Effect of Maraviroc on Endothelial Function in HIV-Infected Patients

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NCT00844519

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Study Location
University of California, San Francisco
San Francisco, California, 94110, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infection, Cardiovascular Disease, Inflammation, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Pfizer Clinical Trials Contact Center

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HIV Infection, Cardiovascular Disease, Inflammation, HIV InfectionsEffect of Maraviroc on Endothelial Function in HIV-Infected Patients
NCT00844519
  1. San Francisco, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infection
  • Cardiovascular Disease
  • Inflammation
  • HIV Infections
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Maraviroc
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2014)		52
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2009)		50
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00844519
Other Study ID Numbers  ICMJE HIVCADRFA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pfizer
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP