Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    100
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 11 May 2021

Summary

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve 0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

Description

Part 1 of this study (Day 1 to Day 7) is the double-blind period in which participants receive either ISL, DOR, DOR/ISL, or placebo. Part 2 of this study (Day 8 to Week 97) is the open-label period in which all participants receive DOR/ISL + optimized background therapy (OBT).

Details
Condition HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection, HIV-1 Infection
Treatment DOR/ISL, ISL, ISL, DOR, DOR, Placebo to ISL, Placebo to DOR
Clinical Study IdentifierNCT04233216
SponsorMerck Sharp & Dohme Corp.
Last Modified on11 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Gender: Male or Female
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have any of these conditions: Do you have HIV-1 Infection??
Do you have HIV-1 Infection?
Is HIV-1 positive
Has been receiving the same baseline ART for 3 months prior to signing the Informed Consent Form/Assent Form
Weighs 35 kg
Has at least triple-class resistance (nucleoside reverse transcriptase inhibitor [NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and resistance to at least 1 other class [i.e., resistance to at least 1 drug in each class]) based on resistance testing at the Screening Visit
Has 1 fully active antiretroviral remaining that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or acceptability to participant
If female, is not pregnant or breastfeeding, and is: 1) not a woman of childbearing potential (WOCBP); 2) a WOCBP and uses an acceptable method of contraception/is abstinent; or 3) a WOCBP and has a negative pregnancy test within 24 hours of the first dose of study medication

Exclusion Criteria

Has HIV type 2 (HIV-2) infection
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has hepatitis B virus (HBV) co-infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive) and is not currently being treated for HBV
Has a history or current evidence of any condition, therapy (including active TB co-infection), laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with study participation for the full study duration
Is taking or is anticipated to require any of the prohibited therapies from the Screening Visit and throughout the study treatment period
Is taking DOR as part of his/her current failing antiretroviral regimen
Is taking efavirenz (EFV), etravirine, or nevirapine
Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period
Is female and is expecting to conceive or donate eggs at any time during the study
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