Trial Outcomes & Findings for Effect of Maraviroc on Endothelial Function in HIV-Infected Patients (NCT NCT00844519)

NCT ID: NCT00844519

Last Updated: 2014-07-24

Results Overview

endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 52 participants
• Primary outcome timeframe: Baseline, 24 weeks
• Results posted on: 2014-07-24

Participant Flow

Participant milestones

Measure	Maraviroc maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.	Placebo matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
Overall Study STARTED	26	26
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Maraviroc maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.	Placebo matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	1	0

Baseline Characteristics

Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

Baseline characteristics by cohort

Measure	Maraviroc n=26 Participants maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.	Placebo n=26 Participants matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.	Total n=52 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	52 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	26 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 24 weeks

endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery

Outcome measures

Measure	Maraviroc n=26 Participants maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.	Placebo n=26 Participants matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
Percent Change in FMD	0.57 percent change in FMD Standard Deviation 2.1	-0.05 percent change in FMD Standard Deviation 2.1

Adverse Events

Maraviroc

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Maraviroc n=26 participants at risk maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.	Placebo n=26 participants at risk matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
Surgical and medical procedures hepatocellular carcinoma	3.8% 1/26 • Number of events 1	0.00% 0/26

Other adverse events

Adverse event data not reported

Additional Information

Dr. Priscilla Hsue

University of California San Francisco

Phone: 415-206-8257

Email: phsue@medsfgh.ucsf.edu

Results disclosure agreements

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