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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223778
Recruitment Status : Active, not recruiting
First Posted : January 10, 2020
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 8, 2020
First Posted Date  ICMJE January 10, 2020
Last Update Posted Date October 11, 2021
Actual Study Start Date  ICMJE February 18, 2020
Actual Primary Completion Date September 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • Participants with HIV-1 RNA ≥50 copies/mL [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48
  • Participants with one or more adverse events (AEs) up to Week 48 [ Time Frame: Day 1 to Week 48 ]
    Percentage of participants with one or more adverse events (AEs) up to Week 48
  • Participants who discontinued study intervention up to Week 48 [ Time Frame: Day 1 to Week 48 ]
    Percentage of participants who discontinued study intervention due to an AE up to Week 48
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • Participants with HIV-1 RNA <40 or <50 copies/mL [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 48
  • Participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL from Week 48 to Week 96
  • Participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL from Day 1 to Week 96
  • Change from baseline in CD4+ T-cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in cluster of differentiation 4+ (CD4+) T-cell count at Week 48
  • Change from baseline in CD4+ T-cell count at Week 96 [ Time Frame: Baseline and Week 96 ]
    Change from baseline in CD4+ T-cell count at Week 96
  • Change from Week 48 in CD4+ T-cell count at Week 96 [ Time Frame: Week 48 and Week 96 ]
    Change from Week 48 in CD4+ T-cell count at Week 96
  • Participants with evidence of viral drug resistance-associated substitutions at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with evidence of viral drug resistance-associated substitutions at Week 48
  • Participants with evidence of viral drug resistance-associated substitutions at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with evidence of viral drug resistance-associated substitutions at Week 96
  • Change from baseline in fasting low-density lipoprotein cholesterol and nonhigh- density lipoprotein cholesterol to Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline in fasting low-density lipoprotein cholesterol and non-high- density lipoprotein cholesterol to Week 24
  • Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 48
  • Change from baseline in body weight at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in body weight at Week 48
  • Participants with one or more AEs up to Week 96 [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants with one or more AEs from Day 1 up to Week 96
  • Participants who discontinued study intervention up to Week 96 [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants who discontinued study intervention due to an AE from Day 1 up to Week 96
  • Participants with one or more AEs from Week 48 up to Week 96 [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants with one or more AEs from Week 48 up to Week 96
  • Participants who discontinued study intervention from Week 48 up to Week 96 [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants who discontinued study intervention due to an AE from Week 48 up to Week 96
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017))
Official Title  ICMJE 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
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 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 proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE Drug: DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
Other Name: MK-8591A
Study Arms  ICMJE
  • Experimental: Immediate Switch to DOR/ISL
    Participants receiving continuous antiretroviral therapy (ART) will switch to MK-8591A, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 96 weeks
    Intervention: Drug: DOR/ISL
  • Active Comparator: Baseline Regimen with Delayed Switch to DOR/ISL
    Participants receiving continuous ART for 48 weeks will switch to MK-8591A, a FDC of 100 mg DOR/0.75 mg ISL for 48 weeks
    Intervention: Drug: DOR/ISL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 7, 2021)
672
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2020)
578
Estimated Study Completion Date  ICMJE September 16, 2022
Actual Primary Completion Date September 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Chile,   Colombia,   France,   Italy,   Japan,   New Zealand,   Poland,   Russian Federation,   South Africa,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04223778
Other Study ID Numbers  ICMJE 8591A-017
2019-000586-20 ( EudraCT Number )
MK-8591A-017 ( Other Identifier: Merck )
205165 ( Registry Identifier: JAPIC-CTI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP