Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00844519
First received: February 13, 2009
Last updated: July 16, 2014
Last verified: July 2014
  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
Cardiovascular Disease
Inflammation
HIV Infections
Drug: Maraviroc
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Change in FMD [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
    endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery


Enrollment: 52
Study Start Date: January 2010
Study Completion Date: June 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Maraviroc
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 Comparator: Placebo 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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Pfizer
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00844519     History of Changes
Other Study ID Numbers: HIVCADRFA
Study First Received: February 13, 2009
Results First Received: May 19, 2014
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Treatment Experienced
CCR5 receptor
maraviroc

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Communicable Diseases
HIV Infections
Infection
Inflammation
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014