drugset / Trial / NCT04900038

A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults

NCT04900038

Phase 2 Terminated 85 enrolled ViiV Healthcare Syneos Health · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study was to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1. The participants were randomized to one of the three doses of blinded GSK3640254 (100, 150, or 200 milligrams \[mgs\]) or a reference arm of blinded 3TC-each in combination with open label DTG.

Timeline

Start
2021-08-18
Primary completion
2022-11-22
Completion
2023-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Dolutegravir Other / unclassified 50 mg Oral
Subject FIPRAVIRIMAT Small molecule 100 mg Oral
Subject FIPRAVIRIMAT Small molecule 150 mg Oral
Subject FIPRAVIRIMAT Small molecule 200 mg Oral
Comparator Lamivudine Other / unclassified 300 mg Oral