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Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Primary Purpose

HIV Infection

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

DOR/ISL

ART

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 HIV-1 positive
Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive

Exclusion Criteria:

Has HIV-2 infection
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
Is currently taking long-acting cabotegravir-rilpivirine
Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period
Has a documented or known virologic resistance to DOR
Female expects to conceive or donate eggs at any time during the study

Sites / Locations

Georgetown University Hospital ( Site 1018)
Midway Immunology and Research ( Site 1030)
Orlando Immunology Center ( Site 1007)
Bliss Healthcare Services ( Site 1025)
Triple O Research Institute, P.A. ( Site 1026)
Chatham County Health Department ( Site 1043)
Northstar Healthcare ( Site 1002)
Kansas City CARE Health Center ( Site 1008)
ID Care ( Site 1023)
University of North Carolina at Chapel Hill ( Site 1042)
University of Pennsylvania ( Site 1038)
Saint Hope Foundation, Inc. ( Site 1037)
North Texas ID Consultants, PA ( Site 1003)
Texas Centers for Infectious Disease Associates P.A. ( Site 1022)
The Crofoot Research Center, Inc. ( Site 1005)
Holdsworth House Medical Practice ( Site 2300)
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)
Melbourne Sexual Health Centre ( Site 2305)
Fiona Stanley Hospital ( Site 2301)
Southern Alberta HIV Clinic ( Site 1108)
Vancouver ID Research and Care Centre Society ( Site 1100)
Hamilton Health Sciences ( Site 1103)
Maple Leaf Research ( Site 1112)
Toronto General Hospital - University Health Network ( Site 1105)
Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)
Clinique Medicale L Actuel ( Site 1114)
Hospital Dr. Hernan Henriquez Aravena ( Site 1305)
Clinica Arauco Salud ( Site 1300)
Centro de Investigacion Clinica UC CICUC ( Site 1303)
Fundacion Valle del Lili ( Site 1201)
Hopital Francois Mitterrand ( Site 2019)
CHU de Bordeaux- Hopital Saint Andre ( Site 2015)
CHU de Toulouse - Hopital Purpan ( Site 2004)
CHU Hotel Dieu Nantes ( Site 2020)
Hopital de la Croix-Rousse ( Site 2027)
CHU de Rouen ( Site 2005)
A.P.H. Paris, Hopital Saint Louis ( Site 2014)
ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)
Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)
National Hospital Organization Nagoya Medical Center ( Site 2403)
National Hospital Organization Osaka National Hospital ( Site 2402)
Tokyo Metropolitan Komagome Hospital ( Site 2406)
Tokyo Medical University Hospital ( Site 2404)
Center Hospital of the National Center for Global Health and Medicine ( Site 2401)
Christchurch Hospital ( Site 2303)
EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)
Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)
SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)
Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)
Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)
Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)
Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)
Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)
Infectious Clinical Hospital #2 ( Site 1719)
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)
Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)
JOSHA Research ( Site 1406)
Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)
Hospital General de Elche ( Site 1608)
Hospital Universitari Germans Trias i Pujol ( Site 1606)
Hospital Clinic i Provincial ( Site 1600)
Hospital General Universitario Gregorio Maranon ( Site 1603)
Hospital Universitario Infanta Leonor ( Site 1601)
Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)
Hospital Universitario La Paz ( Site 1604)
Universitaetsspital Basel ( Site 3302)
Inselspital Universitaetsspital Bern ( Site 3303)
Hopitaux Universitaires de Geneve HUG. ( Site 3304)
Kantonsspital St. Gallen ( Site 3301)
Ospedale Regionale di Lugano Civico ( Site 3305)
Universitaetsspital Zuerich ( Site 3300)
Brighton and Sussex University Hospital NHS Trust ( Site 1908)
Southmead Hospital ( Site 1910)
Royal Free Hospital ( Site 1904)
Kings College Hospital NHS Foundation Trust ( Site 1907)
North Manchester General Hospital ( Site 1902)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Doravirine/Islatravir (DOR/ISL)

Baseline Background Antiretroviral Therapy (ART)

Arm Description

Participants who were previously treated with continuous background antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.

Participants will receive continuous background ART for 48 weeks and DOR/ISL, a FDC of 100 mg DOR/0.75 mg ISL orally once daily for 48 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48

HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.

Percentage of Participants With One or More Adverse Events (AEs) up to Week 48

An AE was defined as 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. The percentage of participants who experienced at least one AE was reported.

Percentage of Participants Who Discontinued Study Intervention up to Week 48

Secondary Outcome Measures

Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48

HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA <40 copies/mL or <50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.

Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL From Week 48 to Week 96

HIV-1 RNA levels in blood samples taken at each visit will be measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL, or <50 copies/mL from Week 48 to Week 96 will be presented using the FDA Snapshot missing data approach.

Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96

HIV-1 RNA levels in blood samples taken at each visit will be measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL, or <50 copies/mL at Week 96 will be presented using the FDA Snapshot missing data approach.

Percentage Change From Baseline in CD4+ T-cell Count at Week 48

Plasma CD4+ T-Cell Count was measured in cells/mm^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The percentage change from baseline to Week 48 is presented.

Percentage Change From Baseline in CD4+ T-cell Count at Week 96

Plasma CD4+ T-Cell Count will be measured in cells/mm^3 for baseline and 96 weeks. Baseline measurements will be defined as the Day 1 value of each participant. The percentage change from baseline to Week 96 will be presented.

Percentage Change From Week 48 in CD4+ T-cell Count at Week 96

Plasma CD4+ T-Cell Count will be measured in cells/mm^3 for Week 48 and Week 96. The percentage change from Week 48 to Week 96 will be presented.

Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48

Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated drug resistance at Week 48 is presented.

Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96

Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)

Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.

Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)

Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.

Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens

Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.

Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)

Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.

Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)

Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.

Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens

Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.

Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens)

Baseline measurements were defined as the Day 1 value of each participant. The change from baseline to Week 48 is presented for participants who received InSTI- based regimens.

Percentage of Participants With One or More AEs up to Week 96

An AE is defined as 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. The percentage of participants who experience at least one AE will be reported.

Percentage of Participants Who Discontinued Study Intervention up to Week 96

Percentage of Participants With One or More AEs From Week 48 to Week 96

Percentage of Participants Who Discontinued Study Intervention From Week 48 to Week 96

Full Information

NCT ID

NCT04223778

First Posted

January 8, 2020

Last Updated

November 3, 2022

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04223778

Brief Title

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Official Title

A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 18, 2020 (Actual)

Primary Completion Date

September 8, 2021 (Actual)

Study Completion Date

March 30, 2024 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified background antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

672 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Doravirine/Islatravir (DOR/ISL)

Arm Type

Experimental

Arm Description

Arm Title

Baseline Background Antiretroviral Therapy (ART)

Arm Type

Active Comparator

Arm Description

Participants will receive continuous background ART for 48 weeks and DOR/ISL, a FDC of 100 mg DOR/0.75 mg ISL orally once daily for 48 weeks.

Intervention Type

Drug

Intervention Name(s)

DOR/ISL

Other Intervention Name(s)

MK-8591A

Intervention Description

A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily

Intervention Type

Drug

Intervention Name(s)

ART

Intervention Description

Baseline background ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.

Primary Outcome Measure Information:

Title

Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48

Description

Time Frame

Week 48

Title

Percentage of Participants With One or More Adverse Events (AEs) up to Week 48

Description

Time Frame

Up to ~48 Weeks

Title

Percentage of Participants Who Discontinued Study Intervention up to Week 48

Description

Time Frame

Up to ~48 Weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48

Description

Time Frame

Week 48

Title

Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL From Week 48 to Week 96

Description

Time Frame

Weeks 48-96 (up to ~48 weeks)

Title

Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96

Description

HIV-1 RNA levels in blood samples taken at each visit will be measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL, or <50 copies/mL at Week 96 will be presented using the FDA Snapshot missing data approach.

Time Frame

Week 96

Title

Percentage Change From Baseline in CD4+ T-cell Count at Week 48

Description

Time Frame

Baseline and Week 48

Title

Percentage Change From Baseline in CD4+ T-cell Count at Week 96

Description

Time Frame

Baseline and Week 96

Title

Percentage Change From Week 48 in CD4+ T-cell Count at Week 96

Description

Plasma CD4+ T-Cell Count will be measured in cells/mm^3 for Week 48 and Week 96. The percentage change from Week 48 to Week 96 will be presented.

Time Frame

Week 48 and Week 96

Title

Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48

Description

Time Frame

Week 48

Title

Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96

Description

Time Frame

Week 96

Title

Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)

Description

Time Frame

Baseline and Week 48

Title

Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)

Description

Time Frame

Baseline and Week 48

Title

Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens

Description

Time Frame

Baseline and Week 48

Title

Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens)

Description

Baseline measurements were defined as the Day 1 value of each participant. The change from baseline to Week 48 is presented for participants who received InSTI- based regimens.

Time Frame

Baseline and Week 48

Title

Percentage of Participants With One or More AEs up to Week 96

Description

Time Frame

Up to ~96 Weeks

Title

Percentage of Participants Who Discontinued Study Intervention up to Week 96

Description

Time Frame

Up to ~96 Weeks

Title

Percentage of Participants With One or More AEs From Week 48 to Week 96

Description

Time Frame

Weeks 48-96

Title

Percentage of Participants Who Discontinued Study Intervention From Week 48 to Week 96

Description

Time Frame

Weeks 48-96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Is HIV-1 positive Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen. Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive Exclusion Criteria: Has HIV-2 infection Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies Is currently taking long-acting cabotegravir-rilpivirine Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period Has a documented or known virologic resistance to DOR Female expects to conceive or donate eggs at any time during the study

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

Georgetown University Hospital ( Site 1018)

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Midway Immunology and Research ( Site 1030)

City

Fort Pierce

State/Province

Florida

ZIP/Postal Code

34982

Country

United States

Facility Name

Orlando Immunology Center ( Site 1007)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Bliss Healthcare Services ( Site 1025)

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Triple O Research Institute, P.A. ( Site 1026)

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Chatham County Health Department ( Site 1043)

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31401

Country

United States

Facility Name

Northstar Healthcare ( Site 1002)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60657

Country

United States

Facility Name

Kansas City CARE Health Center ( Site 1008)

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64111

Country

United States

Facility Name

ID Care ( Site 1023)

City

Hillsborough

State/Province

New Jersey

ZIP/Postal Code

08844

Country

United States

Facility Name

University of North Carolina at Chapel Hill ( Site 1042)

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

University of Pennsylvania ( Site 1038)

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Saint Hope Foundation, Inc. ( Site 1037)

City

Bellaire

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

North Texas ID Consultants, PA ( Site 1003)

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Texas Centers for Infectious Disease Associates P.A. ( Site 1022)

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

The Crofoot Research Center, Inc. ( Site 1005)

City

Houston

State/Province

Texas

ZIP/Postal Code

77098

Country

United States

Facility Name

Holdsworth House Medical Practice ( Site 2300)

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309)

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Melbourne Sexual Health Centre ( Site 2305)

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

Fiona Stanley Hospital ( Site 2301)

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

Southern Alberta HIV Clinic ( Site 1108)

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2R 0X7

Country

Canada

Facility Name

Vancouver ID Research and Care Centre Society ( Site 1100)

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 2C7

Country

Canada

Facility Name

Hamilton Health Sciences ( Site 1103)

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Maple Leaf Research ( Site 1112)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1K2

Country

Canada

Facility Name

Toronto General Hospital - University Health Network ( Site 1105)

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2N2

Country

Canada

Facility Name

Clinique de Medecine Urbaine du Quartier Latin ( Site 1104)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4E9

Country

Canada

Facility Name

Clinique Medicale L Actuel ( Site 1114)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4P9

Country

Canada

Facility Name

Hospital Dr. Hernan Henriquez Aravena ( Site 1305)

City

Temuco

State/Province

Araucania

ZIP/Postal Code

4781151

Country

Chile

Facility Name

Clinica Arauco Salud ( Site 1300)

City

Santiago

State/Province

Region Metropolitana De Santiago

ZIP/Postal Code

7560994

Country

Chile

Facility Name

Centro de Investigacion Clinica UC CICUC ( Site 1303)

City

Santiago

State/Province

Region Metropolitana De Santiago

ZIP/Postal Code

8330034

Country

Chile

Facility Name

Fundacion Valle del Lili ( Site 1201)

City

Cali

State/Province

Valle Del Cauca

ZIP/Postal Code

760032

Country

Colombia

Facility Name

Hopital Francois Mitterrand ( Site 2019)

City

Dijon

State/Province

Cote-d'Or

ZIP/Postal Code

21079

Country

France

Facility Name

CHU de Bordeaux- Hopital Saint Andre ( Site 2015)

City

Bordeaux

State/Province

Gironde

ZIP/Postal Code

33075

Country

France

Facility Name

CHU de Toulouse - Hopital Purpan ( Site 2004)

City

Toulouse

State/Province

Haute-Garonne

ZIP/Postal Code

31059

Country

France

Facility Name

CHU Hotel Dieu Nantes ( Site 2020)

City

Nantes

State/Province

Loire-Atlantique

ZIP/Postal Code

44093

Country

France

Facility Name

Hopital de la Croix-Rousse ( Site 2027)

City

Lyon

State/Province

Rhone-Alpes

ZIP/Postal Code

69317

Country

France

Facility Name

CHU de Rouen ( Site 2005)

City

Rouen

State/Province

Seine-Maritime

ZIP/Postal Code

76031

Country

France

Facility Name

A.P.H. Paris, Hopital Saint Louis ( Site 2014)

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

ASST Fatebenefratelli-Ospedale Sacco ( Site 2200)

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 2208)

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Policlinico Gemelli Instituto di Clinica Chirurgica ( Site 2206)

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

National Hospital Organization Nagoya Medical Center ( Site 2403)

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

National Hospital Organization Osaka National Hospital ( Site 2402)

City

Osaka

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

Tokyo Metropolitan Komagome Hospital ( Site 2406)

City

Tokyo

ZIP/Postal Code

113-8677

Country

Japan

Facility Name

Tokyo Medical University Hospital ( Site 2404)

City

Tokyo

ZIP/Postal Code

160-0023

Country

Japan

Facility Name

Center Hospital of the National Center for Global Health and Medicine ( Site 2401)

City

Tokyo

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Christchurch Hospital ( Site 2303)

City

Christchurch

State/Province

Canterbury

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

EMC Instytut Medyczny SA Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1500)

City

Wroclaw

State/Province

Dolnoslaskie

ZIP/Postal Code

50-220

Country

Poland

Facility Name

Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 1503)

City

Lodz-Baluty

State/Province

Lodzkie

ZIP/Postal Code

91-347

Country

Poland

Facility Name

SP ZOZ Wojewodzki Szpital Zakazny ( Site 1505)

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

01-201

Country

Poland

Facility Name

Wroclawskie Centrum Zdrowia SP ZOZ ( Site 1507)

City

Wroclaw

ZIP/Postal Code

50-136

Country

Poland

Facility Name

Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713)

City

Kemerovo

State/Province

Kemerovskaya Oblast'

ZIP/Postal Code

650056

Country

Russian Federation

Facility Name

Krasnoyarsk Regional Center for Prevention and Control of AIDS ( Site 1712)

City

Krasnoyarsk

State/Province

Krasnoyarskiy Kray

ZIP/Postal Code

660049

Country

Russian Federation

Facility Name

Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701)

City

Saint Petersburg

State/Province

Leningradskaya Oblast'

ZIP/Postal Code

190020

Country

Russian Federation

Facility Name

Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

105275

Country

Russian Federation

Facility Name

Infectious Clinical Hospital #2 ( Site 1719)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

105275

Country

Russian Federation

Facility Name

FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

196645

Country

Russian Federation

Facility Name

Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715)

City

Yekaterinburg

State/Province

Sverdlovskaya Oblast'

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707)

City

Kazan

State/Province

Tatarstan, Respublika

ZIP/Postal Code

420140

Country

Russian Federation

Facility Name

JOSHA Research ( Site 1406)

City

Bloemfontein

State/Province

Free State

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1414)

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Hospital General de Elche ( Site 1608)

City

Elche

State/Province

Alicante

ZIP/Postal Code

03202

Country

Spain

Facility Name

Hospital Universitari Germans Trias i Pujol ( Site 1606)

City

Badalona

State/Province

Barcelona [Barcelona]

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hospital Clinic i Provincial ( Site 1600)

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital General Universitario Gregorio Maranon ( Site 1603)

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hospital Universitario Infanta Leonor ( Site 1601)

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Hospital Universitario Fundacion Jimenez Diaz ( Site 1602)

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario La Paz ( Site 1604)

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Universitaetsspital Basel ( Site 3302)

City

Basel

State/Province

Basel-Stadt

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Inselspital Universitaetsspital Bern ( Site 3303)

City

Bern

State/Province

Berne

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Hopitaux Universitaires de Geneve HUG. ( Site 3304)

City

Geneva

State/Province

Geneve

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Kantonsspital St. Gallen ( Site 3301)

City

St. Gallen

State/Province

Sankt Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Ospedale Regionale di Lugano Civico ( Site 3305)

City

Lugano

State/Province

Ticino

ZIP/Postal Code

6903

Country

Switzerland

Facility Name

Universitaetsspital Zuerich ( Site 3300)

City

Zuerich

State/Province

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Brighton and Sussex University Hospital NHS Trust ( Site 1908)

City

Brighton

State/Province

Brighton And Hove

ZIP/Postal Code

BN2 1ES

Country

United Kingdom

Facility Name

Southmead Hospital ( Site 1910)

City

Bristol

State/Province

Bristol, City Of

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

Facility Name

Royal Free Hospital ( Site 1904)

City

London

State/Province

Camden

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Kings College Hospital NHS Foundation Trust ( Site 1907)

City

London

State/Province

London, City Of

ZIP/Postal Code

SE5 9RJ

Country

United Kingdom

Facility Name

North Manchester General Hospital ( Site 1902)

City

Manchester

ZIP/Postal Code

M8 5RB

Country

United Kingdom

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

Learn more about this trial

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

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