Trial Outcomes & Findings for Evaluating the Effectiveness of Pentoxifylline at Improving Blood Vessel Function in HIV-infected People Not Receiving Antiretroviral Medications (NCT NCT00796822)

Last Updated: 2017-11-28

Results Overview

Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Measured at baseline and Week 8

Results posted on

2017-11-28

Participant Flow

Study recruitment, enrollment, and follow-up assessments were performed from May 2009 through October 2011, at the HIV outpatient clinics of the Indiana University Health medical system.

Potential participants underwent a screening visit to evaluate eligibility within 21 days of randomization.

Participant milestones

Participant milestones
Measure	Pentoxifylline Participants will receive pentoxifylline. Pentoxifylline : 400 mg three times a day for 8 weeks	Placebo Participants will receive placebo. Placebo : One pill three times a day for 8 weeks
Overall Study STARTED	13	13
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pentoxifylline Participants will receive pentoxifylline. Pentoxifylline : 400 mg three times a day for 8 weeks	Placebo Participants will receive placebo. Placebo : One pill three times a day for 8 weeks
Overall Study Lost to Follow-up	2	0
Overall Study Adverse Event	1	0

Baseline Characteristics

Evaluating the Effectiveness of Pentoxifylline at Improving Blood Vessel Function in HIV-infected People Not Receiving Antiretroviral Medications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pentoxifylline n=13 Participants Participants will receive pentoxifylline. Pentoxifylline : 400 mg three times a day for 8 weeks	Placebo n=13 Participants Participants will receive placebo. Placebo : One pill three times a day for 8 weeks	Total n=26 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	13 Participants n=5 Participants	13 Participants n=7 Participants	26 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	34 years STANDARD_DEVIATION 10.9 • n=5 Participants	40 years STANDARD_DEVIATION 11.6 • n=7 Participants	37 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and Week 8

Population: Number of remaining participants at week 8 with evaluable vascular ultrasonography. In the Pentoxifylline group, 10 participants were evaluated at week 8 but only 9 had evaluable ultrasonography.

Flow-mediated dilation is nn in vivo measure of arterial endothelial function. We assessed changes in flow-mediated dilation from baseline to week 8.

Outcome measures

Outcome measures
Measure	Pentoxifylline n=9 Participants Participants will receive pentoxifylline. Pentoxifylline : 400 mg three times a day for 8 weeks	Placebo n=13 Participants Participants will receive placebo. Placebo : One pill three times a day for 8 weeks
Change in Flow-mediated Dilation of the Brachial Artery	-1.93 absolute percentage Standard Deviation 3.03	-1.06 absolute percentage Standard Deviation 1.45

SECONDARY outcome

Timeframe: Measured at baseline and Week 8

Population: Those who had both baseline and Week 8 data available

Measure of systemic inflammation

Outcome measures

Outcome measures
Measure	Pentoxifylline n=10 Participants Participants will receive pentoxifylline. Pentoxifylline : 400 mg three times a day for 8 weeks	Placebo n=13 Participants Participants will receive placebo. Placebo : One pill three times a day for 8 weeks
Change in Soluble TNF-Receptor I Levels	65.9 pg/mL Standard Deviation 168.97	-83.2 pg/mL Standard Deviation 137.45

Adverse Events

Pentoxifylline

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pentoxifylline n=13 participants at risk Participants will receive pentoxifylline. Pentoxifylline : 400 mg three times a day for 8 weeks	Placebo n=13 participants at risk Participants will receive placebo. Placebo : One pill three times a day for 8 weeks
Gastrointestinal disorders All gastrointestinal	38.5% 5/13 • Number of events 7 • 8 weeks	38.5% 5/13 • Number of events 8 • 8 weeks
Skin and subcutaneous tissue disorders Rash	7.7% 1/13 • Number of events 1 • 8 weeks	15.4% 2/13 • Number of events 2 • 8 weeks
Skin and subcutaneous tissue disorders Flushing	0.00% 0/13 • 8 weeks	15.4% 2/13 • Number of events 2 • 8 weeks
General disorders Headache	15.4% 2/13 • Number of events 2 • 8 weeks	7.7% 1/13 • Number of events 1 • 8 weeks
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/13 • 8 weeks	15.4% 2/13 • Number of events 2 • 8 weeks
Blood and lymphatic system disorders Neutropenia	15.4% 2/13 • Number of events 2 • 8 weeks	0.00% 0/13 • 8 weeks
Renal and urinary disorders Hypokalemia	7.7% 1/13 • Number of events 1 • 8 weeks	0.00% 0/13 • 8 weeks
Renal and urinary disorders Hyperkalemia	0.00% 0/13 • 8 weeks	7.7% 1/13 • Number of events 1 • 8 weeks
Hepatobiliary disorders Elevated liver function tests	7.7% 1/13 • Number of events 1 • 8 weeks	7.7% 1/13 • Number of events 1 • 8 weeks
Endocrine disorders Hyperglycemia	7.7% 1/13 • Number of events 1 • 8 weeks	0.00% 0/13 • 8 weeks
Renal and urinary disorders Proteinuria	7.7% 1/13 • Number of events 1 • 8 weeks	0.00% 0/13 • 8 weeks

Additional Information

Dr. Samir K. Gupta

Indiana University School of Medicine

Phone: 317-274-7926

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place