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Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

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ClinicalTrials.gov Identifier: NCT00844519
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : June 19, 2014
Last Update Posted : July 24, 2014
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infection Cardiovascular Disease Inflammation HIV Infections Drug: Maraviroc Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percent Change in FMD [ Time Frame: Baseline, 24 weeks ]
    endothelial function as assessed by measured flow-mediated vasodilation (FMD) of the brachial artery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00844519


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00844519     History of Changes
Other Study ID Numbers: HIVCADRFA
First Posted: February 16, 2009    Key Record Dates
Results First Posted: June 19, 2014
Last Update Posted: July 24, 2014
Last Verified: July 2014

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Inflammation
HIV Infections
Acquired Immunodeficiency Syndrome
Cardiovascular Diseases
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents