Trial Outcomes & Findings for Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels (NCT NCT00987948)

NCT ID: NCT00987948

Last Updated: 2017-03-22

Results Overview

Week 24 minus baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline to 24 weeks
• Results posted on: 2017-03-22

Participant Flow

Participant milestones

Measure	Maraviroc maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Maraviroc Intensification and Peripheral Blood Monocyte HIV DNA Levels

Baseline characteristics by cohort

Measure	Maraviroc n=15 Participants maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 24 weeks

Population: Outcome measure in the 12 patients who completed the study.

Week 24 minus baseline

Outcome measures

Measure	Maraviroc n=12 Participants maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Change From Baseline to 24 Weeks in HIV DNA (Log-10 Copies/10^6 Cells) as Measured by HIV DNA Within CD14+ Peripheral Blood Mononuclear Cells	0.58 Log-10 copies/10^6 cells Interval 0.0 to 2.2

SECONDARY outcome

Timeframe: Baseline to 24 Weeks

Population: 6 of 12 patients who completed the study who had mild to moderate cognitive impairment

The Z-score represents the number of standard deviations away from the mean, with positive Z-scores representing better neuropsychological performance and negative Z-scores representing poorer neuropsychological performance. Z-scores have been adjusted based on age- and education-matched norms.

Outcome measures

Measure	Maraviroc n=6 Participants maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Change From Baseline to 24 Weeks in Neuropsychological Performance As Measured by Age- and Education-Adjusted Z-Scores	0.57 Z-score Interval 0.35 to 1.07

Adverse Events

Maraviroc

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Maraviroc n=15 participants at risk maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
Endocrine disorders Pancreatitis	6.7% 1/15 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Cecilia M Shikuma

Hawaii Center for AIDS, University of Hawaii

Phone: 8086921328

Email: shikuma@hawaii.edu

Results disclosure agreements

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