each Soluble Biomarker (Components of Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)	0.40 mg/L Interval 0.0 to 1.2	0.00 mg/L Interval -0.45 to 0.45

SECONDARY outcome

Timeframe: Baseline to Week 52

Population: All participants with available data

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=27 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=16 Participants HIV+, HCV negative at study entry
Change in HOMA-IR	0.34 HOMA-IR score Interval -1.23 to 1.66	0.28 HOMA-IR score Interval -0.59 to 1.82

SECONDARY outcome

Timeframe: Baseline to Week 52

Change in estimated 10-year risk (% risk) for developing coronary heart disease (CHD). Positive value indicates increase in estimated 10-year risk for CHD from baseline to Week 52. Negative value indicates decrease in estimated 10-year risk for CHD from baseline to Week 52.

Outcome measures

Outcome measures
Measure	Group A (HIV/HCV Coinfected) n=27 Participants HIV+, HCV viremic at study entry	Group B (HIV Monoinfected) n=16 Participants HIV+, HCV negative at study entry
Change in Framingham Risk Score (10-year Risk, %)	1.0 percent Interval 0.0 to 2.0	0 percent Interval -1.0 to 0.5

Adverse Events

Group A (HIV/HCV Coinfected)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B (HIV Monoinfected)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kara Chew, MD, MS

David Geffen School of Medicine at UCLA

Phone: 310-825-0796

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60