Trial Outcomes & Findings for Pentoxifylline and Combination Antiretroviral Therapy to Improve Blood Vessel Function in HIV-Infected People (NCT NCT00864916)

Results Overview

Flow-mediated dilation (% dilation of the brachial artery) at week 48

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Measured at Week 48

Results posted on

2014-05-12

Participant milestones
Measure	PTX+cART Participants will receive pentoxifylline and combination antiretroviral therapy (cART). Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.	Placebo+cART Participants will receive placebo and cART. Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Placebo: Participants will receive placebo three times per day for 48 weeks.
Overall Study STARTED	10	9
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal
Measure	PTX+cART Participants will receive pentoxifylline and combination antiretroviral therapy (cART). Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.	Placebo+cART Participants will receive placebo and cART. Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Placebo: Participants will receive placebo three times per day for 48 weeks.
Overall Study Lost to Follow-up	4	4
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	1	0

Pentoxifylline and Combination Antiretroviral Therapy to Improve Blood Vessel Function in HIV-Infected People

Baseline characteristics by cohort
Measure	PTX+cART n=10 Participants Participants will receive pentoxifylline and combination antiretroviral therapy (cART). Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.	Placebo+cART n=9 Participants Participants will receive placebo and cART. Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Placebo: Participants will receive placebo three times per day for 48 weeks.	Total n=19 Participants Total of all reporting groups
Age, Continuous	37.8 years STANDARD_DEVIATION 12.1 • n=5 Participants	34.0 years STANDARD_DEVIATION 8.8 • n=7 Participants	36.0 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

Timeframe: Measured at Week 48

Population: Numbers of participants who completed the week 48 visit procedures

Flow-mediated dilation (% dilation of the brachial artery) at week 48

Outcome measures
Measure	PTX+cART n=4 Participants Participants will receive pentoxifylline and combination antiretroviral therapy (cART). Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.	Placebo+cART n=5 Participants Participants will receive placebo and cART. Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Placebo: Participants will receive placebo three times per day for 48 weeks.
Flow-mediated Dilation of the Brachial Artery	2.25 percent dilation of the brachial artery Standard Deviation 2.92	3.36 percent dilation of the brachial artery Standard Deviation 1.44

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	PTX+cART n=10 participants at risk Participants will receive pentoxifylline and combination antiretroviral therapy (cART). Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks.	Placebo+cART n=9 participants at risk Participants will receive placebo and cART. Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.) Placebo: Participants will receive placebo three times per day for 48 weeks.
Gastrointestinal disorders Gastrointestinal upset	60.0% 6/10	22.2% 2/9

Indiana University School of Medicine

Phone: 317-274-7926