An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

April 4, 2017 updated by: ViiV Healthcare
This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1202
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1264AAV
        • GSK Investigational Site
      • Buenos Aires, Argentina, C1282AEN
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1000
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Leuven, Belgium, 3000
        • GSK Investigational Site
  • Italy
      • Modena, Italy, 41124
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20127
        • GSK Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85-030
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 129110
        • GSK Investigational Site
      • Moscow, Russian Federation, 105275
        • GSK Investigational Site
      • N.Novgorod, Russian Federation, 603005
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 190103
        • GSK Investigational Site
      • Smolensk, Russian Federation, 214006
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 196645
        • GSK Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9301
        • GSK Investigational Site
      • Dundee, South Africa, 3000
        • GSK Investigational Site
      • Gauteng, South Africa, 2047
        • GSK Investigational Site
      • Port Elizabeth, South Africa, 6070
        • GSK Investigational Site
      • Pretoria, South Africa, 0083
        • GSK Investigational Site
      • Pretoria North, South Africa, 0116
        • GSK Investigational Site
      • Westdene, South Africa, 2092
        • GSK Investigational Site
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • GSK Investigational Site
    • Gauteng
      • Soweto, Gauteng, South Africa, 2013
        • GSK Investigational Site
  • Switzerland
      • Bern, Switzerland, CH-3010
        • GSK Investigational Site
      • Lugano, Switzerland, 6900
        • GSK Investigational Site
      • Zuerich, Switzerland, 8091
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  • Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment.
  • Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria.
  • Subject agrees to the specified study procedures.

Exclusion Criteria:

  • Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial.
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Contra-indications to use of maraviroc as described in the Investigator Brochure.
  • Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 24, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116278

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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