MedTrace Logo

Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1

NCT01345630 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 813

Last updated 2016-01-14

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

Conditions

Interventions

DRUG

Maraviroc

Maraviroc tablet 150 mg once daily for 96 weeks.

DRUG

Emtricitabine/tenofovir

Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.

DRUG

darunavir/ritonavir 800/100 mg

darunavir/ritonavir 800/100 mg

DRUG

placebo for emtricitabine/tenofovir

placebo for emtricitabine/tenofovir

DRUG

placebo for maraviroc

placebo for maraviroc

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-08-31
Completion
2014-01-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT01345630 on ClinicalTrials.gov