Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1, Group 1: ISL + ART HTE participants with HIV-1 infection take ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7 in Part 1. |
Drug: ISL
ISL 0.75 mg capsule taken by mouth.
Other Names:
|
| Experimental: Part 1, Group 2: DOR + ART HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7 in Part 1. |
Drug: DOR
DOR 100 mg tablet taken by mouth.
Other Names:
|
| Experimental: Part 1, Group 3: DOR/ISL + ART HTE participants with HIV-1 infection take 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7 in Part 1. |
Drug: DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Other Names:
|
| Placebo Comparator: Part 1, Group 4: Placebo + ART HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7 in Part 1. |
Drug: Placebo to ISL
Placebo capsule matched to ISL taken by mouth.
Drug: Placebo to DOR
Placebo tablet matched to DOR taken by mouth.
|
| Experimental: Part 2, Group 5: Open-Label DOR/ISL + OBT HTE participants from Groups 1 to 4 with HIV-1 infection take open-label 100 mg DOR/0.75 mg ISL + OBT in Part 2 (Day 8 to Week 97). |
Drug: DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants receiving doravirine/islatravir (DOR/ISL) with ≥0.5 log10 decrease from baseline in human immunodificiency virus type 1 (HIV-1) ribonucleic acid (RNA) compared to placebo treatment [Day 1 (baseline) and Day 8]
The change from baseline in HIV-1 RNA will be determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL.
- Percentage of participants with ≥1 adverse events (AEs) [Up to 49 weeks]
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
- Percentage of participants withdrawing from study treatment due to AE(s) [Up to 49 weeks]
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Secondary Outcome Measures
- Percentage of participants with ≥1 adverse events (AEs) [Up to 97 weeks]
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.
- Percentage of participants discontinuing from study therapy due to AE(s) [Up to 97 weeks]
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.
- Percentage of participants receiving DOR or ISL (given with antiretoviral therapy [ART]) with ≥0.5 log10 decrease in HIV-1 RNA compared to placebo treatment [Day 1 (baseline) and Day 8]
The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment [Day 1 (baseline) and Day 8]
The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART), DOR, or ISL with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to placebo treatment [Day 1 (baseline) and Day 8]
The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 1 (baseline) and Day 8]
The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment [Day 1 (baseline) and Day 8]
The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 1 (baseline) and Day 8]
The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 8 (baseline) and Week 25]
The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 1 (baseline) and Week 49]
The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 1 (baseline) and Week 97]
The percentage of participants with ≥0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 8 (baseline) and Week 25]
The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 1 (baseline) and Week 49]
The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with ≥1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment [Day 1 (baseline) and Week 97]
The percentage of participants with ≥1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT [Day 8 (baseline) and Week 25]
The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT [Day 1 (baseline) and Week 49]
The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT [Day 8 (baseline) and Week 97]
The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL [Day 8 (baseline) and Week 25]
The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL [Day 1 (baseline) and Week 49]
The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL [Day 1 (baseline) and Week 97]
The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL [Day 8 (baseline) and Week 25]
The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL [Day 1 (baseline) and Week 49]
The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL [Day 1 (baseline) and Week 97]
The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL [Day 8 (baseline) and Week 25]
The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL [Day 1 (baseline) and Week 49]
The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL [Day 1 (baseline) and Week 97]
The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
- Prevalence of viral drug resistance to DOR [Week 25]
The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
- Prevalence of viral drug resistance to DOR [Week 49]
The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
- Prevalence of viral drug resistance to ISL [Week 25]
The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
- Prevalence of viral drug resistance to ISL [Week 49]
The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
- Prevalence of viral drug resistance to optimized background therapy (OBT) components [Week 25]
The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
- Prevalence of viral drug resistance to OBT components [Week 49]
The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
- Role of baseline antiviral resistance on viral resistance-associated substitutions (RASs) [Day 1 (baseline) and Week 25]
The role of baseline antiviral resistance on viral RAS will be determined.
- Role of baseline antiviral resistance on viral RASs [Day 1 (baseline) and Week 49]
The role of baseline antiviral resistance on viral RAS will be determined.
- Role of baseline antiviral resistance on viral RASs [Day 1 (baseline) and Week 97]
The role of baseline antiviral resistance on viral RAS will be determined.
- Role of baseline antiviral resistance on HIV-1 RNA [Day 8 (baseline) and Week 25]
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
- Role of baseline antiviral resistance on HIV-1 RNA [Day 8 (baseline) and Week 49]
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
- Role of baseline antiviral resistance on HIV-1 RNA [Day 8 (baseline) and Week 97]
The role of baseline antiviral resistance on HIV-1 RNA will be determined.
- Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts [Day 1 (baseline) and Week 25]
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
- Change from baseline in CD4+ T-cell counts [Day 1 (baseline) and Week 49]
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
- Change from baseline in CD4+ T-cell counts [Day 1 (baseline) and Week 97]
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
- Change from baseline in CD4+ T-cell counts [Day 8 (baseline) and Week 25]
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
- Change from baseline in CD4+ T-cell counts [Day 8 (baseline) and Week 49]
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
- Change from baseline in CD4+ T-cell counts [Day 8 (baseline) and Week 97]
The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham 1917 Research Clinic ( Site 4031) | Birmingham | Alabama | United States | 35222 |
| 2 | Men's Health Foundation ( Site 4018) | Los Angeles | California | United States | 90069 |
| 3 | Palmtree Clinical Research, Inc. ( Site 4016) | Palm Springs | California | United States | 92262 |
| 4 | Yale School of Medicine ( Site 4007) | New Haven | Connecticut | United States | 06510 |
| 5 | Georgetown University Hospital ( Site 4015) | Washington | District of Columbia | United States | 20007 |
| 6 | The Kinder Medical Group ( Site 4014) | Miami | Florida | United States | 33133 |
| 7 | Orlando Immunology Center ( Site 4012) | Orlando | Florida | United States | 32803 |
| 8 | Triple O Research Institute, P.A. ( Site 4020) | West Palm Beach | Florida | United States | 33407 |
| 9 | Chatham County Health Department ( Site 4029) | Savannah | Georgia | United States | 31410 |
| 10 | Howard Brown Health Center ( Site 4006) | Chicago | Illinois | United States | 60613 |
| 11 | Northstar Healthcare ( Site 4004) | Chicago | Illinois | United States | 60657 |
| 12 | University of Maryland ( Site 4023) | Baltimore | Maryland | United States | 21201 |
| 13 | The University of Mississippi Medical Center ( Site 4036) | Jackson | Mississippi | United States | 39216 |
| 14 | Saint Michael's Medical Center-Research - Infectious Disease ( Site 4035) | Newark | New Jersey | United States | 07102 |
| 15 | Icahn School of Medicine at Mount Sinai ( Site 4000) | New York | New York | United States | 10029 |
| 16 | University of North Carolina at Chapel Hill ( Site 4026) | Chapel Hill | North Carolina | United States | 27599 |
| 17 | Saint Hope Foundation, Inc. ( Site 4034) | Bellaire | Texas | United States | 77401 |
| 18 | North Texas Infectious Diseases Consultants, PA ( Site 4005) | Dallas | Texas | United States | 75246 |
| 19 | Dr. Peter Shalit, MD ( Site 4002) | Seattle | Washington | United States | 98104 |
| 20 | Holdsworth House Medical Practice ( Site 5300) | Sydney | New South Wales | Australia | 2000 |
| 21 | St Vincent's Hospital ( Site 5309) | Sydney | New South Wales | Australia | 2010 |
| 22 | Holdsworth House Medical Practice - Brisbane ( Site 5312) | Brisbane | Queensland | Australia | 4006 |
| 23 | Monash Health-Monash Medical Centre ( Site 5313) | Clayton | Victoria | Australia | 3168 |
| 24 | The Alfred Hospital ( Site 5304) | Melbourne | Victoria | Australia | 3004 |
| 25 | Vancouver ID Research and Care Centre Society ( Site 4100) | Vancouver | British Columbia | Canada | V6Z 2C7 |
| 26 | Hamilton Health Sciences ( Site 4115) | Hamilton | Ontario | Canada | L8L 2X2 |
| 27 | Ottawa Hospital Research Institute ( Site 4111) | Ottawa | Ontario | Canada | K1H 8L6 |
| 28 | Toronto General Hospital - University Health Network ( Site 4105) | Toronto | Ontario | Canada | M5G 2N2 |
| 29 | McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 4102) | Montreal | Quebec | Canada | H4A 3J1 |
| 30 | Hospital Dr. Hernan Henriquez Aravena ( Site 4405) | Temuco | Araucania | Chile | 4781151 |
| 31 | Fundacion Arriaran ( Site 4401) | Santiago | Region M. De Santiago | Chile | 8360159 |
| 32 | Centro Cardiovascular Cardiosur ( Site 4407) | Santiago | Region M. De Santiago | Chile | 8910259 |
| 33 | Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 4306) | Bogota | Distrito Capital De Bogota | Colombia | 111321 |
| 34 | Fundacion Valle del Lili ( Site 4301) | Cali | Valle Del Cauca | Colombia | 760032 |
| 35 | Hopital Edouard Herriot ( Site 4726) | Lyon | Ain | France | 69003 |
| 36 | A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 4724) | Paris | Ain | France | 75018 |
| 37 | CHU de Nice Hopital Archet 1 ( Site 4703) | Nice | Alpes-Maritimes | France | 06202 |
| 38 | Hopital Europeen Marseille ( Site 4717) | Marseille | Bouches-du-Rhone | France | 13003 |
| 39 | CHU de Bordeaux- Hopital Saint Andre ( Site 4715) | Bordeaux | Gironde | France | 33075 |
| 40 | CHU de Rouen ( Site 4705) | Rouen | Haute-Normandie | France | 76031 |
| 41 | CHU de Montpellier - Hopital Saint-Eloi ( Site 4721) | Montpellier | Herault | France | 34295 |
| 42 | Centre Hospitalier de Tourcoing ( Site 4700) | Tourcoing | Nord | France | 59208 |
| 43 | Hopital Avicenne ( Site 4702) | Bobigny | Seine-Saint-Denis | France | 93000 |
| 44 | Hopital Hotel Dieu [Paris, France] ( Site 4723) | Paris | France | 75004 | |
| 45 | A.P.H. Paris, Hopital Saint Louis ( Site 4714) | Paris | France | 75010 | |
| 46 | Medizinische Hochschule Hannover ( Site 4612) | Hannover | Niedersachsen | Germany | 30625 |
| 47 | Universitaetsklinikum Bonn ( Site 4600) | Bonn | Nordrhein-Westfalen | Germany | 53127 |
| 48 | Universitaetsklinikum Essen ( Site 4607) | Essen | Nordrhein-Westfalen | Germany | 45122 |
| 49 | ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 4603) | Berlin | Germany | 10439 | |
| 50 | EPIMED GmbH ( Site 4608) | Berlin | Germany | 10787 | |
| 51 | ICH Study Center GmbH & Co.KG ( Site 4609) | Hamburg | Germany | 20146 | |
| 52 | Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 5004) | Modena | Emilia-Romagna | Italy | 41124 |
| 53 | Ospedale San Gerardo ASST Monza ( Site 5012) | Monza | Monza E Brianza | Italy | 20900 |
| 54 | Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 5001) | Milano | Italy | 20122 | |
| 55 | Universita' Vita Salute. Ospedale San Raffaele ( Site 5002) | Milano | Italy | 20127 | |
| 56 | Azienda Ospedaliera San Paolo ( Site 5003) | Milano | Italy | 20142 | |
| 57 | ASST Fatebenefratelli-Ospedale Sacco ( Site 5000) | Milano | Italy | 20157 | |
| 58 | IRCCS Policlinico San Matteo ( Site 5010) | Pavia | Italy | 27100 | |
| 59 | Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 5005) | Roma | Italy | 00149 | |
| 60 | Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 5006) | Roma | Italy | 00168 | |
| 61 | Center Hospital of the National Center for Global Health and Medicine ( Site 5401) | Tokyo | Japan | 162-8655 | |
| 62 | Pusan National University Hospital ( Site 5503) | Busan | Pusan-Kwangyokshi | Korea, Republic of | 49241 |
| 63 | Severance Hospital Yonsei University Health System ( Site 5500) | Seoul | Korea, Republic of | 03722 | |
| 64 | The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 5502) | Seoul | Korea, Republic of | 06591 | |
| 65 | INMENSA ( Site 4506) | Lima | Muni Metro De Lima | Peru | 15046 |
| 66 | Via Libre ( Site 4500) | Lima | Peru | 15001 | |
| 67 | Policlinico Universidad Nacional Mayor de San Marcos ( Site 4501) | Lima | Peru | 15081 | |
| 68 | Hospital de Nossa Senhora da Oliveira- EPE ( Site 4905) | Guimaraes | Braga | Portugal | 4835-044 |
| 69 | Hospital Dr. Fernando Fonseca, EPE - Amadora/Sintra ( Site 4902) | Amadora | Lisboa | Portugal | 2720-276 |
| 70 | Centro Hospitalar de Lisboa Norte Hospital de Santa Maria ( Site 4913) | Lisboa | Portugal | 1649-035 | |
| 71 | Hospital Geral de Santo Antonio ( Site 4908) | Porto | Portugal | 4099-001 | |
| 72 | Centro Hospitalar de Sao Joao. EPE - Hospital de Sao Joao ( Site 4907) | Porto | Portugal | 4200-319 | |
| 73 | HOPE Clinical Research ( Site 5700) | San Juan | Puerto Rico | 00909 | |
| 74 | Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 5101) | Saint Petersburg | Leningradskaya Oblast | Russian Federation | |
| 75 | Infectious Clinical Hospital #2 ( Site 5114) | Moscow | Moskva | Russian Federation | 105275 |
| 76 | Gbuz Samarskiy Oblastnoy Klinicheskiy Tsentr Profilaktiki I Bor'by So Spid ( Site 5113) | Samara | Samarskaya Oblast | Russian Federation | 443124 |
| 77 | FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 5100) | Saint Petersburg | Sankt-Peterburg | Russian Federation | 196645 |
| 78 | Smolensk Center On Aids And Infectious Diseases Prophylaxis ( Site 5115) | Smolensk | Smolenskaya Oblast | Russian Federation | 214006 |
| 79 | Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 5106) | Yekaterinburg | Sverdlovskaya Oblast | Russian Federation | 620102 |
| 80 | Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 5104) | Kazan | Tatarstan, Respublika | Russian Federation | 420140 |
| 81 | FARMOVS ( Site 4805) | Bloemfontein | Free State | South Africa | 9301 |
| 82 | Wits Clinical HIV Research Unit ( Site 4804) | Johannesburg | Gauteng | South Africa | 2041 |
| 83 | Ezintsha ( Site 4806) | Johannesburg | Gauteng | South Africa | 2193 |
| 84 | King Edward Hospital ( Site 4802) | Durban | Kwazulu-Natal | South Africa | 4013 |
| 85 | Hospital Universitari Germans Trias i Pujol ( Site 5600) | Badalona | Barcelona | Spain | 08916 |
| 86 | Hospital Clinic i Provincial ( Site 5601) | Barcelona | Cataluna | Spain | 08036 |
| 87 | Hospital Santa Lucia ( Site 5603) | Cartagena | Murcia, Region De | Spain | 30202 |
| 88 | Hospital Universitario La Paz ( Site 5604) | Madrid | Spain | 28046 | |
| 89 | Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 5619) | Dnipro | Dnipropetrovska Oblast | Ukraine | 49115 |
| 90 | Regional Clinical Infectious Hospital ( Site 5614) | Kharkiv | Kharkivska Oblast | Ukraine | 61096 |
| 91 | Kherson City Clinical Hospital n.a. Y.Y. Karabelesh ( Site 5620) | Kherson | Khersonska Oblast | Ukraine | 73000 |
| 92 | Institute of Epidemiology and Infect Diseases of the NAMS of Ukraine ( Site 5615) | Kyiv | Kyivska Oblast | Ukraine | 03038 |
| 93 | Mykolaiv center of paliative assistance and integrated services ( Site 5621) | Mykolaiv | Mykolaivska Oblast | Ukraine | 54003 |
| 94 | MNE Odesa Regional Center of Socially Significant Diseases ( Site 5611) | Odesa | Odeska Oblast | Ukraine | 65014 |
| 95 | MI Vinnytsia Regional Center of AIDS Prevention and Care ( Site 5618) | Berezina | Vinnytska Oblast | Ukraine | 23222 |
| 96 | Kyiv City Clinical Hospital 5 ( Site 5616) | Kyiv | Ukraine | 03115 | |
| 97 | Royal Free Hospital ( Site 5202) | London | Camden | United Kingdom | NW3 2QG |
| 98 | Western General Hospital ( Site 5201) | Edinburgh | Edinburgh, City Of | United Kingdom | EH4 2XU |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8591A-019
- MK-8591A-019
- 205243
- 2019-000588-26