Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

This study is currently recruiting participants.

Verified by University of California, San Francisco, February 2009

First Received: February 13, 2009 Last Updated: March 9, 2009 History of Changes

Sponsors and Collaborators:	University of California, San Francisco National Heart, Lung, and Blood Institute (NHLBI) Pfizer
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00844519

Purpose

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.

Condition	Intervention	Phase
HIV Infection Endothelial Function Cardiovascular Disease Inflammation HIV Infections	Drug: Maraviroc Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Maraviroc

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

endothelial function as assessed by vasodilation of the brachial artery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Maraviroc: 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.	Drug: 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: Placebo Comparator	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 copies RNA/mL), although isolated single values > 50 but < 200 copies will be allowed.
Screening plasma HIV RNA levels < 50 copies RNA/mL
>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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00844519

Contacts

Contact: Priscilla Hsue, MD	4152068257	phsue@medsfgh.ucsf.edu
Contact: Amanda Schnell, BA	4152065461	aschnell@medsfgh.ucsf.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

National Heart, Lung, and Blood Institute (NHLBI)

Pfizer

More Information

No publications provided

Responsible Party:	Univeristy of California, San Francisco ( Priscilla Hsue/Assistant Professor of Medicine )
Study ID Numbers:	HIVCADRFA
Study First Received:	February 13, 2009
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00844519 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Treatment Experienced
CCR5 receptor
maraviroc

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes
Inflammation

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes

Inflammation
Virus Diseases
Pathologic Processes
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Cardiovascular Diseases
Retroviridae Infections

ClinicalTrials.gov processed this record on September 01, 2009