MedTrace Logo

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

NCT04900038 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-12-14

Study results available
· View outcomes & findings →

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.

Conditions

  • HIV Infections

Interventions

DRUG

GSK3640254

GSK3640254 was available as 25 mg or 100 mg tablets administered orally.

DRUG

Dolutegravir

DTG was available as 50 mg tablets administered orally.

DRUG

Lamivudine capsules

3TC was available as 300 mg capsules administered orally as a blinded treatment.

DRUG

Lamivudine tablets

3TC was available as 300 mg tablets administered orally as an unblinded treatment.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-18
Primary Completion
2022-11-22
Completion
2023-05-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Germany
  • Italy
  • Portugal
  • Puerto Rico
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04900038 on ClinicalTrials.gov