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Expanded Access Program for Maraviroc At Multiple Centers

NCT00426660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1047

Last updated 2016-06-29

Study results available
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Summary

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

Conditions

  • HIV Infections

Interventions

DRUG

maraviroc

The nominal dose for maraviroc is 300 mg twice a day (BID). However, the dosage of maraviroc should be adjusted based on optimal background therapy (OBT) patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Costa Rica
  • Dominican Republic
  • France
  • Germany
  • Greece
  • Hong Kong
  • India
  • Ireland
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • Portugal
  • Puerto Rico
  • Romania
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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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 NCT00426660 on ClinicalTrials.gov