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Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

Primary Purpose

HIV Infection

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DOR/ISL
BIC/FTC/TAF
Placebo to BIC/FTC/TAF
Placebo to FDC DOR/ISL
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection

Eligibility Criteria

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

Inclusion Criteria:

  • Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL at screening.
  • Has been receiving BIC/FTC/TAF therapy 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 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 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

  • Pueblo Family Physicians ( Site 2717)
  • Pacific Oaks Medical Group ( Site 2765)
  • Men's Health Foundation ( Site 2749)
  • Kaiser Permanente Los Angeles Medical Center ( Site 2775)
  • Eisenhower Medical Center ( Site 2744)
  • University of California, Davis, Division of ID Research ( Site 2702)
  • Zuckerberg San Francisco General Hospital UCSF ( Site 2743)
  • Whitman-Walker Clinic ( Site 2728)
  • TheraFirst Medical Center ( Site 2742)
  • Midway Immunology and Research ( Site 2759)
  • AHF South Beach ( Site 2780)
  • The Kinder Medical Group ( Site 2739)
  • Orlando Immunology Center ( Site 2734)
  • Triple O Research Institute, P.A. ( Site 2755)
  • Augusta University ( Site 2752)
  • Infectious Disease Specialists Of Atlanta PC ( Site 2719)
  • Mercer University ( Site 2738)
  • Chatham County Health Department ( Site 2731)
  • Hennepin County Medical Center ( Site 2733)
  • Kansas City CARE Clinic ( Site 2718)
  • ID Care ( Site 2751)
  • Montefiore Einstein Center ( Site 2730)
  • Icahn School of Medicine at Mount Sinai ( Site 2700)
  • North Texas ID Consultants, PA ( Site 2707)
  • The Crofoot Research Center, Inc. ( Site 2715)
  • DCOL Center for Clinical Research ( Site 2769)
  • Dr. Peter Shalit, MD ( Site 2770)
  • Multicare Health System ( Site 2713)
  • St Vincent's Hospital ( Site 3807)
  • Taylor Square Private Clinic ( Site 3804)
  • Holdsworth House Medical Practice ( Site 3800)
  • Holdsworth House Medical Practice - Brisbane ( Site 3810)
  • Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)
  • The Alfred Hospital ( Site 3802)
  • Prahran Market Clinic (PMC) ( Site 3806)
  • LKH Graz West ( Site 3401)
  • Medical University Vienna ( Site 3402)
  • Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)
  • Social Medical Center - Otto Wagner Hospital ( Site 3404)
  • Vancouver ID Research and Care Centre Society ( Site 2800)
  • Hamilton Health Sciences ( Site 2803)
  • Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)
  • Clinique Medicale L Actuel ( Site 2814)
  • Helsinki University Hospital ( Site 3200)
  • Hopital Edouard Herriot ( Site 3126)
  • CHU de Nice Hopital Archet 1 ( Site 3103)
  • Hopital Europeen Marseille ( Site 3117)
  • Hopital Foch ( Site 3129)
  • CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)
  • CHU Hotel Dieu Nantes ( Site 3120)
  • Centre Hospitalier Regional du Orleans ( Site 3108)
  • CHU de Nancy Hopital Brabois Adultes ( Site 3128)
  • Centre Hospitalier de Tourcoing ( Site 3100)
  • Hopital Saint-Antoine ( Site 3113)
  • Hopital Pitie Salpetriere ( Site 3111)
  • Hopital Tenon ( Site 3118)
  • MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)
  • Klinikum der LMU München ( Site 3004)
  • Klinikum rechts der Isar der Technischen Universitat ( Site 3005)
  • Infektiologikum ( Site 3001)
  • Medizinische Hochschule Hannover ( Site 3012)
  • Universitaetsklinikum Bonn ( Site 3000)
  • Universitaetsklinikum Essen ( Site 3007)
  • ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)
  • EPIMED GmbH ( Site 3008)
  • ICH Study Center GmbH & Co.KG ( Site 3009)
  • Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)
  • Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)
  • Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)
  • Azienda Ospedaliera San Paolo ( Site 3503)
  • ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)
  • A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)
  • National Hospital Organization Nagoya Medical Center ( Site 7203)
  • National Hospital Organization Osaka National Hospital ( Site 7202)
  • Center Hospital of the National Center for Global Health and Medicine ( Site 7201)
  • CAIMED Center - Ponce School of Medicine ( Site 2903)
  • Puerto Rico CONCRA ( Site 2904)
  • Clinical Research Puerto Rico Inc ( Site 2900)
  • Hope Clinical Research, Inc. ( Site 2902)
  • Hospital Universitari Germans Trias i Pujol ( Site 3601)
  • Hospital Universitari Vall d Hebron ( Site 3602)
  • Hospital Universitari de Bellvitge ( Site 3612)
  • Hospital Clinic i Provincial ( Site 3600)
  • Hospital General Universitario Gregorio Maranon ( Site 3603)
  • Hospital Universitario Infanta Leonor ( Site 3606)
  • Hospital Universitario Ramon y Cajal ( Site 3611)
  • Hospital 12 de Octubre de Madrid ( Site 3605)
  • Hospital Universitario La Paz ( Site 3604)
  • Hospital Universitario Virgen de la Victoria ( Site 3609)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DOR/ISL

BIC/FTC/TAF

Arm Description

A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks.

50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156.

Outcomes

Primary Outcome Measures

Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. 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 is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.

Secondary Outcome Measures

Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented.
Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented.
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. 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 HIV-1 RNA <40 Copies/mL at Week 48
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 is presented using the FDA snapshot missing data approach.
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 is presented.
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 144 is presented.
Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Change From Baseline in CD4+ T-cell Count at Week 96
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Change From Baseline in CD4+ T-cell Count at Week 144
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Participants With Viral Drug Resistance-associated Substitutions at Week 48
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
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 demonstrate drug resistance is presented.
Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144
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 demonstrate drug resistance is presented.
Change From Baseline in Body Weight at Week 48
Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
Change From Baseline in Body Weight at Week 96
Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement.
Change From Baseline in Body Weight at Week 144
Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement.
Percentage of Participants With One or More AEs up to Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Full Information

First Posted
January 8, 2020
Last Updated
May 2, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04223791
Brief Title
Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
Official Title
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
May 31, 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
No
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 regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
643 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DOR/ISL
Arm Type
Experimental
Arm Description
A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks.
Arm Title
BIC/FTC/TAF
Arm Type
Active Comparator
Arm Description
50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156.
Intervention Type
Drug
Intervention Name(s)
DOR/ISL
Other Intervention Name(s)
MK-8591A
Intervention Description
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
Intervention Type
Drug
Intervention Name(s)
BIC/FTC/TAF
Intervention Description
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to BIC/FTC/TAF
Intervention Description
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to FDC DOR/ISL
Other Intervention Name(s)
Placebo to MK-8591A
Intervention Description
Placebo to FDC DOR/ISL in a tablet taken orally, once daily
Primary Outcome Measure Information:
Title
Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48
Description
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Time Frame
Week 48
Title
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
Time Frame
Up to 48 weeks
Title
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
Description
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented.
Time Frame
Week 96
Title
Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
Description
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented.
Time Frame
Week 144
Title
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Description
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 is presented using the FDA snapshot missing data approach
Time Frame
Week 48
Title
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
Description
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 is presented using the FDA snapshot missing data approach.
Time Frame
Week 48
Title
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 96
Description
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 is presented.
Time Frame
Week 96
Title
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 144
Description
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 144 is presented.
Time Frame
Week 144
Title
Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48
Description
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Time Frame
Baseline and Week 48
Title
Change From Baseline in CD4+ T-cell Count at Week 96
Description
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Time Frame
Baseline and Week 96
Title
Change From Baseline in CD4+ T-cell Count at Week 144
Description
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Time Frame
Baseline and Week 144
Title
Participants With Viral Drug Resistance-associated Substitutions at Week 48
Description
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Time Frame
Week 48
Title
Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
Description
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 demonstrate drug resistance is presented.
Time Frame
Week 96
Title
Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144
Description
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 demonstrate drug resistance is presented.
Time Frame
Week 144
Title
Change From Baseline in Body Weight at Week 48
Description
Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
Time Frame
Baseline and Week 48
Title
Change From Baseline in Body Weight at Week 96
Description
Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement.
Time Frame
Baseline and Week 96
Title
Change From Baseline in Body Weight at Week 144
Description
Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement.
Time Frame
Baseline and Week 144
Title
Percentage of Participants With One or More AEs up to Week 144
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to Week 144
Title
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 144
Description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time Frame
Up to Week 144

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL at screening. Has been receiving BIC/FTC/TAF therapy 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 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 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
Pueblo Family Physicians ( Site 2717)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Pacific Oaks Medical Group ( Site 2765)
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Men's Health Foundation ( Site 2749)
City
Los Angeles
State/Province
California
ZIP/Postal Code
80069
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center ( Site 2775)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Eisenhower Medical Center ( Site 2744)
City
Palm Springs
State/Province
California
ZIP/Postal Code
92264
Country
United States
Facility Name
University of California, Davis, Division of ID Research ( Site 2702)
City
Sacramento
State/Province
California
ZIP/Postal Code
95811
Country
United States
Facility Name
Zuckerberg San Francisco General Hospital UCSF ( Site 2743)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Whitman-Walker Clinic ( Site 2728)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
TheraFirst Medical Center ( Site 2742)
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Midway Immunology and Research ( Site 2759)
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
AHF South Beach ( Site 2780)
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
The Kinder Medical Group ( Site 2739)
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Orlando Immunology Center ( Site 2734)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Triple O Research Institute, P.A. ( Site 2755)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Augusta University ( Site 2752)
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Infectious Disease Specialists Of Atlanta PC ( Site 2719)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Mercer University ( Site 2738)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Chatham County Health Department ( Site 2731)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
Facility Name
Hennepin County Medical Center ( Site 2733)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Kansas City CARE Clinic ( Site 2718)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
ID Care ( Site 2751)
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Montefiore Einstein Center ( Site 2730)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai ( Site 2700)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
North Texas ID Consultants, PA ( Site 2707)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Crofoot Research Center, Inc. ( Site 2715)
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
DCOL Center for Clinical Research ( Site 2769)
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Dr. Peter Shalit, MD ( Site 2770)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Multicare Health System ( Site 2713)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
St Vincent's Hospital ( Site 3807)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Taylor Square Private Clinic ( Site 3804)
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical Practice ( Site 3800)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Holdsworth House Medical Practice - Brisbane ( Site 3810)
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
The Alfred Hospital ( Site 3802)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Prahran Market Clinic (PMC) ( Site 3806)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
LKH Graz West ( Site 3401)
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8020
Country
Austria
Facility Name
Medical University Vienna ( Site 3402)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Social Medical Center - Otto Wagner Hospital ( Site 3404)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1145
Country
Austria
Facility Name
Vancouver ID Research and Care Centre Society ( Site 2800)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Hamilton Health Sciences ( Site 2803)
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Facility Name
Clinique Medicale L Actuel ( Site 2814)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Helsinki University Hospital ( Site 3200)
City
Helsinki
State/Province
Uusimaa
ZIP/Postal Code
00029
Country
Finland
Facility Name
Hopital Edouard Herriot ( Site 3126)
City
Lyon
State/Province
Ain
ZIP/Postal Code
69003
Country
France
Facility Name
CHU de Nice Hopital Archet 1 ( Site 3103)
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06202
Country
France
Facility Name
Hopital Europeen Marseille ( Site 3117)
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13003
Country
France
Facility Name
Hopital Foch ( Site 3129)
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92151
Country
France
Facility Name
CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)
City
Montpellier
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hotel Dieu Nantes ( Site 3120)
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalier Regional du Orleans ( Site 3108)
City
Orleans
State/Province
Loiret
ZIP/Postal Code
45000
Country
France
Facility Name
CHU de Nancy Hopital Brabois Adultes ( Site 3128)
City
Vandoeuvre les Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54511
Country
France
Facility Name
Centre Hospitalier de Tourcoing ( Site 3100)
City
Tourcoing
State/Province
Nord
ZIP/Postal Code
59208
Country
France
Facility Name
Hopital Saint-Antoine ( Site 3113)
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Pitie Salpetriere ( Site 3111)
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Tenon ( Site 3118)
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80335
Country
Germany
Facility Name
Klinikum der LMU München ( Site 3004)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitat ( Site 3005)
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Infektiologikum ( Site 3001)
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Medizinische Hochschule Hannover ( Site 3012)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitaetsklinikum Bonn ( Site 3000)
City
Bonn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Essen ( Site 3007)
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Facility Name
EPIMED GmbH ( Site 3008)
City
Berlin
ZIP/Postal Code
12167
Country
Germany
Facility Name
ICH Study Center GmbH & Co.KG ( Site 3009)
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)
City
Milano
ZIP/Postal Code
20127
Country
Italy
Facility Name
Azienda Ospedaliera San Paolo ( Site 3503)
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center ( Site 7203)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital ( Site 7202)
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine ( Site 7201)
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
CAIMED Center - Ponce School of Medicine ( Site 2903)
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Puerto Rico CONCRA ( Site 2904)
City
Rio Piedras
ZIP/Postal Code
00925
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico Inc ( Site 2900)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Hope Clinical Research, Inc. ( Site 2902)
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Hospital Universitari Germans Trias i Pujol ( Site 3601)
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitari Vall d Hebron ( Site 3602)
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari de Bellvitge ( Site 3612)
City
LHospitalet de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clinic i Provincial ( Site 3600)
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon ( Site 3603)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor ( Site 3606)
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal ( Site 3611)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre de Madrid ( Site 3605)
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz ( Site 3604)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria ( Site 3609)
City
Malaga
ZIP/Postal Code
29010
Country
Spain

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

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

We'll reach out to this number within 24 hrs