Back to resultsOpen-label, Follow-up of Doravirine/Islatravir for Participants With Human Immunodeficiency Virus -1 (HIV-1) Infection (MK-8591A-033)
Primary Purpose
HIV-1 Infection
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MK-8591A
Sponsored by
About this trial
This is an interventional treatment trial for HIV-1 Infection
Eligibility Criteria
Inclusion Criteria:
- Is currently receiving DOR/ISL adult FDC tablet in a MSD-sponsored clinical study and has completed the last treatment visit.
- Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
- Is male or female and ≥35 kg at the time of signing the informed consent/assent.
- Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)
Exclusion Criteria:
- Is taking or is anticipated to require any prohibited therapies.
Sites / Locations
- Pueblo Family Physicians ( Site 0010)
- One Community Health ( Site 0045)
- Whitman-Walker Institute ( Site 0039)
- Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
- Midway Immunology and Research Center ( Site 0033)
- Orlando Immunology Center ( Site 0017)
- Bliss Healthcare Services-Research ( Site 0030)
- Triple O Research Institute, P.A ( Site 0031)
- Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)
- Northstar Healthcare ( Site 0003)
- KC CARE Health Center-Clinical Trials ( Site 0012)
- ID Care ( Site 0028)
- Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)Recruiting
- Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site
- St Hope Foundation ( Site 0041)
- North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)
- Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)
- The Crofoot Research Center ( Site 0008)
- Holdsworth House Medical Practice ( Site 0700)
- St Vincent's Hospital-IBAC ( Site 0702)
- Fiona Stanley Hospital ( Site 0706)
- Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)
- Vancouver Infectious Diseases Centre ( Site 0100)
- Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)
- Maple Leaf Research ( Site 0105)
- Toronto General Hospital ( Site 0104)
- Clinique de médecine Urbaine du Quartier Latin ( Site 0110)
- Clinique Medicale lActuel ( Site 0108)
- Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)Recruiting
- Biomedica Research Group-Infectology ( Site 0201)
- Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204)Recruiting
- Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200)
- Fundacion Valle del Lili- CIC ( Site 0300)
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)
- Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)
- CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)
- CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)
- CHU Charles Nicolle-Inefectious disease ( Site 1506)
- Hospital La Colombière ( Site 1518)Recruiting
- Hôpital Avicenne ( Site 1502)
- Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)
- Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)
- Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)
- Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)
- Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)Recruiting
- Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)
- Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)
- Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)
- Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (
- Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)
- National Hospital Organization Nagoya Medical Center ( Site 0903)
- Tokyo Medical University Hospital ( Site 0904)
- Center Hospital of the National Center for Global Health and Medicine ( Site 0901)
- National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09
- Tokyo Metropolitan Komagome Hospital ( Site 0906)
- Christchurch Hospital-Infectious Diseases ( Site 0800)
- Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)
- EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)
- WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)
- Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)
- Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)
- Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)
- Republican Clinical Infectious Hospital ( Site 2300)
- Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)
- Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)
- Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact
- Smolensk Center for prevention and control of AIDS ( Site 2308)Recruiting
- Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)
- Josha Research ( Site 2403)Recruiting
- Ezintsha ( Site 2404)Recruiting
- Mediclinc Muelmed ( Site 2401)Recruiting
- King Edward VIII Hospital ( Site 2410)Recruiting
- Wentworth Hospital ( Site 2400)Recruiting
- Desmond Tutu Health Foundation ( Site 2402)
- Hospital General Universitario de Elche-Infectius Disease ( Site 1908)
- Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)
- HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)
- Hospital Universitario Infanta Leonor ( Site 1906)
- Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)
- Hospital Universitario La Paz-Internal Medicine ( Site 1904)
- University Hospital Basel-Infectiology ( Site 2002)
- Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)
- Cantonal Hospital St.Gallen ( Site 2001)
- Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005)
- UniversitätsSpital Zürich ( Site 2000)
- Inselspital Bern-Inselspital Infektiologie ( Site 2003)
- Brighton and Sussex University Hospitals NHS Trust ( Site 2104)Recruiting
- Southmead Hospital ( Site 2103)
- Royal Free Hospital ( Site 2102)Recruiting
- King's College Hospital ( Site 2101)Recruiting
- North Manchester General Hospital ( Site 2105)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MK-8591A
Arm Description
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 96 weeks.
Outcomes
Primary Outcome Measures
Participants with serious adverse events (SAEs)
Percentage of participants with serious adverse events (SAEs)
Participants who discontinued due to an adverse event (AE)
Percentage of participants who discontinued study treatment due to an AE.
Secondary Outcome Measures
Full Information
NCT ID
NCT04776252
First Posted
February 26, 2021
Last Updated
October 19, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04776252
Brief Title
Open-label, Follow-up of Doravirine/Islatravir for Participants With Human Immunodeficiency Virus -1 (HIV-1) Infection (MK-8591A-033)
Official Title
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
October 7, 2025 (Anticipated)
Study Completion Date
October 7, 2025 (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 safety and tolerability of MK-8591A, a novel 2-drug fixed dose combination (FDC) of doravirine (DOR) and islatravir (ISL) will be evaluated in adult and pediatric participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1 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
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MK-8591A
Arm Type
Experimental
Arm Description
Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 96 weeks.
Intervention Type
Drug
Intervention Name(s)
MK-8591A
Intervention Description
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for 96 weeks
Primary Outcome Measure Information:
Title
Participants with serious adverse events (SAEs)
Description
Percentage of participants with serious adverse events (SAEs)
Time Frame
Up to Week 102
Title
Participants who discontinued due to an adverse event (AE)
Description
Percentage of participants who discontinued study treatment due to an AE.
Time Frame
Up to Week 96
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is currently receiving DOR/ISL adult FDC tablet in a MSD-sponsored clinical study and has completed the last treatment visit.
Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
Is male or female and ≥35 kg at the time of signing the informed consent/assent.
Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines)
Exclusion Criteria:
Is taking or is anticipated to require any prohibited therapies.
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
Pueblo Family Physicians ( Site 0010)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Individual Site Status
Completed
Facility Name
One Community Health ( Site 0045)
City
Sacramento
State/Province
California
ZIP/Postal Code
95811
Country
United States
Individual Site Status
Completed
Facility Name
Whitman-Walker Institute ( Site 0039)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Individual Site Status
Completed
Facility Name
Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Midway Immunology and Research Center ( Site 0033)
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Individual Site Status
Completed
Facility Name
Orlando Immunology Center ( Site 0017)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Completed
Facility Name
Bliss Healthcare Services-Research ( Site 0030)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Completed
Facility Name
Triple O Research Institute, P.A ( Site 0031)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Northstar Healthcare ( Site 0003)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
KC CARE Health Center-Clinical Trials ( Site 0012)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Completed
Facility Name
ID Care ( Site 0028)
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Individual Site Status
Completed
Facility Name
Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)
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
Completed
Facility Name
St Hope Foundation ( Site 0041)
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Completed
Facility Name
North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Completed
Facility Name
The Crofoot Research Center ( Site 0008)
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Individual Site Status
Completed
Facility Name
Holdsworth House Medical Practice ( Site 0700)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Completed
Facility Name
St Vincent's Hospital-IBAC ( Site 0702)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Fiona Stanley Hospital ( Site 0706)
City
Murdock
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Completed
Facility Name
Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R 0X7
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Vancouver Infectious Diseases Centre ( Site 0100)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1A4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Maple Leaf Research ( Site 0105)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1K2
Country
Canada
Individual Site Status
Completed
Facility Name
Toronto General Hospital ( Site 0104)
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 0110)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Individual Site Status
Completed
Facility Name
Clinique Medicale lActuel ( Site 0108)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Individual Site Status
Completed
Facility Name
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)
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
56452556805
Facility Name
Biomedica Research Group-Infectology ( Site 0201)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
7500710
Country
Chile
Individual Site Status
Completed
Facility Name
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204)
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 ( Site 0200)
City
Santiago
State/Province
Region M. De Santiago
ZIP/Postal Code
8380420
Country
Chile
Individual Site Status
Active, not recruiting
Facility Name
Fundacion Valle del Lili- CIC ( Site 0300)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760032
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06202
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33075
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)
City
Toulouse
State/Province
Haute-Garonne
ZIP/Postal Code
31400
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Charles Nicolle-Inefectious disease ( Site 1506)
City
Rouen
State/Province
Haute-Normandie
ZIP/Postal Code
76031
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hospital La Colombière ( Site 1518)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34090
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33467337220
Facility Name
Hôpital Avicenne ( Site 1502)
City
Bobigny
State/Province
Ile-de-France
ZIP/Postal Code
93000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75013
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093 Cedex 1
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)
City
Tourcoing
State/Province
Nord
ZIP/Postal Code
59200
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)
City
Lyon
State/Province
Rhone
ZIP/Postal Code
69004
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33140257594
Facility Name
Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Completed
Facility Name
Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)
City
Milan
State/Province
Milano
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 0903)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Completed
Facility Name
Tokyo Medical University Hospital ( Site 0904)
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Completed
Facility Name
Center Hospital of the National Center for Global Health and Medicine ( Site 0901)
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 09
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Individual Site Status
Completed
Facility Name
Tokyo Metropolitan Komagome Hospital ( Site 0906)
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Christchurch Hospital-Infectious Diseases ( Site 0800)
City
Christchurch
State/Province
Canterbury
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Completed
Facility Name
Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-136
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-220
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)
City
Ód
State/Province
Lodzkie
ZIP/Postal Code
90-001
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
01-201
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)
City
Kemerovo
State/Province
Kemerovskaya Oblast
ZIP/Postal Code
650056
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)
City
Krasnoyarsk
State/Province
Krasnoyarskiy Kray
ZIP/Postal Code
660049
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Republican Clinical Infectious Hospital ( Site 2300)
City
Saint Petersburg
State/Province
Leningradskaya Oblast
ZIP/Postal Code
196645
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105275
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)
City
Moscow
State/Province
Moskva
ZIP/Postal Code
105275
Country
Russian Federation
Individual Site Status
Completed
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
Active, not recruiting
Facility Name
Smolensk Center for prevention and control of AIDS ( Site 2308)
City
Smolensk
State/Province
Smolenskaya Oblast
ZIP/Postal Code
214006
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+79107152097
Facility Name
Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420140
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Josha Research ( Site 2403)
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
+27514128160
Facility Name
Ezintsha ( Site 2404)
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
+27110844997
Facility Name
Mediclinc Muelmed ( Site 2401)
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
King Edward VIII Hospital ( Site 2410)
City
Durban
State/Province
Kwazulu-Natal
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
27312611093
Facility Name
Wentworth Hospital ( Site 2400)
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
27312611093
Facility Name
Desmond Tutu Health Foundation ( Site 2402)
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario de Elche-Infectius Disease ( Site 1908)
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Infanta Leonor ( Site 1906)
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario La Paz-Internal Medicine ( Site 1904)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Basel-Infectiology ( Site 2002)
City
Basel
State/Province
Aargau
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)
City
Geneva
State/Province
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Cantonal Hospital St.Gallen ( Site 2001)
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 2005)
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6903
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
UniversitätsSpital Zürich ( Site 2000)
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Inselspital Bern-Inselspital Infektiologie ( Site 2003)
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Active, not recruiting
Facility Name
Brighton and Sussex University Hospitals NHS Trust ( Site 2104)
City
East Sussex
State/Province
Brighton And Hove
ZIP/Postal Code
BN2 5BE
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 2103)
City
Bristol
State/Province
Bristol, City Of
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Royal Free Hospital ( Site 2102)
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 2101)
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
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 2105)
City
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
+44 (0)161 922 3097
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
Learn more about this trial
Open-label, Follow-up of Doravirine/Islatravir for Participants With Human Immunodeficiency Virus -1 (HIV-1) Infection (MK-8591A-033)
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