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A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes. (ELICIT)

Primary Purpose

HIV Infections, Cytomegalovirus, CMV

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Letermovir 240 MG Oral Tablet
Letermovir 480 MG Oral Tablet
Combination ART
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 Infections

Eligibility Criteria

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

Inclusion Criteria:

  1. HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

    • NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies.

    WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. More information on this criterion can be found in the protocol.

  2. Currently on continuous combination ART (antiretroviral therapy) for ≥48 weeks prior to study entry. This is defined as continuous ART for the 48-week period prior to study entry with no ART interruption longer than 7 consecutive days.
  3. Screening plasma HIV-1 RNA <40 copies/mL within 90 days prior to study entry using a FDA-approved assay with a quantification limit of 40 copies/mL or lower performed by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
  4. HIV-1 RNA level <40 copies/mL for at least 48 weeks prior to study entry performed by any US laboratory that has a CLIA certification or its equivalent.

    • NOTE: Single determinations that are between the assay quantification limit and 500 copies/mL (i.e., "blips") are allowed as long as the preceding and subsequent determinations are below the level of quantification. The screening value may serve as the subsequent undetectable value following a blip.
  5. CD4⁺/CD8⁺ cell count obtained within 90 days prior to study entry at any US laboratory that has a CLIA certification or its equivalent.
  6. Positive CMV IgG serology, at any time prior to study entry using a FDA-approved assay at any US laboratory that has a CLIA certification or its equivalent.

    • NOTE: If a prior positive CMV IgG serology test is confirmed in the medical record, a repeat CMV IgG test is not required at screening.
  7. The following laboratory values obtained within 90 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent:

    • Hemoglobin >9.0 g/dL
    • Platelet count >75,000/mm³
    • Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase ≤3 x ULN (upper limit of normal)
    • Total bilirubin ≤2.5 x ULN

      • NOTE: If an individual is taking atazanavir-containing regimen at the time of screening, a total bilirubin of ≤5 x ULN is acceptable.
    • Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73m² or creatinine clearance (CrCl) >30 mL/min using the Cockcroft-Gault, EPI-GFR or MDRD equations located on the DMC website.
  8. For individuals assigned female sex at birth and of reproductive potential, negative serum or urine pregnancy test within 24 hours prior to study entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or a CLIA Certificate of Waiver for those performing a point of care (POC)/CLIA-waived test. (Urine test must have a sensitivity of <25 mlU/mL).

    • NOTE: Persons of female sex assigned at birth and of reproductive potential are defined as having reached menarche and have not been post-menopausal for at least 24 consecutive months (i.e. have had menses within the preceding 24 months), and have not undergone testosterone therapy for gender alignment or surgical sterilization such as hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy. An individual's report is considered acceptable documentation or reproductive status.
  9. All participants that are participating in sexual activity that could lead to pregnancy must agree to use contraception throughout the study. At least one of the following must be used throughout the study:

    • Diaphragm or cervical cap with spermicide
    • Intrauterine device (IUD)
    • Hormone-based contraceptive
    • Condoms with or without a spermicide

      • NOTE A: Individuals who are not of reproductive potential are not required to use contraception.
      • NOTE B: Sperm-producing participants should refrain from donating sperm during the treatment period and for at least 90 days after the last dose of study treatment.
  10. Persons age greater than or equal to 40 years.
  11. Ability and willingness of individual or legal guardian/representative to provide informed consent.

Exclusion Criteria:

  1. Change in the ART regimen within 12 weeks prior to study entry or intended modification of ART during the study.

    • NOTE: Modifications in the dosage or frequency (i.e. twice a day [bid] to once a day [qd]) of individual antiretroviral (ARV) drugs during the 12 weeks prior to study entry are permitted. In addition, the change in formulation (e.g. from standard formulation to fixed-dose combination) is allowed within 12 weeks prior to study entry. A within class single drug substitution (e.g. switch from atazanavir to darunavir, or tenofovir disoproxil fumarate to tenofovir alafenamide) is allowed within 12 weeks prior to study entry. A switch to any other nucleoside reverse transcriptase inhibitor (NRTI) from abacavir (or vice versa) is not permissible. No other changes in ART within the 12 weeks prior to study entry are permitted.
  2. Use of any of the following ARV drugs in current regimen: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, and once-daily dosing of raltegravir (bid dosing of raltegravir is acceptable).
  3. Two or more HIV-1 RNA determinations >200 copies/mL within 48 weeks prior to study entry.
  4. Any febrile illness (>101°F) within 30 days prior to study entry.
  5. Use of drugs with anti-CMV activity within 90 days prior to study entry, with the exception of standard dose valacyclovir and acyclovir. See the protocol for more information.
  6. Immunosuppressive or immunomodulatory drug use, with the exception of topical, inhaled, and intranasal corticosteroids within 90 days prior to study entry. See the protocol for more information.
  7. Concomitant use of prohibited medications. See the protocol for more information.
  8. Persons who are breastfeeding, pregnant or planning to become pregnant during the study.
  9. Participating in a study where co-enrollment is not allowed.
  10. Receipt of any vaccination within 14 days prior to study entry.
  11. Presence on screening ECG or a known history of atrial tachycardia (other than sinus tachycardia). Ventricular tachycardia is also an exclusion criterion.
  12. History of cardiomyopathy or congenital heart disease or evidence of advanced conduction system disease including second degree heart block Mobitz type II, third degree heart block, AV dissociation or ECG findings that may be suggestive of predisposition to arrhythmia (i.e. delta wave).
  13. Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation.
  14. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  15. Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry.
  16. Known chronic active hepatitis B virus infection within the last 24 weeks prior to study entry.

    • NOTE: Active is defined as hepatitis B surface antigen (HBsAg) positive and hepatitis B DNA (HBV DNA) positive. Persons with HBV DNA below level of quantification (BLQ) for >24 weeks prior to study entry are eligible.
  17. Known chronic active hepatitis C within the last 24 weeks prior to study entry.

    • NOTE: Active is defined as a detectable plasma hepatitis C virus (HCV) RNA level. Persons with HCV RNA BLQ for >24 weeks prior to study entry are eligible.
  18. Presence of history of conditions that could account for impaired neuropsychological performance (if present), including head injury with prolonged (>1 hour) loss of consciousness, central nervous system infection (e.g. encephalitis), severe learning disability, psychosis, and/or active drug or alcohol use, or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  19. History of multi-class HIV drug resistance or intolerance, such that in the opinion of the investigator, an alternative fully active antiretroviral regimen cannot be constructed should the participant experience loss of viral suppression on their current regimen during the study.

Sites / Locations

  • Alabama CRS
  • UCLA CARE Center CRS
  • UCSD Antiviral Research Center CRS (Site 701)
  • UCSF HIV/AIDS CRS (Site 801)Recruiting
  • University of Colorado Hospital CRSRecruiting
  • Northwestern University CRS
  • Massachusetts General Hospital CRS (MGH CRS)
  • Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
  • Washington University Therapeutics (WT) CRS
  • Weill Cornell Chelsea CRS (7804)
  • Weill Cornell Uptown CRS (7803)
  • University of Rochester Adult HIV Therapeutic Strategies Network CRSRecruiting
  • Cincinnati Clinical Research Site
  • Ohio State University CRS
  • Penn Therapeutics, CRS
  • University of Pittsburgh CRS
  • Vanderbilt Therapeutics (VT) CRS
  • Houston AIDS Research Team CRS
  • University of Washington AIDS CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm A: Letermovir

Arm B: No anti-CMV treatment

Arm Description

Letermovir 480 mg will be administered by one of the following strategies: Letermovir 240 mg tablets administered orally as two tablets once daily with or without food. Letermovir 480 mg tablets administered orally as one tablet once daily with or without food. Participants will be able to switch administration strategy during treatment duration based on availability of study supply.

Outcomes

Primary Outcome Measures

Change from the average at baseline (entry and treatment initiation visits) in sTNFRII at week 48
sTNFRII (plasma soluble receptor for tumor necrosis factor type II) analyzed using ELISA.

Secondary Outcome Measures

Incidence of Grade ≥3 AEs
Incidence of Grade ≥3 adverse events (AEs) after initiation of study treatment. AEs defined in version 2.0 of the DAIDS EAE Manual.
Mucosal CMV DNA levels
Mucosal samples are from throat wash, seminal plasma and cervicovaginal swabs, Measured by PCR (polymerase chain reaction) analysis.
Plasma CMV DNA levels
Measured by PCR (polymerase chain reaction) analysis.
Change from baseline in sCD163 at week 8
Measured by serum analysis using ELISA.
Change from baseline in sCD163 at week 46
Measured by serum analysis using ELISA.
Change from baseline in sCD163 at week 48
Measured by serum analysis using ELISA.
Change from baseline in sCD163 at week 52
Measured by serum analysis using ELISA.
Change from baseline in sCD163 at week 60
Measured by serum analysis using ELISA
Change from baseline in sTNFRII at week 8
Measured using ELISA.
Change from baseline in sTNFRII at week 52
Measured using ELISA.
Change from baseline in sTNFRII at week 60
Measured using ELISA.

Full Information

First Posted
April 7, 2021
Last Updated
April 25, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04840199
Brief Title
A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.
Acronym
ELICIT
Official Title
Randomized, Controlled Trial to Evaluate the Anti-inflammatory Efficacy of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
February 16, 2025 (Anticipated)
Study Completion Date
May 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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

5. Study Description

Brief Summary
This is an open-label, controlled study, conducted at US sites to evaluate the anti-inflammatory effectiveness of the study drug letermovir in adults with HIV and asymptomatic cytomegalovirus (CMV) who are on antiretroviral therapy (ART)-mediated suppression. Participants will be randomly assigned to receive either letermovir once daily or no anti-CMV treatment, for 48 weeks.
Detailed Description
This is a phase 2, randomized, open-label, controlled, multicenter trial to evaluate the anti-inflammatory efficacy of letermovir, administered once daily for 48 weeks in adults with HIV and asymptomatic CMV, who are on ART-mediated suppression. Participants will be randomized 1:1 to receive either letermovir or no anti-CMV treatment. A futility analysis will be performed after the first 40 participants to initiate study treatment reach their 8-week study visit. Study enrollment will be paused after the 40th participant starts treatment until the results of the futility analysis have been considered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Cytomegalovirus, CMV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Letermovir
Arm Type
Experimental
Arm Description
Letermovir 480 mg will be administered by one of the following strategies: Letermovir 240 mg tablets administered orally as two tablets once daily with or without food. Letermovir 480 mg tablets administered orally as one tablet once daily with or without food. Participants will be able to switch administration strategy during treatment duration based on availability of study supply.
Arm Title
Arm B: No anti-CMV treatment
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Letermovir 240 MG Oral Tablet
Other Intervention Name(s)
PREVYMIS
Intervention Description
240 mg tablets. Administered orally as two tablets once daily with or without food.
Intervention Type
Drug
Intervention Name(s)
Letermovir 480 MG Oral Tablet
Other Intervention Name(s)
PREVYMIS
Intervention Description
480 mg tablet. Administered orally as one tablet once daily with or without food.
Intervention Type
Drug
Intervention Name(s)
Combination ART
Intervention Description
ART (antiretroviral therapy) medications will be prescribed by participants' health care providers. ARV medications will not be provided by the study.
Primary Outcome Measure Information:
Title
Change from the average at baseline (entry and treatment initiation visits) in sTNFRII at week 48
Description
sTNFRII (plasma soluble receptor for tumor necrosis factor type II) analyzed using ELISA.
Time Frame
Baseline and weeks 46 and 48.
Secondary Outcome Measure Information:
Title
Incidence of Grade ≥3 AEs
Description
Incidence of Grade ≥3 adverse events (AEs) after initiation of study treatment. AEs defined in version 2.0 of the DAIDS EAE Manual.
Time Frame
Baseline and week 60
Title
Mucosal CMV DNA levels
Description
Mucosal samples are from throat wash, seminal plasma and cervicovaginal swabs, Measured by PCR (polymerase chain reaction) analysis.
Time Frame
Measured through week 60
Title
Plasma CMV DNA levels
Description
Measured by PCR (polymerase chain reaction) analysis.
Time Frame
Measured through week 60
Title
Change from baseline in sCD163 at week 8
Description
Measured by serum analysis using ELISA.
Time Frame
Baseline and week 8
Title
Change from baseline in sCD163 at week 46
Description
Measured by serum analysis using ELISA.
Time Frame
Baseline and week 46
Title
Change from baseline in sCD163 at week 48
Description
Measured by serum analysis using ELISA.
Time Frame
Baseline and week 48
Title
Change from baseline in sCD163 at week 52
Description
Measured by serum analysis using ELISA.
Time Frame
Baseline and week 52
Title
Change from baseline in sCD163 at week 60
Description
Measured by serum analysis using ELISA
Time Frame
Baseline and week 60
Title
Change from baseline in sTNFRII at week 8
Description
Measured using ELISA.
Time Frame
Baseline and week 8
Title
Change from baseline in sTNFRII at week 52
Description
Measured using ELISA.
Time Frame
Baseline and week 52
Title
Change from baseline in sTNFRII at week 60
Description
Measured using ELISA.
Time Frame
Baseline and week 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load. NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies. WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. More information on this criterion can be found in the protocol. Currently on continuous combination ART (antiretroviral therapy) for ≥48 weeks prior to study entry. This is defined as continuous ART for the 48-week period prior to study entry with no ART interruption longer than 7 consecutive days. Screening plasma HIV-1 RNA <40 copies/mL within 90 days prior to study entry using a FDA-approved assay with a quantification limit of 40 copies/mL or lower performed by any US laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent. HIV-1 RNA level <40 copies/mL for at least 48 weeks prior to study entry performed by any US laboratory that has a CLIA certification or its equivalent. NOTE: Single determinations that are between the assay quantification limit and 500 copies/mL (i.e., "blips") are allowed as long as the preceding and subsequent determinations are below the level of quantification. The screening value may serve as the subsequent undetectable value following a blip. CD4⁺/CD8⁺ cell count obtained within 90 days prior to study entry at any US laboratory that has a CLIA certification or its equivalent. Positive CMV IgG serology, at any time prior to study entry using a FDA-approved assay at any US laboratory that has a CLIA certification or its equivalent. NOTE: If a prior positive CMV IgG serology test is confirmed in the medical record, a repeat CMV IgG test is not required at screening. The following laboratory values obtained within 90 days prior to study entry by any US laboratory that has a CLIA certification or its equivalent: Hemoglobin >9.0 g/dL Platelet count >75,000/mm³ Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT), and alkaline phosphatase ≤3 x ULN (upper limit of normal) Total bilirubin ≤2.5 x ULN NOTE: If an individual is taking atazanavir-containing regimen at the time of screening, a total bilirubin of ≤5 x ULN is acceptable. Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73m² or creatinine clearance (CrCl) >30 mL/min using the Cockcroft-Gault, EPI-GFR or MDRD equations located on the DMC website. For individuals assigned female sex at birth and of reproductive potential, negative serum or urine pregnancy test within 24 hours prior to study entry by any US clinic or laboratory that has a CLIA certification or its equivalent, or a CLIA Certificate of Waiver for those performing a point of care (POC)/CLIA-waived test. (Urine test must have a sensitivity of <25 mlU/mL). NOTE: Persons of female sex assigned at birth and of reproductive potential are defined as having reached menarche and have not been post-menopausal for at least 24 consecutive months (i.e. have had menses within the preceding 24 months), and have not undergone testosterone therapy for gender alignment or surgical sterilization such as hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy. An individual's report is considered acceptable documentation or reproductive status. All participants that are participating in sexual activity that could lead to pregnancy must agree to use contraception throughout the study. At least one of the following must be used throughout the study: Diaphragm or cervical cap with spermicide Intrauterine device (IUD) Hormone-based contraceptive Condoms with or without a spermicide NOTE A: Individuals who are not of reproductive potential are not required to use contraception. NOTE B: Sperm-producing participants should refrain from donating sperm during the treatment period and for at least 90 days after the last dose of study treatment. Persons age greater than or equal to 40 years. Ability and willingness of individual or legal guardian/representative to provide informed consent. Exclusion Criteria: Change in the ART regimen within 12 weeks prior to study entry or intended modification of ART during the study. NOTE: Modifications in the dosage or frequency (i.e. twice a day [bid] to once a day [qd]) of individual antiretroviral (ARV) drugs during the 12 weeks prior to study entry are permitted. In addition, the change in formulation (e.g. from standard formulation to fixed-dose combination) is allowed within 12 weeks prior to study entry. A within class single drug substitution (e.g. switch from atazanavir to darunavir, or tenofovir disoproxil fumarate to tenofovir alafenamide) is allowed within 12 weeks prior to study entry. A switch to any other nucleoside reverse transcriptase inhibitor (NRTI) from abacavir (or vice versa) is not permissible. No other changes in ART within the 12 weeks prior to study entry are permitted. Use of any of the following ARV drugs in current regimen: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, and once-daily dosing of raltegravir (bid dosing of raltegravir is acceptable). Two or more HIV-1 RNA determinations >200 copies/mL within 48 weeks prior to study entry. Any febrile illness (>101°F) within 30 days prior to study entry. Use of drugs with anti-CMV activity within 90 days prior to study entry, with the exception of standard dose valacyclovir and acyclovir. See the protocol for more information. Immunosuppressive or immunomodulatory drug use, with the exception of topical, inhaled, and intranasal corticosteroids within 90 days prior to study entry. See the protocol for more information. Concomitant use of prohibited medications. See the protocol for more information. Persons who are breastfeeding, pregnant or planning to become pregnant during the study. Participating in a study where co-enrollment is not allowed. Receipt of any vaccination within 14 days prior to study entry. Presence on screening ECG or a known history of atrial tachycardia (other than sinus tachycardia). Ventricular tachycardia is also an exclusion criterion. History of cardiomyopathy or congenital heart disease or evidence of advanced conduction system disease including second degree heart block Mobitz type II, third degree heart block, AV dissociation or ECG findings that may be suggestive of predisposition to arrhythmia (i.e. delta wave). Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry. Known chronic active hepatitis B virus infection within the last 24 weeks prior to study entry. NOTE: Active is defined as hepatitis B surface antigen (HBsAg) positive and hepatitis B DNA (HBV DNA) positive. Persons with HBV DNA below level of quantification (BLQ) for >24 weeks prior to study entry are eligible. Known chronic active hepatitis C within the last 24 weeks prior to study entry. NOTE: Active is defined as a detectable plasma hepatitis C virus (HCV) RNA level. Persons with HCV RNA BLQ for >24 weeks prior to study entry are eligible. Presence of history of conditions that could account for impaired neuropsychological performance (if present), including head injury with prolonged (>1 hour) loss of consciousness, central nervous system infection (e.g. encephalitis), severe learning disability, psychosis, and/or active drug or alcohol use, or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. History of multi-class HIV drug resistance or intolerance, such that in the opinion of the investigator, an alternative fully active antiretroviral regimen cannot be constructed should the participant experience loss of viral suppression on their current regimen during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hunt, MD
Organizational Affiliation
University of California, San Francisco, HIV/AIDS CRS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara Gianella, MD
Organizational Affiliation
University of California, San Diego, AntiViral Research Center CRS
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faye Heard, MPH
Phone
205-996-4405
Email
fhoward@uabmc.edu
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035-4709
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleen Khodabakhshian
Phone
310-557-2273
Ext
20891
Email
akhodabakhshian@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
Steven Hendrickx, R.N.
Phone
619-543-6968
Email
smhendrickx@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
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
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Fiorillo, M.S.P.H.
Phone
303-724-5931
Email
suzanne.fiorillo@cuanschutz.edu
Facility Name
Northwestern University CRS
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
Baiba Berzins, M.P.H.
Phone
312-695-5012
Email
Baiba@northwestern.edu
Facility Name
Massachusetts General Hospital CRS (MGH CRS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Sbrolla, R.N., B.S.N., A.C.R.N.
Phone
1-617-726-5598
Email
asbrolla@mgh.harvard.edu
Facility Name
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Keenan, RN
Phone
617-732-5635
Email
CKeenan@bwh.harvard.edu
Facility Name
Washington University Therapeutics (WT) CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Klebert
Phone
314-747-1098
Email
mklebert@wustl.edu
Facility Name
Weill Cornell Chelsea CRS (7804)
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Fry, MSN
Phone
212-746-7198
Email
ref2007@med.cornell.edu
Facility Name
Weill Cornell Uptown CRS (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
Jonathan Berardi, APRN
Phone
212-746-7864
Email
jlb4002@med.cornell.edu
Facility Name
University of Rochester Adult HIV Therapeutic Strategies Network CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Hulse
Phone
585-275-0529
Email
susan_hulse@urmc.rochester.edu
Facility Name
Cincinnati Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Kohrs, RN
Phone
513-584-6383
Email
kohrssd@ucmail.uc.edu
Facility Name
Ohio State University CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Summers, MPH
Phone
614-293-8529
Email
Lindsay.Summers@osumc.edu
Facility Name
Penn Therapeutics, CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Doyle, MPH, CCRC
Phone
215-615-2316
Email
Jamie.Doyle1@pennmedicine.upenn.edu
Facility Name
University of Pittsburgh CRS
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
Dawn Weinman
Phone
412-383-1748
Email
drw38@pitt.edu
Facility Name
Vanderbilt Therapeutics (VT) CRS
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
Beverly Woodward, MSN BN
Phone
615-936-8516
Email
beverly.o.woodward@vumc.org
Facility Name
Houston AIDS Research Team CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Martinez
Phone
713-500-6718
Email
Maria.L.Martinez@uth.tmc.edu
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-9929
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Jonsson, EMBA
Phone
206-744-8886
Email
cjonsson@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 de-identification.
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 with data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://submit.mis.s-3.net/. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.
IPD Sharing URL
https://submit.mis.s-3.net/

Learn more about this trial

A Study to Evaluate the Anti-inflammatory Effects of Letermovir (Prevymis) in Adults With Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive Antiretroviral Therapy, Plus Its Effect on Chronic Inflammation, HIV Persistence and Other Clinical Outcomes.

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