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Dose Ranging, Switch Study of Islatravir (ISL) and MK-8507 Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

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: NCT04564547
Recruitment Status : Active, not recruiting
First Posted : September 25, 2020
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + MK-8507 based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.

Condition or disease Intervention/treatment Phase
HIV-1 Infection Drug: Islatravir Drug: MK-8507 Drug: BIC/FTC/TAF Drug: Placebo to ISL Drug: Placebo to MK-8507 Drug: Placebo to BIC/FTC/TAF Phase 2

Detailed Description:
As of protocol amendment 2 (approved 01-Dec-2021), all participants are unblinded and discontinued from study therapy, and will be switched to non-study antiretroviral therapy. Participants who received ISL + MK-8507 will be followed for ≥6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily
Actual Study Start Date : March 9, 2021
Estimated Primary Completion Date : June 24, 2023
Estimated Study Completion Date : June 24, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group 1: ISL 20 mg + MK-8507 100 mg
Participants receive ISL 20 mg (Parts 1-3) + MK-8507 100 mg once weekly (QW) and placebo to BIC/FTC/TAF once daily (QD) [Part 1].
Drug: Islatravir
ISL capsule taken by mouth.
Other Name: MK-8591

Drug: MK-8507
MK-8507 tablet taken by mouth.

Drug: Placebo to MK-8507
Placebo tablet matched to MK-8507 taken by mouth.

Drug: Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.

Experimental: Group 2: ISL 20 mg + MK-8507 200 mg
Participants receive ISL 20 mg (Parts 1-3) + MK-8507 200 mg QW and placebo to BIC/FTC/TAF QD (Part 1).
Drug: Islatravir
ISL capsule taken by mouth.
Other Name: MK-8591

Drug: MK-8507
MK-8507 tablet taken by mouth.

Drug: Placebo to MK-8507
Placebo tablet matched to MK-8507 taken by mouth.

Drug: Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.

Experimental: Group 3: ISL 20 mg + MK-8507 400 mg
Participants receive ISL 20 mg (Parts 1-3) + MK-8507 400 mg QW and placebo to BIC/FTC/TAF QD (Part 1).
Drug: Islatravir
ISL capsule taken by mouth.
Other Name: MK-8591

Drug: MK-8507
MK-8507 tablet taken by mouth.

Drug: Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF taken by mouth.

Active Comparator: Group 4: BIC/FTC/TAF
Participants receive placebo to ISL + placebo to MK-8507 QW (Part 1) and BIC/FTC/TAF 50 mg/200 mg/25 mg QD (Parts 1 and 2).
Drug: BIC/FTC/TAF
BIC/FTC/TAF tablet taken by mouth.
Other Name: BIKTARVY®

Drug: Placebo to ISL
Placebo capsule matched to ISL taken by mouth.

Drug: Placebo to MK-8507
Placebo tablet matched to MK-8507 taken by mouth.




Primary Outcome Measures :
  1. Percentage of participants with ≥1 adverse event (AE) [ Time Frame: Up to ≥96 weeks ]
    The percentage of participants with AEs will be determined.

  2. Percentage of participants discontinuing study intervention due to AE [ Time Frame: Up to ≥96 weeks ]
    The percentage of participants discontinuing due to AEs will be determined.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
  • Has been virologically suppressed on BIC/FTC/TAF for ≥6 months
  • Has a screening CD4+ T-cell count >200 cells/mm^3 (completed by the central laboratory)
  • Is male or female, at least 18 years of age, at the time of signing the informed consent
  • female participant 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 a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis)

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 active hepatitis C virus (HCV) coinfection (defined as detectable HCV RNA) or hepatitis B virus (HBV) coinfection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive)
  • Has a current (active) diagnosis of acute hepatitis due to any cause
  • 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
  • Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
  • 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 virological resistance to MK-8507 or nucleoside/nucleotide reverse transcriptase inhibitors (NNRTI)
  • Is female and expecting to conceive or donate eggs at any time during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04564547


Locations
Show Show 23 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT04564547    
Other Study ID Numbers: 8591-013
MK-8591-013 ( Other Identifier: Merck Protocol Number )
2020-003071-18 ( EudraCT Number )
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Islatravir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Anti-Retroviral Agents