NCT04493216

A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults

A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses \[100, 150 and 200 milligrams {mg}\]), active controlled clinical trial. It aims to investigate the safety, efficacy and dose-response of GSK3640254 compared to dolutegravir (DTG), each given in combination with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) (abacavir/lamivudine \[ABC/3TC\] or emtricitabine/tenofovir alafenamide \[FTC/TAF\]).

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	GSK3640254	GSK3640254 was available as a 25 mg and 100 mg tablets to be administered via oral route.
DRUG	ABC/3TC	ABC/3TC was available as abacavir 600 mg/lamivudine 300 mg tablet to be administered via oral route.
DRUG	FTC/TAF	FTC/TAF was available as emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet to be administered via oral route.
DRUG	Dolutegravir	Dolutegravir was available as a 50 mg tablet to be administered via oral route.
DRUG	Placebo	Placebo matching GSK3640254 was administered in the form of tablets via oral route.

Timeline

• Start date: 2020-11-18
• Primary completion: 2022-09-05
• Completion: 2023-05-29
• First posted: 2020-07-30
• Last updated: 2024-06-26
• Results posted: 2023-11-18

Locations

65 sites across 11 countries: United States, Argentina, Canada, France, Germany, Italy, Portugal, Russia, South Africa, Spain, Switzerland

Regulatory

• FDA-regulated drug study