Clinical trial NCT04233216: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
Official title: A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1 Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

Detailed description: Part 1 of this study (Day 1 to Day 7) is the double-blind period in which participants receive either ISL, DOR, DOR/ISL, or placebo. Part 2 of this study (Day 8 to Week 97) is the open-label period in which all participants receive DOR/ISL + optimized background therapy (OBT).

Eligibility criteria: Inclusion Criteria:

* Is HIV-1 positive.
* Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form.
* Weighs ≥35 kg.
* Has at least triple-class resistance (must include nucleoside reverse transcriptase inhibitor \[NRTI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and resistance to either protease inhibitor (PI) or integrase strand transfer inhibitor (InSTI), based on central laboratory-based resistance or proviral DNA resistance testing at the Screening Visit, or historical resistance testing within 12 months of screening.
* Has ≤2 fully active antiretroviral drugs remaining among all antiretroviral classes that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or acceptability to participant.
* If female, is not pregnant or breastfeeding, and is: 1) not a woman of childbearing potential (WOCBP); 2) a WOCBP and uses an acceptable method of contraception/is abstinent; or 3) a WOCBP and has a negative pregnancy test within 24 hours of the first dose of study medication.

Exclusion Criteria:

* Has HIV type 2 (HIV-2) infection.
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
* Has hepatitis B virus (HBV) co-infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive) and is not currently being treated for HBV.
* Has a history or current evidence of any condition, therapy (including active TB co-infection), laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with study participation for the full study duration.
* Is taking or is anticipated to require any of the prohibited therapies from the Screening Visit and throughout the study treatment period.
* Is taking DOR as part of his/her current failing antiretroviral regimen.
* Is taking efavirenz (EFV), etravirine, or nevirapine.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period.
* Is female and is expecting to conceive or donate eggs at any time during the study.

Primary outcomes:
measure: Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants With ≥1 AEs Through Week 49
timeFrame: Up to 49 weeks
measure: Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25
timeFrame: Up to 25 weeks
measure: Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25
timeFrame: Up to 25 weeks
measure: Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49
timeFrame: Up to 49 weeks
Secondary outcomes:
measure: Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97
timeFrame: Up to 97 weeks
measure: Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97
timeFrame: Up to 97 weeks
measure: Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
timeFrame: Day 1 (baseline) and Day 8
measure: Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
timeFrame: Day 1 (baseline) and Day 8
measure: Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
timeFrame: Day 1 (baseline) and Week 25
measure: Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
timeFrame: Day 1 (baseline) and Week 49
measure: Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
timeFrame: Day 1 (baseline) and Week 97
measure: Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
timeFrame: Day 8 (baseline) and Week 25
measure: Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
timeFrame: Day 8 (baseline) and Week 49
measure: Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
timeFrame: Day 8 (baseline) and Week 97
measure: Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
timeFrame: Day 1 (baseline) and Week 25
measure: Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
timeFrame: Day 1 (baseline) and Week 49
measure: Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
timeFrame: Day 1 (baseline) and Week 97
measure: Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
timeFrame: Day 8 (baseline) and Week 25
measure: Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
timeFrame: Day 8 (baseline) and Week 49
measure: Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
timeFrame: Day 8 (baseline) and Week 97
measure: Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
timeFrame: Day 1 (baseline) and Week 25
measure: Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
timeFrame: Day 1 (baseline) and Week 49
measure: Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
timeFrame: Day 1 (baseline) and Week 97
measure: Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
timeFrame: Day 8 (baseline) and Week 25
measure: Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
timeFrame: Day 8 (baseline) and Week 49
measure: Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
timeFrame: Day 8 (baseline) and Week 97
measure: Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL
timeFrame: Day 1 (baseline) and Day 8
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25
timeFrame: Week 25
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49
timeFrame: Week 49
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97
timeFrame: Week 97
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25
timeFrame: Week 25
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49
timeFrame: Week 49
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97
timeFrame: Week 97
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25
timeFrame: Week 25
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49
timeFrame: Week 49
measure: Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97
timeFrame: Week 97
measure: Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25
timeFrame: Week 25
measure: Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49
timeFrame: Week 49
measure: Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25
timeFrame: Week 25
measure: Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49
timeFrame: Week 49
measure: Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25
timeFrame: Week 25
measure: Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49
timeFrame: Week 49
measure: Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25
timeFrame: Week 25
measure: Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49
timeFrame: Week 49
measure: Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97
timeFrame: Week 97
measure: Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25
timeFrame: Week 25
measure: Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49
timeFrame: Week 49
measure: Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97
timeFrame: Week 97
measure: Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group
timeFrame: Day 1 (baseline) and Week 25
measure: Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
timeFrame: Day 1 (baseline) and Week 49
measure: Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
timeFrame: Day 1 (baseline) and Week 97
measure: Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group
timeFrame: Day 8 (baseline) and Week 25
measure: Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
timeFrame: Day 8 (baseline) and Week 49
measure: Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
timeFrame: Day 8 (baseline) and Week 97
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham 1917 Research Clinic ( Site 4031)
state: Alabama
city: Los Angeles
country: United States
facility: Men's Health Foundation ( Site 4018)
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc. ( Site 4016)
state: California
city: New Haven
country: United States
facility: Yale School of Medicine ( Site 4007)
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital ( Site 4015)
state: District of Columbia
city: Miami
country: United States
facility: The Kinder Medical Group ( Site 4014)
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center ( Site 4012)
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A. ( Site 4020)
state: Florida
city: Savannah
country: United States
facility: Chatham County Health Department ( Site 4029)
state: Georgia
city: Chicago
country: United States
facility: Howard Brown Health Center ( Site 4006)
state: Illinois
city: Chicago
country: United States
facility: Northstar Healthcare ( Site 4004)
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland ( Site 4023)
state: Maryland
city: Jackson
country: United States
facility: The University of Mississippi Medical Center ( Site 4036)
state: Mississippi
city: Newark
country: United States
facility: Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035)
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 4000)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill ( Site 4026)
state: North Carolina
city: Bellaire
country: United States
facility: Saint Hope Foundation, Inc. ( Site 4034)
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, PA ( Site 4005)
state: Texas
city: Seattle
country: United States
facility: Dr. Peter Shalit, MD ( Site 4002)
state: Washington
city: Sydney
country: Australia
facility: Holdsworth House Medical Practice ( Site 5300)
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital ( Site 5309)
state: New South Wales
city: Brisbane
country: Australia
facility: Holdsworth House Medical Practice - Brisbane ( Site 5312)
state: Queensland
city: Clayton
country: Australia
facility: Monash Health-Monash Medical Centre ( Site 5313)
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital ( Site 5304)
state: Victoria
city: Vancouver
country: Canada
facility: Vancouver ID Research and Care Centre Society ( Site 4100)
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences ( Site 4115)
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute ( Site 4111)
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network ( Site 4105)
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102)
state: Quebec
city: Temuco
country: Chile
facility: Hospital Dr. Hernan Henriquez Aravena ( Site 4405)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arriaran ( Site 4401)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Centro Cardiovascular Cardiosur ( Site 4407)
state: Region M. De Santiago
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 4301)
state: Valle Del Cauca
city: Lyon
country: France
facility: Hopital Edouard Herriot ( Site 4726)
state: Ain
city: Paris
country: France
facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724)
state: Ain
city: Nice
country: France
facility: CHU de Nice Hopital Archet 1 ( Site 4703)
state: Alpes-Maritimes
city: Marseille
country: France
facility: Hopital Europeen Marseille ( Site 4717)
state: Bouches-du-Rhone
city: Bordeaux
country: France
facility: CHU de Bordeaux- Hopital Saint Andre ( Site 4715)
state: Gironde
city: Rouen
country: France
facility: CHU de Rouen ( Site 4705)
state: Haute-Normandie
city: Montpellier
country: France
facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 4721)
state: Herault
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing ( Site 4700)
state: Nord
city: Bobigny
country: France
facility: Hopital Avicenne ( Site 4702)
state: Seine-Saint-Denis
city: Paris
country: France
facility: Hopital Hotel Dieu [Paris, France] ( Site 4723)
city: Paris
country: France
facility: A.P.H. Paris, Hopital Saint Louis ( Site 4714)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 4612)
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn ( Site 4600)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 4607)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603)
city: Berlin
country: Germany
facility: EPIMED GmbH ( Site 4608)
city: Hamburg
country: Germany
facility: ICH Study Center GmbH & Co.KG ( Site 4609)
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004)
state: Emilia-Romagna
city: Monza
country: Italy
facility: Ospedale San Gerardo ASST Monza ( Site 5012)
state: Monza E Brianza
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001)
city: Milano
country: Italy
facility: Universita' Vita Salute. Ospedale San Raffaele ( Site 5002)
city: Milano
country: Italy
facility: Azienda Ospedaliera San Paolo ( Site 5003)
city: Milano
country: Italy
facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 5000)
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo ( Site 5010)
city: Roma
country: Italy
facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005)
city: Roma
country: Italy
facility: Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006)
city: Tokyo
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine ( Site 5401)
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 5503)
state: Pusan-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 5500)
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502)
city: Lima
country: Peru
facility: INMENSA ( Site 4506)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: Via Libre ( Site 4500)
city: Lima
country: Peru
facility: Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501)
city: Guimaraes
country: Portugal
facility: Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905)
state: Braga
city: Amadora
country: Portugal
facility: Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902)
state: Lisboa
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913)
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio ( Site 4908)
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907)
city: San Juan
country: Puerto Rico
facility: HOPE Clinical Research ( Site 5700)
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101)
state: Leningradskaya Oblast
city: Moscow
country: Russian Federation
facility: Infectious Clinical Hospital #2 ( Site 5114)
state: Moskva
city: Samara
country: Russian Federation
facility: Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100)
state: Sankt-Peterburg
city: Smolensk
country: Russian Federation
facility: Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115)
state: Smolenskaya Oblast
city: Yekaterinburg
country: Russian Federation
facility: Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106)
state: Sverdlovskaya Oblast
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104)
state: Tatarstan, Respublika
city: Bloemfontein
country: South Africa
facility: FARMOVS ( Site 4805)
state: Free State
city: Johannesburg
country: South Africa
facility: Wits Clinical HIV Research Unit ( Site 4804)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Ezintsha ( Site 4806)
state: Gauteng
city: Durban
country: South Africa
facility: King Edward Hospital ( Site 4802)
state: Kwazulu-Natal
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol ( Site 5600)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial ( Site 5601)
state: Cataluna
city: Cartagena
country: Spain
facility: Hospital Santa Lucia ( Site 5603)
state: Murcia, Region De
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 5604)
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Regional Clinical Infectious Hospital ( Site 5614)
state: Kharkivska Oblast
city: Kherson
country: Ukraine
facility: Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620)
state: Khersonska Oblast
city: Kyiv
country: Ukraine
facility: Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615)
state: Kyivska Oblast
city: Mykolaiv
country: Ukraine
facility: Mykolaiv center of paliative assistance and integrated services ( Site 5621)
state: Mykolaivska Oblast
city: Odesa
country: Ukraine
facility: MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611)
state: Odeska Oblast
city: Berezina
country: Ukraine
facility: MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618)
state: Vinnytska Oblast
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital 5 ( Site 5616)
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 5202)
state: Camden
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 5201)
state: Edinburgh, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: