This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Delstrigo
  • /
  • Safety and Efficacy of a Switch to MK-1439A in Hum...
Clinical trial

Safety and Efficacy of a Switch to MK-1439A in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (DRIVE-SHIF

Read time: 3 mins
Last updated:8th Jun 2015
Identifier: NCT02397096

Brief Summary:
The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-1439A will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study results will be based on the first 48 weeks of this ongoing study.

Detailed Description:
Two optional study extensions are planned. Study Extension 1 will evaluate safety of the switch to MK-1439A for an additional 2 years beyond the Base Study. Study Extension 2 will evaluate safety of the switch to MK-1439A until MK-1439A becomes locally available, or 2 years beyond Study Extension 1, whichever comes first.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 673 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Actual Study Start Date: June 9, 2015
Actual Primary Completion Date: February 22, 2018
Estimated Study Completion Date: November 2, 2021

- Experimental:
Immediate Switch to MK-1439A
- Active Comparator: Delayed Switch to MK-1439A

Category Value
Date last updated at source 2019-04-03
Study type(s) Interventional
Expected enrolment 673
Study start date 2015-06-09
Estimated primary completion date 2018-02-22

View full details