Overview

This trial is active, not recruiting.

Conditions hiv infection, cardiovascular disease, inflammation, hiv infections
Treatments maraviroc, placebo
Phase phase 3
Sponsor University of California, San Francisco
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2010
End date December 2012
Trial size 52 participants
Trial identifier NCT00844519, HIVCADRFA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
For subjects assigned to the maraviroc group, subjects will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medication. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
maraviroc
For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.
(Placebo Comparator)
placebo
For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.

Primary Outcomes

Measure
Percent Change in FMD
time frame: Baseline, 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Stable antiretroviral therapy for at least 12 months 2. All plasma HIV RNA levels within the past year must be below level of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 200 copies will be allowed. 3. Screening plasma HIV RNA levels < 50 copies RNA/mL 4. >90% adherence to therapy within the preceding 30 days, as determined by self-report 5. 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: 1. Ongoing or prior use of any integrase inhibitor or R5 inhibitor. 2. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason 3. Serious illness requiring hospitalization or parental antibiotics within preceding 3 months 4. Concurrent or recent exposure to any immunomodulatory drugs 5. Advanced liver disease or active hepatitis B or C 6. Patients with systolic blood pressure <100/70 7. Starting or stopping statin therapy during the trial

Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University of California, San Francisco.