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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)
Overall Recruitment Status: Active, currently enrolling
 
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)
 
Region Sponsors
California - Southern
Merck Sharp & Dohme Corp.
 
Acronym KP IRB No.
12311
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with confirmed HIV Infection .
 
Purpose
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
 
Detailed Description
Participants with (Human Immunodeficiency Virus 1 ribonucleic acid ) HIV-1 RNA = >50 copies/mL at Week 48. Time Frame: Week 48 Percentage of participants with (Human Immunodeficiency Virus 1 ribonucleic acid) HIV-1 RNA = >50 copies/mL at Week 48. Participants with one or more adverse events (AEs) up to Week 48. Time Frame: Up to 48 weeks. Percentage of participants with one or more adverse events (AEs) up to Week 48. Participants who discontinued study intervention due to an AE up to Week 48. Time Frame: Up to 48 weeks. Percentage of participants who discontinued study intervention due to an AE up to Week 48.
 
Gender Age Limit
Male & Female
 
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

 
Keywords and/or Specific Medical Conditions
  • 4'-ethynyl-2-fluoro-2'-deoxyadenosine
  • Lentivirus Infections
  • Anti-HIV Agents
  • Molecular Mechanisms of Pharmacological Action
  • Anti-Infective Agents
  • Nucleic Acid Synthesis Inhibitors
  • Anti-Retroviral Agents
  • Retroviridae Infections
  • Antiviral Agents
  • Reverse Transcriptase Inhibitors
  • Emtricitabine
  • RNA Virus Infections
  • Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Sexually Transmitted Diseases
  • Enzyme Inhibitors
  • Sexually Transmitted Diseases, Viral
  • HIV Infections
  • Tenofovir
  • Immune System Diseases
  • Virus Diseases
  • Immunologic Deficiency Syndromes
  • Infectious Diseases
 
KP Clinical Facility
  • Southern California
 
Clinical Area
  • Infectious Diseases


Principal Investigator:
William Towner Towner, MD
Contact Information:
- Tiffany Castanon
-626-564-5667
-Southern California


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