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Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)

NCT01231555 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-11-17

Study results available
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Summary

This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label efavirenz (EFV) 600 mg once daily. The background ART for all 3 arms will be chosen by the Investigators and will be either abacavir/lamivudine \[ABC/3TC\] or tenofovir/emtricitabine \[TDF/FTC\] fixed dose combination (FDC) tablets. Antiviral activity, safety, PK, and development of viral resistance will be evaluated.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

GSK2248761 100 mg once daily

1x100 mg capsule plus matching placebo

DRUG

GSK2248761 200 mg once daily

2x100 mg capsules

DRUG

Efavirenz 600 mg once daily

1x600mg tablet

Sponsors & Collaborators

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
2010-11-18
Primary Completion
2011-07-04
Completion
2011-07-04

Countries

  • France
  • Germany
  • 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 NCT01231555 on ClinicalTrials.gov