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A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

Primary Purpose

HIV Infection

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DOR/ISL
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

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

Inclusion Criteria: Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]). Exclusion Criteria: Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033. Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL. Is a HTE participant receiving treatment in MK-8591A-019 or -033.

Sites / Locations

  • University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)Recruiting
  • Pueblo Family Physicians ( Site 3102)
  • Pacific Oaks Medical Group ( Site 3123)
  • Kaiser Permanente ( Site 3124)Recruiting
  • Ruane Clinical Research Group, Inc ( Site 3126)Recruiting
  • Mills Clinical Research ( Site 3114)Recruiting
  • University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)Recruiting
  • Georgetown University Medical Center ( Site 3130)Recruiting
  • Therafirst Medical Center ( Site 3110)Recruiting
  • Midway Immunology and Research Center ( Site 3117)Recruiting
  • Floridian Clinical Research, LLC ( Site 3133)Recruiting
  • AHF The Kinder Medical Group ( Site 3108)Recruiting
  • Orlando Immunology Center ( Site 3106)Recruiting
  • Bliss Healthcare Services ( Site 3115)Recruiting
  • CAN Community Health - Sarasota ( Site 3118)Recruiting
  • Triple O Research Institute, P.A ( Site 3116)Recruiting
  • Augusta University-Infectious Diseases ( Site 3135)Recruiting
  • Infectious Disease Specialists of Atlanta ( Site 3128)Recruiting
  • Mercer university, Department of internal medicine-Clinical Research ( Site 3129)Recruiting
  • Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)Recruiting
  • KC CARE Health Center ( Site 3103)Recruiting
  • ID Care ( Site 3131)
  • Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)Recruiting
  • Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
  • St Hope Foundation ( Site 3121)Recruiting
  • North Texas Infectious Diseases Consultants, P.A ( Site 3100)Recruiting
  • Texas Centers for Infectious Disease Associates ( Site 3111)Recruiting
  • The Crofoot Research Center ( Site 3101)Recruiting
  • DCOL Center for Clinical Research ( Site 3119)Recruiting
  • Private Practice - Dr. Peter Shalit ( Site 3120)
  • Multicare Institute for Research and Innovation ( Site 3127)Recruiting
  • Instituto Oulton ( Site 1004)Recruiting
  • Instituto CAICI SRL ( Site 1003)Recruiting
  • Helios Salud ( Site 1002)Recruiting
  • Fundación Huésped ( Site 1001)Recruiting
  • Fundación IDEAA ( Site 1005)Recruiting
  • Holdsworth House Medical Practice ( Site 1100)Recruiting
  • St Vincent's Hospital-IBAC ( Site 1103)Recruiting
  • Holdsworth House Medical Practice - Brisbane ( Site 1101)Recruiting
  • Prahran Market Clinic ( Site 1102)Recruiting
  • Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
  • Maple Leaf Research ( Site 1301)Recruiting
  • Toronto General Hospital ( Site 1300)
  • Clinique de médecine Urbaine du Quartier Latin ( Site 1305)Recruiting
  • Clinique Medicale lActuel ( Site 1303)
  • McGill University Health Centre ( Site 1306)Recruiting
  • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)Recruiting
  • Clinica Universidad Catolica del Maule ( Site 1405)Recruiting
  • Biomedica Research Group-Infectology ( Site 1401)Recruiting
  • Pontificia Universidad Catolica de Chile ( Site 1407)Recruiting
  • Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400)Recruiting
  • Cardio Sur ( Site 1409)Recruiting
  • Fundacion Valle del Lili- CIC ( Site 1500)Recruiting
  • Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)Recruiting
  • Hadassah Medical Center-Infecious Disease ( Site 1902)Recruiting
  • Sheba Medical Center-HIV unit ( Site 1903)Recruiting
  • Sourasky Medical Center ( Site 1904)
  • National Hospital Organization Nagoya Medical Center ( Site 2103)
  • Tokyo Metropolitan Komagome Hospital ( Site 2105)
  • Tokyo Medical University Hospital ( Site 2104)
  • Center Hospital of the National Center for Global Health and Medicine ( Site 2101)
  • National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21
  • Christchurch Hospital-Infectious Diseases ( Site 2200)
  • Clinical Research Puerto Rico ( Site 2400)Recruiting
  • HOPE Clinical Research ( Site 2401)Recruiting
  • Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)Recruiting
  • Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504)Recruiting
  • Republican Clinical Infectious Hospital ( Site 2500)Recruiting
  • Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506)
  • Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502)Recruiting
  • Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for ProphylactRecruiting
  • Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)Recruiting
  • Josha Research ( Site 2603)Recruiting
  • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605)Recruiting
  • Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609)Recruiting
  • Ezintsha-Clinical Research Site ( Site 2607)Recruiting
  • Private Practice Dr. Marleen de Jager ( Site 2600)Recruiting
  • Wentworth Hospital ( Site 2604)Recruiting
  • Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)Recruiting
  • Desmond Tutu Health Foundation ( Site 2602)Recruiting
  • Be Part Yoluntu Centre ( Site 2601)Recruiting
  • University Hospital Basel-Infectiology ( Site 2802)
  • Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804)
  • Cantonal Hospital St.Gallen ( Site 2801)
  • Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805)
  • UniversitätsSpital Zürich ( Site 2800)
  • Inselspital Bern-Inselspital Infektiologie ( Site 2803)
  • Kaohsiung Veterans General Hospital ( Site 2901)
  • University Hospitals Sussex NHS Foundation Trust ( Site 3004)Recruiting
  • Southmead Hospital ( Site 3003)Recruiting
  • Royal Free Hospital ( Site 3002)Recruiting
  • King's College Hospital ( Site 3001)Recruiting
  • North Manchester General Hospital ( Site 3005)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DOR/ISL

Arm Description

Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96.

Outcomes

Primary Outcome Measures

Percentage of Participants with One or More Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 102 will be presented.
Percentage of participants who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.

Secondary Outcome Measures

Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96
The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.
Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96
The percentage of participants with HIV-1 RNA ≥200 copies/mL at Week 96 will be reported
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
Viral drug resistance is defined as participants with HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented.

Full Information

First Posted
March 1, 2023
Last Updated
October 5, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05766501
Brief Title
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
Official Title
A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
January 14, 2026 (Anticipated)
Study Completion Date
January 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
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
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DOR/ISL
Arm Type
Experimental
Arm Description
Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96.
Intervention Type
Drug
Intervention Name(s)
DOR/ISL
Other Intervention Name(s)
MK-8591A, Doravirine/islatravir
Intervention Description
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Primary Outcome Measure Information:
Title
Percentage of Participants with One or More Adverse Event (AE)
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience an AE through Week 102 will be presented.
Time Frame
Up to 102 Weeks
Title
Percentage of participants who Discontinue Study Intervention Due to an AE
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study intervention due to an AE through Week 96 will be presented.
Time Frame
Up to 96 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) ≥50 copies/mL at Week 96
Description
The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 will be reported.
Time Frame
Week 96
Title
Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
Description
The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 will be reported.
Time Frame
Week 96
Title
Percentage of Participants with HIV-1 RNA ≥200 copies/mL at Week 96
Description
The percentage of participants with HIV-1 RNA ≥200 copies/mL at Week 96 will be reported
Time Frame
Week 96
Title
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
Description
Viral drug resistance is defined as participants with HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic data showing evidence of resistance to the study intervention. The percentage of participants who demonstrate drug resistance through Week 96 will be presented.
Time Frame
Up to Week 96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]). Exclusion Criteria: Has confirmed HIV-1 RNA ≥200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033. Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL. Is a HTE participant receiving treatment in MK-8591A-019 or -033.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham-UAB 1917 Research Clinic ( Site 3104)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
205-532-3529
Facility Name
Pueblo Family Physicians ( Site 3102)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Pacific Oaks Medical Group ( Site 3123)
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kaiser Permanente ( Site 3124)
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
Study Coordinator
Phone
323-783-7404
Facility Name
Ruane Clinical Research Group, Inc ( Site 3126)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-740-6944
Facility Name
Mills Clinical Research ( Site 3114)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-729-9265
Facility Name
University of California Davis Health-Internal Medicine: Infectious Diseases ( Site 3137)
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
Study Coordinator
Phone
916-734-8431
Facility Name
Georgetown University Medical Center ( Site 3130)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
202-444-0152
Facility Name
Therafirst Medical Center ( Site 3110)
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-564-4222
Facility Name
Midway Immunology and Research Center ( Site 3117)
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
772-464-9746
Facility Name
Floridian Clinical Research, LLC ( Site 3133)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
954-439-0531
Facility Name
AHF The Kinder Medical Group ( Site 3108)
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
786-497-4000
Facility Name
Orlando Immunology Center ( Site 3106)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-647-3960
Facility Name
Bliss Healthcare Services ( Site 3115)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
407-761-4579
Facility Name
CAN Community Health - Sarasota ( Site 3118)
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
941-366-0234
Facility Name
Triple O Research Institute, P.A ( Site 3116)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
561-855-7871
Facility Name
Augusta University-Infectious Diseases ( Site 3135)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
706-721-6688
Facility Name
Infectious Disease Specialists of Atlanta ( Site 3128)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-297-9755
Facility Name
Mercer university, Department of internal medicine-Clinical Research ( Site 3129)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
478-301-5851
Facility Name
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 3105)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
912-441-7728
Facility Name
KC CARE Health Center ( Site 3103)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
816-777-2759
Facility Name
ID Care ( Site 3131)
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 3134)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
212-824-7821
Facility Name
Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St Hope Foundation ( Site 3121)
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-839-7111
Facility Name
North Texas Infectious Diseases Consultants, P.A ( Site 3100)
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
Study Coordinator
Phone
214-823-2533
Facility Name
Texas Centers for Infectious Disease Associates ( Site 3111)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
817-348-0042
Facility Name
The Crofoot Research Center ( Site 3101)
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
713-526-0005
Facility Name
DCOL Center for Clinical Research ( Site 3119)
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
903-238-8854
Facility Name
Private Practice - Dr. Peter Shalit ( Site 3120)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Multicare Institute for Research and Innovation ( Site 3127)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
801-859-9934
Facility Name
Instituto Oulton ( Site 1004)
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5000JJS
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
54 3515487840
Facility Name
Instituto CAICI SRL ( Site 1003)
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
543414248045
Facility Name
Helios Salud ( Site 1002)
City
Buenos Aires
ZIP/Postal Code
C1141ACG
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
541143637462
Facility Name
Fundación Huésped ( Site 1001)
City
Buenos Aires
ZIP/Postal Code
C1202ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5491144240726
Facility Name
Fundación IDEAA ( Site 1005)
City
Buenos Aires
ZIP/Postal Code
C1405CKC
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5491161835390
Facility Name
Holdsworth House Medical Practice ( Site 1100)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61280381044
Facility Name
St Vincent's Hospital-IBAC ( Site 1103)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61283821111
Facility Name
Holdsworth House Medical Practice - Brisbane ( Site 1101)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0417078066
Facility Name
Prahran Market Clinic ( Site 1102)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61395140888
Facility Name
Hamilton Health Sciences- Urgent Care Centre ( Site 1304)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1A4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Maple Leaf Research ( Site 1301)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4164657936
Facility Name
Toronto General Hospital ( Site 1300)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Clinique de médecine Urbaine du Quartier Latin ( Site 1305)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
514-285-5500
Facility Name
Clinique Medicale lActuel ( Site 1303)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
McGill University Health Centre ( Site 1306)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5148432090
Facility Name
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 1403)
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4781151
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56996420376
Facility Name
Clinica Universidad Catolica del Maule ( Site 1405)
City
Talca
State/Province
Maule
ZIP/Postal Code
3465584
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56965875525
Facility Name
Biomedica Research Group-Infectology ( Site 1401)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56993332624
Facility Name
Pontificia Universidad Catolica de Chile ( Site 1407)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8330034
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56223543165
Facility Name
Universidad de Chile - Hospital Clínico Universidad de Chile-Inmunologia Alergia y VIH ( Site 1400)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380420
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
56992280653
Facility Name
Cardio Sur ( Site 1409)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8910259
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+56963108092
Facility Name
Fundacion Valle del Lili- CIC ( Site 1500)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5723319090ext7421
Facility Name
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 1901)
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972502061699
Facility Name
Hadassah Medical Center-Infecious Disease ( Site 1902)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972507874340
Facility Name
Sheba Medical Center-HIV unit ( Site 1903)
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
972526667525
Facility Name
Sourasky Medical Center ( Site 1904)
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 2103)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 2105)
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Medical University Hospital ( Site 2104)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Center Hospital of the National Center for Global Health and Medicine ( Site 2101)
City
Shinjyuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 21
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Christchurch Hospital-Infectious Diseases ( Site 2200)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research Puerto Rico ( Site 2400)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7877235945
Facility Name
HOPE Clinical Research ( Site 2401)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
7876402214
Facility Name
Kemerovo Regional Center for the Prevention and Control of AIDS and Infectious Diseases ( Site 2505)
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650056
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+79069261368
Facility Name
Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2504)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660049
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+79029431209
Facility Name
Republican Clinical Infectious Hospital ( Site 2500)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
196645
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
78124649329
Facility Name
Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2506)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105275
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2502)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
115035
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+74953653009
Facility Name
Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
190020
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
79219344711
Facility Name
Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2503)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420140
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+78432678095
Facility Name
Josha Research ( Site 2603)
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27(0)825724467
Facility Name
Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 2605)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27119899835
Facility Name
Helen Joseph Hospital-Clinical HIV Research Unit ( Site 2609)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2092
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27112768800
Facility Name
Ezintsha-Clinical Research Site ( Site 2607)
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
011-0844933
Facility Name
Private Practice Dr. Marleen de Jager ( Site 2600)
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27123412510
Facility Name
Wentworth Hospital ( Site 2604)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4052
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27837471149 27312611093
Facility Name
Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 2608)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0796724398
Facility Name
Desmond Tutu Health Foundation ( Site 2602)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27213860053
Facility Name
Be Part Yoluntu Centre ( Site 2601)
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7646
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+27836041100
Facility Name
University Hospital Basel-Infectiology ( Site 2802)
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2804)
City
Genève
State/Province
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Cantonal Hospital St.Gallen ( Site 2801)
City
st.Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2805)
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6903
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
UniversitätsSpital Zürich ( Site 2800)
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Inselspital Bern-Inselspital Infektiologie ( Site 2803)
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Kaohsiung Veterans General Hospital ( Site 2901)
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
University Hospitals Sussex NHS Foundation Trust ( Site 3004)
City
East Sussex
State/Province
Brighton And Hove
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
441273523079
Facility Name
Southmead Hospital ( Site 3003)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4401174148130
Facility Name
Royal Free Hospital ( Site 3002)
City
London
State/Province
England
ZIP/Postal Code
NW32QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
442074726232
Facility Name
King's College Hospital ( Site 3001)
City
London
State/Province
London, City Of
ZIP/Postal Code
SE5 9RL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
442078485779
Facility Name
North Manchester General Hospital ( Site 3005)
City
Crumpsall
State/Province
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
07859222599

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=8591A-054&&kw=8591A-054
Description
Plain Language Summary

Learn more about this trial

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

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