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Study of Tecovirimat for Human Monkeypox Virus (STOMP)

Primary Purpose

Monkeypox, MPOX

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tecovirimat Oral Capsule
Placebo
Tecovirimat Oral Capsule (Open Label)
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 Monkeypox focused on measuring HMPXV

Eligibility Criteria

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

Inclusion Criteria (All participants; Arms A, B, and C):

  1. Laboratory-confirmed or presumptive HMPXV infection.
  2. HMPXV illness of <14 days duration immediately prior to study entry.
  3. At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers.
  4. Non-pregnant people of reproductive potential must agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation.

Additional Inclusion Criteria for Arms A and B:

1. Age ≥18 years at the time of study entry

Additional Inclusion Criteria for Arm C; Participants who meet the above entry criteria who also meet any of the following criteria will be registered to Arm C:

  1. Participants age <18 years at the time of study entry
  2. Those with severe HMPXV disease

Those with or without severe disease and with one or more of the following will also be enrolled into Arm C:

  • Severe immunosuppression
  • Skin conditions placing the person at higher risk for disseminated infection

Exclusion Criteria (All participants; Arms A, B, and C):

  1. Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism.
  2. Planned initiation of intramuscular cabotegravir/rilpivirine during study drug administration or for two weeks following completion of study drug administration. Participants who are stable on long-acting intramuscular cabotegravir/rilpivirine may enroll.
  3. Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study.
  4. Participants who require intravenous dosing of tecovirimat.

Sites / Locations

  • Alabama CRSRecruiting
  • Kaiser Permanente Los Angeles Medical CenterRecruiting
  • Los Angeles LGBT Center CRSRecruiting
  • Usc La Nichd CrsRecruiting
  • UCLA CARE Center CRSRecruiting
  • David Geffen School of Medicine at UCLA NICHD CRSRecruiting
  • Easy Bay AIDS Center CRS City: Oakland
  • University of California, Davis CRSRecruiting
  • UCSD Antiviral Research Center CRSRecruiting
  • University of California, San Francisco HIV/AIDS CRSRecruiting
  • Harbor University of California Los Angeles CenterRecruiting
  • University of Colorado Denver NICHD CRSRecruiting
  • University of Colorado Hospital CRSRecruiting
  • Denver Public Health CRSRecruiting
  • Yale University School of MedicineRecruiting
  • University of FloridaRecruiting
  • University of Florida Jacksonville NICHD CRSRecruiting
  • University of Miami / Jackson Memorial HospitalRecruiting
  • University of Miami/Pediatric Perinatal HIV NICHD CRSRecruiting
  • Univ. of South Florida (USF) College of Medicine ARecruiting
  • The Ponce de Leon Center CRSRecruiting
  • Ann & Robert H Lurie Children's Hospital of ChicagoRecruiting
  • Northwestern UniversityRecruiting
  • Rush University Cook County Hospital Chicago NICHD CRSRecruiting
  • Rush University CRSRecruiting
  • Johns Hopkins University CRSRecruiting
  • Massachusetts General Hospital CRS (MGH CRS)Recruiting
  • Brigham and Women's Hospital TherapeuticsRecruiting
  • Henry Ford Hospital CRSRecruiting
  • Washington University Therapeutics (WT) CRSRecruiting
  • University of Nebraska Medical Center (Specialty Care Center)Recruiting
  • New Jersey Medical School Clinical Research CenterRecruiting
  • Jacobi Medical Center Bronx NICHD CRSRecruiting
  • Weill Cornell Chelsea CRSRecruiting
  • Mount Sinai West Samuels CRSRecruiting
  • Harlem Prevention CenterRecruiting
  • Columbia Physicians & Surgeons (P&S) CRSRecruiting
  • Weill Cornell Uptown CRSRecruiting
  • Bronx-Lebanon Hospital Center NICHD CRSRecruiting
  • Infectious Disease Clinical and Translational ResearchRecruiting
  • University of Rochester Adult HIV TherapeuticRecruiting
  • SUNY Stony Brook NICHD CRSRecruiting
  • Duke University Medical Center CRS
  • Wake Forest Baptist Medical Center CRSRecruiting
  • Cincinnati CRSRecruiting
  • Case Western Reserve University CTURecruiting
  • Ohio State University CRSRecruiting
  • Penn Therapeutics CRSRecruiting
  • University of Pittsburgh CRSRecruiting
  • St. Jude Children's Research Hospital ATN CRSRecruiting
  • Vanderbilt Therapeutics CRSRecruiting
  • Trinity Health and Wellness Center CRSRecruiting
  • North Texas Infectious Disease ConsultantsRecruiting
  • UT Southwestern Infectious Disease Research UnitRecruiting
  • Baylor College of Medicine / Texas Children's Hospital NICHD CRSRecruiting
  • Houston AIDS Research Team (HART) CRSRecruiting
  • University of Texas, San AntonioRecruiting
  • Virginia Commonwealth University Division of Infectious DiseasesRecruiting
  • University of Washington Positive ResearchRecruiting
  • Fundacion Huesped CRS
  • Hospital Nossa Senhora da Conceicao CRS
  • Centro de Pesquisas Clínicas IC-HCFMUSP CRS
  • Centro de Referencia e Treinamento DST/AIDS CRS
  • University of Sao Paolo
  • National Center for Global Health and Medicine
  • Nutricion Mexico CRSRecruiting
  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) CRS
  • Barranco CRS
  • San Miguel CRS
  • Socios En Salud Sucursal Peru
  • Via Libre CRS
  • IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRSRecruiting
  • Puerto Rico AIDS Clinical Trials Unit CRSRecruiting
  • Soweto CRS
  • University of the Witwatersrand Helen Joseph (WITS HJH)
  • Thai Red Cross AIDS Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Outcomes

Primary Outcome Measures

Time to clinical resolution, defined as the first day on which all skin lesions are scabbed, desquamated or healed, and visible mucosal lesions are healed

Secondary Outcome Measures

Pain assessed by 11-point numerical rating scale for pain
Time to development of severe HMPXV in those without severe HMPXV at baseline
Level of HMPXV in blood
Level of HMPXV in skin lesions
Level of HMPXV in oropharynx
Level of HMPXV in rectum
Level of HMPXV in genital secretions
Time to complete lesion healing defined as all lesions being re-epithelialized
Participant-reported adherence
Participant-reported quality-of-life as measured by EQ-5D-5L
Occurrence of Grade 3 or greater adverse event
All-cause mortality
Tecovirimat concentrations in blood in children less than 18 years of age

Full Information

First Posted
September 8, 2022
Last Updated
August 30, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
SIGA Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT05534984
Brief Title
Study of Tecovirimat for Human Monkeypox Virus
Acronym
STOMP
Official Title
A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

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

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
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease.
Detailed Description
Eligible and consented participants for the randomized arms (N=530) will be randomized 2:1 to receive either tecovirimat or placebo; participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants who are pregnant or breastfeeding will receive open-label tecovirimat after discussion of the potential risks and benefits. Participants less than 18 years of age will receive open-label tecovirimat. Participants receiving a potent inducing concomitant medication will receive open-label tecovirimat. Once enrolled, study drug administration will be for 14 days. Participants who progress to severe HMPXV disease will be seen in person for a confirmation of progression. If severe disease is confirmed, participants will stop blinded study treatment and start a 14-day course of open-label tecovirimat. Participants reporting severe pain 5 days after randomization will stop blinded study treatment and start a 14-day course of open-label tecovirimat. Participants will self-monitor skin and/or mucosal lesions daily through 29 days or resolution (whichever comes first), complete a daily diary of symptoms and complete a daily numerical rating scale for pain assessment. Participants will be seen weekly through day 29 for assessment of HMPXV disease, safety assessments, HMPXV sampling similar to that described for entry, and swabbing of new HMPXV lesions. Participants will be seen at day 57 to assess for possible recrudescence of infection (i.e., new lesions occurring after initial resolution of disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monkeypox, MPOX
Keywords
HMPXV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Title
Arm B
Arm Type
Placebo Comparator
Arm Title
Arm C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tecovirimat Oral Capsule
Intervention Description
Drug: Tecovirimat Oral capsules Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug: Placebo Oral capsules Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
Tecovirimat Oral Capsule (Open Label)
Intervention Description
Participants weighing 4 to <6kg and >7 days old - Tecovirimat 50mg every 12 hours for 14 days Participants weighing 2.5 to <4kg and >7 days to <4 weeks old - Tecovirimat 20 mg every 12 hours for 14 days Participants weighing 4 to <6kg and ≤7 days old - Tecovirimat 50mg every 24 hours for 14 days Participants weighing 2.5 to <4 kg and ≤7 days old - Tecovirimat 20mg every 24 hours for 14 days Participants weighing 6 kg to less than 13 kg - Tecovirimat 100 mg every 12 hours for 14 days Participants weighing 13 kg to less than 25 kg - Tecovirimat 200 mg every 12 hours for 14 days Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg (2 capsules) every 12 hours for 14 days Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
Primary Outcome Measure Information:
Title
Time to clinical resolution, defined as the first day on which all skin lesions are scabbed, desquamated or healed, and visible mucosal lesions are healed
Time Frame
Up to day 29
Secondary Outcome Measure Information:
Title
Pain assessed by 11-point numerical rating scale for pain
Time Frame
Through day 29
Title
Time to development of severe HMPXV in those without severe HMPXV at baseline
Time Frame
Through day 57
Title
Level of HMPXV in blood
Time Frame
Through day 57
Title
Level of HMPXV in skin lesions
Time Frame
Through day 57
Title
Level of HMPXV in oropharynx
Time Frame
Through day 57
Title
Level of HMPXV in rectum
Time Frame
Through day 57
Title
Level of HMPXV in genital secretions
Time Frame
Through day 57
Title
Time to complete lesion healing defined as all lesions being re-epithelialized
Time Frame
Up to day 29
Title
Participant-reported adherence
Time Frame
Through day 15
Title
Participant-reported quality-of-life as measured by EQ-5D-5L
Time Frame
Through day 29
Title
Occurrence of Grade 3 or greater adverse event
Time Frame
Through day 57
Title
All-cause mortality
Time Frame
Through day 57
Title
Tecovirimat concentrations in blood in children less than 18 years of age
Time Frame
Through day 15

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (All participants; Arms A, B, and C): Laboratory-confirmed or presumptive HMPXV infection. HMPXV illness of <14 days duration immediately prior to study entry. At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis with or without visible ulcers. Non-pregnant people of reproductive potential must agree to use at least one effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Additional Inclusion Criteria for Arms A and B: 1. Age ≥18 years at the time of study entry Additional Inclusion Criteria for Arm C; Participants who meet the above entry criteria who also meet any of the following criteria will be registered to Arm C: Participants age <18 years at the time of study entry Those with severe HMPXV disease Those with or without severe disease and with one or more of the following will also be enrolled into Arm C: Severe immunosuppression Skin conditions placing the person at higher risk for disseminated infection Exclusion Criteria (All participants; Arms A, B, and C): Prior or concomitant receipt of tecovirimat (e.g., under an alternative access mechanism. Planned initiation of intramuscular cabotegravir/rilpivirine during study drug administration or for two weeks following completion of study drug administration. Participants who are stable on long-acting intramuscular cabotegravir/rilpivirine may enroll. Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study. Participants who require intravenous dosing of tecovirimat.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ACTG Clinicaltrials.gov Coordinator
Phone
Please email at:
Email
ACTGCT.gov@fstrf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Wilkin, MD, MPH
Organizational Affiliation
Cornell
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Heath, IoR
Phone
205-996-2373
Email
slheath@uabmc.edu
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Towner, IoR
Email
william.j.towner@kp.org
Facility Name
Los Angeles LGBT Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Bolan, IoR
Phone
323-993-7577
Email
bbolan@lalgbtcenter.org
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhaela Cielo, IoR
Phone
323-865-1585
Email
mikhaela.cielo@usc.edu
Facility Name
UCLA CARE Center CRS
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 Landovitz, IoR
Phone
310-825-3782
Email
rlandovitz@mednet.ucla.edu
Facility Name
David Geffen School of Medicine at UCLA NICHD CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Deville, IoR
Phone
310-206-4173
Email
jdeville@mednet.ucla.edu
Facility Name
Easy Bay AIDS Center CRS City: Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Tang, IoR
Phone
510-869-8486
Email
michele.tang@sutterhealth.org
Facility Name
University of California, Davis CRS
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Cohen, IoR
Phone
916-734-3545
Email
stcohen@ucdavis.edu
Facility Name
UCSD Antiviral Research Center CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Little, IoR
Phone
619-543-8080
Email
Slittle@health.ucsd.edu
Facility Name
University of California, San Francisco HIV/AIDS CRS
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
Annie Luetkemeyer, IoR
Phone
415-476-4082
Ext
353
Email
annie.luetkemeyer@ucsf.edu
Facility Name
Harbor University of California Los Angeles Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Daar, IoR
Phone
424-201-3000
Email
edaar@lundquist.org
Facility Name
University of Colorado Denver NICHD 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
Betsy McFarland, IoR
Phone
720-777-1966
Email
Bety.McFarland@cuanschutz.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
Thomas Campbell, IoR
Phone
303-724-4929
Email
thomas.campbell@cuanschutz.edu
Facility Name
Denver Public Health CRS
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Gardner, IoR
Phone
303-602-8740
Email
edward.m.gardner@dhha.org
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Tuan, IoR
Phone
630-532-3325
Email
jessica.tuan@yale.edu
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Iovine, IoR
Email
Nicole.Iovine@medicine.ufl.edu
Facility Name
University of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mobeen Rathore, IoR
Phone
904-244-3539
Email
mobeen.rathore@jax.ufl.edu
Facility Name
University of Miami / Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Doblecki-Lewis, IoR
Phone
305-243-7652
Email
sdoblecki@med.miami.edu
Facility Name
University of Miami/Pediatric Perinatal HIV NICHD CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Mitchell, IoR
Phone
305-243-2755
Email
cmitchel@med.miami.edu
Facility Name
Univ. of South Florida (USF) College of Medicine A
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carina Rodriguez, IoR
Phone
813-259-8800
Email
crodrig1@usf.edu
Facility Name
The Ponce de Leon Center CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos del Rio, IoR
Phone
404-778-1405
Email
cdelrio@emory.edu
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Jao, IoR
Phone
312-227-4080
Email
jennifer.jao@northwestern.edu
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babafemi Taiwo, IoR
Phone
312-695-5085
Email
b-taiwo@northwestern.edu
Facility Name
Rush University Cook County Hospital Chicago NICHD CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Aziz, IoR
Phone
773-551-2040
Email
mariam_aziz@rush.edu
Facility Name
Rush University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shivanjali Shankaran, IoR
Phone
312-942-5865
Email
Shivanjali_Shankaran@rush.edu
Facility Name
Johns Hopkins University CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Hamill, IoR
Phone
410-550-9080
Email
mhamill6@jhu.edu
Facility Name
Massachusetts General Hospital CRS (MGH CRS)
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
Elizabeth Hohmann, IoR
Phone
617-724-7532
Email
EHOHMANN@mgh.harvard.edu
Facility Name
Brigham and Women's Hospital Therapeutics
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, IoR
Phone
617-726-0198
Email
JManne@BWH.Harvard.edu
Facility Name
Henry Ford Hospital CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indira Brar, IoR
Phone
313-673-9451
Email
ibrar1@hfhs.org
Facility Name
Washington University Therapeutics (WT) CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Racehl Presti, IoR
Phone
314-454-0058
Email
prestir@wustl.edu
Facility Name
University of Nebraska Medical Center (Specialty Care Center)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Bares, IoR
Phone
402-559-8218
Email
sara.bares@unmc.edu
Facility Name
New Jersey Medical School Clinical Research Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Chew, IoR
Phone
973-972-0320
Email
chewde@njms.rutgers.edu
Facility Name
Jacobi Medical Center Bronx NICHD CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Wiznia, IoR
Phone
718-918-4664
Email
andrew.wiznia@nychhc.org
Facility Name
Weill Cornell Chelsea CRS
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
Tim Wilkin, IoR
Phone
212-746-7202
Email
tiw2001@med.cornell.edu
Facility Name
Mount Sinai West Samuels CRS
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erna Kojic, IoR
Phone
646-957-5273
Email
Erna.Kojic@mountsinai.org
Facility Name
Harlem Prevention Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Mannheimer, IoR
Phone
212-939-2948
Email
sbm20@cumc.columbia.edu
Facility Name
Columbia Physicians & Surgeons (P&S) CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Zucker, IoR
Phone
212-305-5265
Email
jz2700@cumc.columbia.edu
Facility Name
Weill Cornell Uptown CRS
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Wilkin, IoR
Phone
212-746-7202
Email
tiw2001@med.cornell.edu
Facility Name
Bronx-Lebanon Hospital Center NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murli Purswani, IoR
Phone
917-754-0701
Email
mpurswan@bronxcare.org
Facility Name
Infectious Disease Clinical and Translational Research
City
New York
State/Province
New York
ZIP/Postal Code
11029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Aberg, IoR
Phone
212-241-6741
Email
judith.aberg@mssm.edu
Facility Name
University of Rochester Adult HIV Therapeutic
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
Sonal Munsiff, IoR
Phone
585-276-7199
Email
Sonal_Munsiff@URMC.Rochester.edu
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Nachman, IoR
Phone
631-444-7692
Email
sharon.nachman@stonybrookmedicine.edu
Facility Name
Duke University Medical Center CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Completed
Facility Name
Wake Forest Baptist Medical Center CRS
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Wilkin, IoR
Phone
336-716-8978
Email
awilkin@wakehealth.edu
Facility Name
Cincinnati CRS
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Fichtenbaum, IoR
Phone
513-584-6361
Email
FICHTECJ@UCMAIL.UC.EDU
Facility Name
Case Western Reserve University CTU
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, IoR
Phone
216-844-2342
Email
jxj573@case.edu
Facility Name
Ohio State University CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Bazan, IoR
Phone
614-293-5666
Email
Jose.Bazan@osumc.edu
Facility Name
Penn Therapeutics CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Short, IoR
Phone
215-662-8693
Email
william.short@pennmedicine.upenn.edu
Facility Name
University of Pittsburgh CRS
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Ho, IoR
Phone
412-383-7178
Email
hok2@upmc.edu
Facility Name
St. Jude Children's Research Hospital ATN CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Knapp, IoR
Phone
901-595-4645
Email
katherine.knapp@stjude.org
Facility Name
Vanderbilt Therapeutics CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Haas, IoR
Phone
615-260-3364
Email
david.haas@vumc.org
Facility Name
Trinity Health and Wellness Center CRS
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Bedimo, IoR
Email
Roger.Bedimo@va.gov
Facility Name
North Texas Infectious Disease Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uriel Sandkovsky, IoR
Phone
214-823-2533
Email
uriel.sandkovsky@ntidc.org
Facility Name
UT Southwestern Infectious Disease Research Unit
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Kitchell, IoR
Phone
214-648-9914
Email
Ellen.Kitchell@UTSouthwestern.edu
Facility Name
Baylor College of Medicine / Texas Children's Hospital NICHD CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Paul, IoR
Phone
832-822-1038
Email
mpaul@bcm.edu
Facility Name
Houston AIDS Research Team (HART) CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Vigil, IoR
Phone
713-500-6703
Email
Karen.J.Vigil@uth.tmc.edu
Facility Name
University of Texas, San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Patterson, IoR
Phone
210-567-4823
Email
PATTERSON@uthscsa.edu
Facility Name
Virginia Commonwealth University Division of Infectious Diseases
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Shishido, IoR
Phone
631-655-1984
Email
Akira.Shishido@vcuhealth.org
Facility Name
University of Washington Positive Research
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Bender-Ignacio, IoR
Phone
206-744-4876
Email
rbi13@uw.edu
Facility Name
Fundacion Huesped CRS
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Ines Figueroa, IoR
Email
maria.figueroa@huesped.org.ar
Facility Name
Hospital Nossa Senhora da Conceicao CRS
City
Porto Alegre
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Breno Santos, IoR
Email
breno@ghc.com.br
Facility Name
Centro de Pesquisas Clínicas IC-HCFMUSP CRS
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Ghilardi, IoR
Email
fabio.ghilardi81@gmail.com
Facility Name
Centro de Referencia e Treinamento DST/AIDS CRS
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Valdez Madruga, IoR
Email
valdezmr@uol.com.br
Facility Name
University of Sao Paolo
City
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo De Carvalho Santana, IoR
Facility Name
National Center for Global Health and Medicine
City
Tokyo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norio Ohmagari, IoR
Email
nohmagari@hosp.ncgm.go.jp
Facility Name
Nutricion Mexico CRS
City
Mexico City
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Sierra Madero, IoR
Email
jsmadero@yahoo.com
Facility Name
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) CRS
City
Callao
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Jose Montenegro, IoR
Facility Name
Barranco CRS
City
Lima
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mey Leon, IoR
Email
mleon@impactaperu.org
Facility Name
San Miguel CRS
City
Lima
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Antonio Narrea Cango, IoR
Email
jnarrea@impactaperu.org
Facility Name
Socios En Salud Sucursal Peru
City
Lima
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Augusto Magno Tarazona Fernandez, IoR
Email
atarazona_ses@pih.org
Facility Name
Via Libre CRS
City
Lima
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Alfredo Hidalgo Vidal, IoR
Email
pepinhidalgo@yahoo.com
Facility Name
IMPAACT/ Gamma Project/ UPR Pediatric HIV/AIDS Research CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irma Febo-Rodriguez, IoR
Phone
787-759-9595
Email
irma.febo2@upr.edu
Facility Name
Puerto Rico AIDS Clinical Trials Unit CRS
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Santana, IoR
Email
jorge.santana3@upr.edu
Facility Name
Soweto CRS
City
Johannesburg
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lerato Mohapi
Email
mohapil@phru.co.za
Facility Name
University of the Witwatersrand Helen Joseph (WITS HJH)
City
Johannesburg
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharlaa Badal-Faesen, IoR
Email
sfaesen@witshealth.co.za
Facility Name
Thai Red Cross AIDS Research Centre
City
Bangkok
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anchalee Avihingsanon, IoR
Email
anchaleea2009@gmail.com

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

Study of Tecovirimat for Human Monkeypox Virus

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