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A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV

Primary Purpose

HIV-1-infection

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CVC 150 mg
CVC 300 mg
Placebo for CVC 150 mg
Placebo for CVC 300 mg
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV-1-infection focused on measuring HIV

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Documented HIV-1 infection. Currently on a stable, continuous NNRTI-based or unboosted INSTI-based ART regimen for ≥48 weeks prior to study entry with no ART interruption longer than 7 consecutive days and with no plans to change ART during the course of the study. Screening HIV-1 RNA level below the limit of quantification. All HIV-1 RNA levels within 48 weeks prior to study entry below the limit of quantification. CD4+ cell count >200 cells/mm^3 obtained within 90 days prior to study entry. At least one of the following cardiovascular risk factors (current diagnosis or receiving treatment, except where a time period is specified): Clinical atherosclerotic disease (symptomatic atherosclerotic lesions in any vessel) Subclinical atherosclerotic disease (coronary artery calcification [CAC] >10 or presence of non-obstructive plaques) DM or prediabetes (hemoglobin A1c [HbA1c] ≥5.7%) or impaired fasting glucose (documented fasting glucose of >100 mg/dL within 6 months prior to study entry) or insulin resistance (HOMA-IR ≥2.6) or any one of these laboratory values within 6 months prior to study entry Obesity (body mass index [BMI] ≥30 kg/m^2) or enlarged iliac waist circumference (>40 inches in males, >35 inches in females) History of hypertension or blood pressure ≥130/80 mmHg measured during screening Elevated LDL cholesterol (fasting LDL of >160 mg/dL; result from sample taken within 90 days prior to study entry can be used) Low HDL cholesterol (<40 mg/dL; result from sample taken within 90 days prior to study entry can be used) Smoking (any current tobacco smoking) Family history of premature CAD (first degree relative with CAD prior to age 55 for male relative and 65 for female relative; participant report is acceptable) hsCRP >2.0 mg/L within 90 days prior to study entry without an active infection or acute illness at the time the sample was obtained The following laboratory values obtained within 90 days prior to study entry: Absolute neutrophil count (ANC) >750/mm^3 Platelet count >100,000/mm^3 Aspartate aminotransferase (AST) (SGOT) ≤5x upper limit of normal (ULN) Alanine aminotransferase (ALT) (SGPT) ≤5x ULN Alkaline phosphatase ≤5x ULN Estimated glomerular filtration rate (GFR) ≥60 mL/min/1.73 m^2 as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation Pre-entry FDG-PET/CT imaging (within 60 days prior to study entry) that has been deemed: Interpretable as assessed by the central imaging core laboratory AND Without incidental findings that will preclude participation in the study at the discretion of the site investigator No plans to receive immunizations 7 days prior to the week 24 study visit. For study candidates of child-bearing potential, negative serum or urine pregnancy test within 90 days prior to study entry and prior to starting study treatment at study entry. Reproductive potential is defined as individuals who have reached menarche and individuals who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) ≥40 IU/mL or 24 consecutive months if an FSH is not available, or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy). If participating in sexual activity that could lead to pregnancy, willingness of person of childbearing potential to use two forms of contraception while receiving study medication and for 3 months after stopping study medication as required. Individuals ≥45 years of age. Ability and willingness of participant or legal guardian/representative to provide informed consent. Exclusion Criteria: Acute coronary syndrome, defined as myocardial infarction (MI) or unstable angina, within 90 days prior to study entry. A current diagnosis of latent or active tuberculosis (TB) infection, any prior untreated TB infection, inadequate treatment of active TB, or inadequate treatment of latent TB. Current diagnosis with other intracellular pathogens (Mycobacterium avium complex, Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans) within 90 days prior to study entry. Untreated hepatitis B virus (HBV) infection with detectable HBV DNA within 6 months prior to study entry. Current hepatitis C virus (HCV) infection (i.e., detectable HCV RNA within 6 months prior to study entry). Acute or clinically significant infection or illness requiring IV antibiotics or hospitalization within 90 days prior to study entry. History of cirrhosis with severe hepatic impairment and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding. Active malignancy, except squamous cell skin cancer. Hemoglobin A1c >8% within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs. Initiation of statin therapy or change in statin dose within 90 days prior to study entry. Current use of any of the statins at the doses indicated: Atorvastatin, >40 mg/day dose Rosuvastatin, ≥20 mg/day dose Anticipated addition of any lipid lowering medication during the course of the study. Concurrent use of drugs with potential drug-drug interactions with CVC within 90 days prior to study entry. Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation. Treatment within 30 days prior to study entry or anticipated treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons, cyclosporine, and tacrolimus). Immunization within 7 days prior to the pre-entry FDG-PET/CT imaging. History of radiation therapy. High radiation exposure within one year prior to entry, defined as having undergone more than two of any of the procedures below (includes having undergone the same procedure twice within one year prior to study entry): Coronary artery catheterization with or without percutaneous coronary intervention (PCI) Myocardial perfusion stress test Coronary CT angiography CT of the chest and abdomen Barium enema Currently pregnant, breastfeeding, or planning to become pregnant during the length of the study and three months after completing the study. Body weight >300 pounds or >136 kilograms. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Sites / Locations

  • University of California, Los Angeles CARE Center CRS (Site # 601)Recruiting
  • UCSD Antiviral Research Center CRS (Site # 701)
  • UCSF HIV/AIDS CRS (Site # 801)
  • Harbor University of California Los Angeles Center CRS (Site # 603)
  • Northwestern University CRS (Site # 2701)
  • Massachusetts General Hospital CRS (MGH CRS) (Site # 101)Recruiting
  • Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS (Site # 107)Recruiting
  • Weill Cornell Chelsea CRS (Site # 7804)Recruiting
  • Weill Cornell Uptown CRS (Site # 7803)
  • University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site # 31787)
  • Chapel Hill CRS (Site # 3201)
  • Cincinnati CRS (Site # 2401)
  • Case CRS (Site # 2501)Recruiting
  • Ohio State University CRS (Site # 2301)Recruiting
  • University of Pittsburgh CRS (Site # 1001)
  • Vanderbilt Therapeutics (VT) CRS (Site # 3652)
  • Houston AIDS Research Team CRS (Site # 31473)
  • University of Washington Positive Research CRS (Site # 1401)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CVC arm (Arm A)

Placebo for CVC arm (Arm B)

Arm Description

Participants with pre-existing ART regimen of EFV will take CVC 300 mg. Participants with all other pre-existing ARTs will take CVC 150 mg.

Participants with pre-existing ART regimen of EFV will take placebo for CVC 300 mg. Participants with all other pre-existing ARTs will take placebo for CVC 150 mg.

Outcomes

Primary Outcome Measures

Change in arterial most diseased segment (MDS) 18-FDG-PET target-to-background ratio (TBR) measured in the carotid arteries and aorta
To assess whether CVC treatment results in reduced arterial inflammation by comparing the changes in arterial target-to-background ratio (TBR) in the carotid arteries and aorta after treatment with CVC versus placebo.

Secondary Outcome Measures

Change in aortic TBR (and other TBRs)
Change in standardized uptake value (SUV) measured in the carotid arteries and aorta
Change in fasting glucose
Change in homeostasis model assessment-estimated insulin resistance (HOMA-IR)
Change in biomarker of inflammation
Biomarker: IL-6 (Interleukin-6)
Change in biomarker of immune activation
Biomarker: sCD14 (soluble CD14)

Full Information

First Posted
November 10, 2022
Last Updated
September 5, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05630885
Brief Title
A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
Official Title
A Limited-Center, Prospective, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
January 6, 2025 (Anticipated)
Study Completion Date
January 6, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study is being conducted to determine if cenicriviroc mesylate (CVC) will decrease vascular inflammation as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)/computed tomography (CT) imaging of the aorta.
Detailed Description
This is a double-blind, placebo-controlled phase II clinical trial comparing the intervention of CVC versus placebo for a duration of 24 weeks on arterial inflammation evaluated by FDG-PET/CT imaging. A total of 93 participants will be randomized 2:1 to the CVC arm (Arm A) or placebo for CVC arm (Arm B). Stratification by statin use at randomization will ensure even distribution of statin use between the treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1-infection
Keywords
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
At study entry, participants will be randomized 2:1 to oral CVC (Arm A) or oral placebo for CVC (Arm B) once a day. The study treatment will be added to the participants' pre-existing ARV regimens.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
93 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CVC arm (Arm A)
Arm Type
Experimental
Arm Description
Participants with pre-existing ART regimen of EFV will take CVC 300 mg. Participants with all other pre-existing ARTs will take CVC 150 mg.
Arm Title
Placebo for CVC arm (Arm B)
Arm Type
Placebo Comparator
Arm Description
Participants with pre-existing ART regimen of EFV will take placebo for CVC 300 mg. Participants with all other pre-existing ARTs will take placebo for CVC 150 mg.
Intervention Type
Drug
Intervention Name(s)
CVC 150 mg
Intervention Description
Administered as one 150-mg tablet by mouth once a day with food.
Intervention Type
Drug
Intervention Name(s)
CVC 300 mg
Intervention Description
Administered as two 150-mg tablets by mouth once a day with food.
Intervention Type
Other
Intervention Name(s)
Placebo for CVC 150 mg
Intervention Description
Administered as one 150-mg matching placebo tablets by mouth once a day with food.
Intervention Type
Other
Intervention Name(s)
Placebo for CVC 300 mg
Intervention Description
Administered as two 150-mg matching placebo tablets by mouth once a day with food.
Primary Outcome Measure Information:
Title
Change in arterial most diseased segment (MDS) 18-FDG-PET target-to-background ratio (TBR) measured in the carotid arteries and aorta
Description
To assess whether CVC treatment results in reduced arterial inflammation by comparing the changes in arterial target-to-background ratio (TBR) in the carotid arteries and aorta after treatment with CVC versus placebo.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change in aortic TBR (and other TBRs)
Time Frame
Baseline, Week 24
Title
Change in standardized uptake value (SUV) measured in the carotid arteries and aorta
Time Frame
Baseline, Week 24
Title
Change in fasting glucose
Time Frame
Baseline, Week 24
Title
Change in homeostasis model assessment-estimated insulin resistance (HOMA-IR)
Time Frame
Baseline, Week 24
Title
Change in biomarker of inflammation
Description
Biomarker: IL-6 (Interleukin-6)
Time Frame
Baseline, Week 24
Title
Change in biomarker of immune activation
Description
Biomarker: sCD14 (soluble CD14)
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented HIV-1 infection. Currently on a stable, continuous NNRTI-based or unboosted INSTI-based ART regimen for ≥48 weeks prior to study entry with no ART interruption longer than 7 consecutive days and with no plans to change ART during the course of the study. Screening HIV-1 RNA level below the limit of quantification. All HIV-1 RNA levels within 48 weeks prior to study entry below the limit of quantification. CD4+ cell count >200 cells/mm^3 obtained within 90 days prior to study entry. At least one of the following cardiovascular risk factors (current diagnosis or receiving treatment, except where a time period is specified): Clinical atherosclerotic disease (symptomatic atherosclerotic lesions in any vessel) Subclinical atherosclerotic disease (coronary artery calcification [CAC] >10 or presence of non-obstructive plaques) DM or prediabetes (hemoglobin A1c [HbA1c] ≥5.7%) or impaired fasting glucose (documented fasting glucose of >100 mg/dL within 6 months prior to study entry) or insulin resistance (HOMA-IR ≥2.6) or any one of these laboratory values within 6 months prior to study entry Obesity (body mass index [BMI] ≥30 kg/m^2) or enlarged iliac waist circumference (>40 inches in males, >35 inches in females) History of hypertension or blood pressure ≥130/80 mmHg measured during screening Elevated LDL cholesterol (fasting LDL of >160 mg/dL; result from sample taken within 90 days prior to study entry can be used) Low HDL cholesterol (<40 mg/dL; result from sample taken within 90 days prior to study entry can be used) Smoking (any current tobacco smoking) Family history of premature CAD (first degree relative with CAD prior to age 55 for male relative and 65 for female relative; participant report is acceptable) hsCRP >2.0 mg/L within 90 days prior to study entry without an active infection or acute illness at the time the sample was obtained The following laboratory values obtained within 90 days prior to study entry: Absolute neutrophil count (ANC) >750/mm^3 Platelet count >100,000/mm^3 Aspartate aminotransferase (AST) (SGOT) ≤5x upper limit of normal (ULN) Alanine aminotransferase (ALT) (SGPT) ≤5x ULN Alkaline phosphatase ≤5x ULN Estimated glomerular filtration rate (GFR) ≥60 mL/min/1.73 m^2 as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation Pre-entry FDG-PET/CT imaging (within 60 days prior to study entry) that has been deemed: Interpretable as assessed by the central imaging core laboratory AND Without incidental findings that will preclude participation in the study at the discretion of the site investigator No plans to receive immunizations 7 days prior to the week 24 study visit. For study candidates of child-bearing potential, negative serum or urine pregnancy test within 90 days prior to study entry and prior to starting study treatment at study entry. Reproductive potential is defined as individuals who have reached menarche and individuals who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) ≥40 IU/mL or 24 consecutive months if an FSH is not available, or have not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy). If participating in sexual activity that could lead to pregnancy, willingness of person of childbearing potential to use two forms of contraception while receiving study medication and for 3 months after stopping study medication as required. Individuals ≥45 years of age. Ability and willingness of participant or legal guardian/representative to provide informed consent. Exclusion Criteria: Acute coronary syndrome, defined as myocardial infarction (MI) or unstable angina, within 90 days prior to study entry. A current diagnosis of latent or active tuberculosis (TB) infection, any prior untreated TB infection, inadequate treatment of active TB, or inadequate treatment of latent TB. Current diagnosis with other intracellular pathogens (Mycobacterium avium complex, Listeria monocytogenes, Toxoplasma gondii, and Cryptococcus neoformans) within 90 days prior to study entry. Untreated hepatitis B virus (HBV) infection with detectable HBV DNA within 6 months prior to study entry. Current hepatitis C virus (HCV) infection (i.e., detectable HCV RNA within 6 months prior to study entry). Acute or clinically significant infection or illness requiring IV antibiotics or hospitalization within 90 days prior to study entry. History of cirrhosis with severe hepatic impairment and/or hepatic decompensation including ascites, hepatic encephalopathy, or variceal bleeding. Active malignancy, except squamous cell skin cancer. Hemoglobin A1c >8% within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent, or at any network-approved non-US laboratory or clinic that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs. Initiation of statin therapy or change in statin dose within 90 days prior to study entry. Current use of any of the statins at the doses indicated: Atorvastatin, >40 mg/day dose Rosuvastatin, ≥20 mg/day dose Anticipated addition of any lipid lowering medication during the course of the study. Concurrent use of drugs with potential drug-drug interactions with CVC within 90 days prior to study entry. Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation. Treatment within 30 days prior to study entry or anticipated treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons, cyclosporine, and tacrolimus). Immunization within 7 days prior to the pre-entry FDG-PET/CT imaging. History of radiation therapy. High radiation exposure within one year prior to entry, defined as having undergone more than two of any of the procedures below (includes having undergone the same procedure twice within one year prior to study entry): Coronary artery catheterization with or without percutaneous coronary intervention (PCI) Myocardial perfusion stress test Coronary CT angiography CT of the chest and abdomen Barium enema Currently pregnant, breastfeeding, or planning to become pregnant during the length of the study and three months after completing the study. Body weight >300 pounds or >136 kilograms. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Lo, MD, MMSc
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Los Angeles CARE Center CRS (Site # 601)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael J Landovitz, MD
Phone
310-825-3782
Email
rlandovitz@mednet.ucla.edu
Facility Name
UCSD Antiviral Research Center CRS (Site # 701)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan J Little, MD
Phone
619-543-8080
Email
slittle@ucsd.edu
Facility Name
UCSF HIV/AIDS CRS (Site # 801)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvira Gomez
Phone
415-476-4082
Ext
106
Email
elvira.gomez@ucsf.edu
Facility Name
Harbor University of California Los Angeles Center CRS (Site # 603)
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric S Daar, MD
Phone
424-201-3000
Ext
7317
Email
edaar@lundquist.org
Facility Name
Northwestern University CRS (Site # 2701)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babafemi Taiwo, MD
Phone
312-695-4994
Email
b-taiwo@northwestern.edu
Facility Name
Massachusetts General Hospital CRS (MGH CRS) (Site # 101)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Sbrolla, RN, BSN, ACRN
Phone
1-617-726-5598
Email
asbrolla@mgh.harvard.edu
Facility Name
Brigham and Women's Hospital Therapeutics (BWH TCRS) CRS (Site # 107)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Manne, MD
Phone
617-726-0198
Email
jmanne@partners.org
Facility Name
Weill Cornell Chelsea CRS (Site # 7804)
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Marks, MD
Phone
212-746-4177
Email
markskr@med.cornell.edu
Facility Name
Weill Cornell Uptown CRS (Site # 7803)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marshall J Glesby, MD
Phone
212-746-7134
Email
mag2005@med.cornell.edu
Facility Name
University of Rochester Adult HIV Therapeutic Strategies Network CRS (Site # 31787)
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonal S Munsiff, MD
Phone
585-276-7199
Email
Sonal_Munsiff@URMC.Rochester.edu
Facility Name
Chapel Hill CRS (Site # 3201)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David A Wohl, MD
Phone
919-843-2723
Email
wohl@med.unc.edu
Facility Name
Cincinnati CRS (Site # 2401)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0405
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl J Fichtenbaum, MD
Phone
513-584-6361
Email
carl.fichtenbaum@uc.edu
Facility Name
Case CRS (Site # 2501)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Jacobson, MD
Phone
215-707-6451
Email
jxj573@case.edu
Facility Name
Ohio State University CRS (Site # 2301)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1282
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan L Koletar, MD
Phone
614-293-5667
Email
susan.koletar@osumc.edu
Facility Name
University of Pittsburgh CRS (Site # 1001)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Riddler, MD
Phone
412-383-1741
Email
riddler@pitt.edu
Facility Name
Vanderbilt Therapeutics (VT) CRS (Site # 3652)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David W Haas, MD
Phone
615-936-8594
Email
david.haas@vumc.org
Facility Name
Houston AIDS Research Team CRS (Site # 31473)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Arduino
Phone
713-500-6731
Email
roberto.c.arduino@uth.tmc.edu
Facility Name
University of Washington Positive Research CRS (Site # 1401)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel B Ignacio, MD
Phone
206-744-4876
Email
rbi13@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie results in the publication, after deidentification.
IPD Sharing Time Frame
Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
IPD Sharing Access Criteria
With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group. For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.

Learn more about this trial

A Study to Evaluate the Effects of Cenicriviroc Mesylate on Arterial Inflammation in People Living With HIV

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