Phase 3 N=52 Randomized Quadruple-blind Treatment

Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

HIV Infection · Cardiovascular Disease · Inflammation · HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00844519 ↗

Enrolled (actual)

Serious AEs

1.9%

Results posted

Jun 2014

Primary outcome: Primary: Percent Change in FMD — 0.57; -0.05 percent change in FMD — p=0.17

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Maraviroc (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in FMD	0.57; -0.05	0.17

Summary

The purpose of this study is to determine the potentially beneficial aspects of CCR5 inhibition on inflammation and endothelial function as measured by brachial artery reactivity in antiretroviral treated HIV patients with an undetectable viral load.

Eligibility Criteria

Inclusion Criteria

Stable antiretroviral therapy for at least 12 months
All plasma HIV RNA levels within the past year must be below level of detection ( 50 but 90% adherence to therapy within the preceding 30 days, as determined by self-report
Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion Criteria

Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
Concurrent or recent exposure to any immunomodulatory drugs
Advanced liver disease or active hepatitis B or C
Patients with systolic blood pressure <100/70
Starting or stopping statin therapy during the trial

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00844519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.