MedTrace Logo

Safety, Efficacy and Dose-response Study of BMS-986001 in Subjects With HIV-1 Infection Who Are Treatment-naive

NCT01489046 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2016-04-15

No results posted yet for this study

Summary

The purpose of this study is to identify at least one dose of BMS-986001 which is safe, well tolerated, and efficacious when combined with Efavirenz (EFV) + Lamivudine (3TC) for treatment-naive Human Immunodeficiency Virus 1 (HIV-1) infected subjects

Conditions

  • HIV-1 Infection

Interventions

DRUG

BMS-986001

Capsules, Oral, 100 mg, Once daily, At least 48 weeks

DRUG

BMS-986001

Capsules, Oral, 200 mg, Once daily, At least 48 weeks

DRUG

BMS-986001

Capsules, Oral, 400 mg, Once daily, At least 48 weeks

DRUG

Placebo matching with BMS-986001

Capsules, Oral, 0 mg, Once daily, At least 48 weeks

DRUG

Efavirenz

Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase

DRUG

Lamivudine

Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

DRUG

Tenofovir

Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-03-31
Completion
2014-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • Colombia
  • France
  • Hungary
  • Mexico
  • Peru
  • South Africa
  • Spain
  • Thailand

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 NCT01489046 on ClinicalTrials.gov