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

NCT04493216 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2024-06-26

Study results available
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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

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.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2022-09-05
Completion
2023-05-29
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • France
  • Germany
  • Italy
  • Portugal
  • Russia
  • South Africa
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT04493216 on ClinicalTrials.gov