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The trial is taking place at:
T

The Crofoot Research Center, Inc. | Houston, TX

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A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Active, not recruiting
Phase 3

Conditions

HIV-1 Infection

Treatments

Drug: BIC/FTC/TAF
Drug: DOR/ISL
Drug: Placebo to DOR/ISL
Drug: Placebo to BIC/FTC/TAF

Study type

Interventional

Funder types

Industry

Identifiers

NCT05630755
8591A-052
MK-8591A-052 (Other Identifier)
2022-502079-49-00 (Registry Identifier)
jRCT2051230003 (Registry Identifier)

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) at Week 48; and to evaluate the safety and tolerability of a switch to DOR/ISL compared with continued BIC/FTC/TAF, through Week 48. The primary hypotheses are that (1) DOR/ISL is non-inferior to continued BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority; and (2) DOR/ISL is superior to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48.

Enrollment

514 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL
  • Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
  • Female is not a participant of childbearing potential (POCBP); or if a participant of childbearing potential, not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

Exclusion Criteria:

  • Has HIV-2 infection
  • Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
  • Has active hepatitis B virus (HBV) infection
  • Has chronic hepatitis C virus (HCV) infection with laboratory values consistent with cirrhosis
  • Has a history of malignancy ≤5 years prior to providing documented 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 strong and moderate cytochrome P450 3A (CYP3A ) inducers
  • Has a documented or known virologic resistance to DOR
  • Has taken long-acting HIV therapy at any time (e.g., cabotegravir, lenacapavir)
  • Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period except those currently enrolled in the comparator arm of an ongoing DOR/ISL study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

514 participants in 2 patient groups

DOR/ISL and Placebo to BIC/FTC/TAF
Experimental group
Description:
Participants will receive DOR/ISL 100 mg/0.25 mg and Placebo to BIC/FTC/TAF once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may continue on DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
Treatment:
Drug: Placebo to BIC/FTC/TAF
Drug: DOR/ISL
BIC/FTC/TAF and Placebo to DOR/ISL
Active Comparator group
Description:
Participants will receive BIC/FTC/TAF 50 mg/200 mg/25 mg and Placebo to DOR/ISL once daily (QD) orally from day 1 to week 144. After week 144, eligible participants may switch to DOR/ISL and continue study treatment until week 240 or to when DOR/ISL becomes commercially accessible (whichever comes first).
Treatment:
Drug: Placebo to DOR/ISL
Drug: BIC/FTC/TAF

Trial contacts and locations

49

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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