NCT01776996

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
7 countries

28 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

First QC Date

January 24, 2013

Last Update Submit

April 4, 2017

Conditions

Infection, Human Immunodeficiency Virus

Keywords

Expanded access, HIV, maraviroc

Interventions

Continued Access ArmDRUG

All subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day.

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 agrees to the specified study procedures.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

GSK Investigational Site

Buenos Aires, Buenos Aires, 1202, Argentina

Location

GSK Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

Location

GSK Investigational Site

Buenos Aires, C1264AAV, Argentina

Location

GSK Investigational Site

Buenos Aires, C1282AEN, Argentina

Location

GSK Investigational Site

Brussels, 1000, Belgium

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Milan, Lombardy, 20127, Italy

Location

GSK Investigational Site

Modena, 41124, Italy

Location

GSK Investigational Site

Bydgoszcz, 85-030, Poland

Location

GSK Investigational Site

Moscow, 105275, Russia

Location

GSK Investigational Site

Moscow, 129110, Russia

Location

GSK Investigational Site

N.Novgorod, 603005, Russia

Location

GSK Investigational Site

Saint Petersburg, 190103, Russia

Location

GSK Investigational Site

Saint Petersburg, 196645, Russia

Location

GSK Investigational Site

Smolensk, 214006, Russia

Location

GSK Investigational Site

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

GSK Investigational Site

Gauteng, Gauteng, 2047, South Africa

Location

GSK Investigational Site

Soweto, Gauteng, 2013, South Africa

Location

GSK Investigational Site

Bloemfontein, 9301, South Africa

Location

GSK Investigational Site

Dundee, 3000, South Africa

Location

GSK Investigational Site

Port Elizabeth, 6070, South Africa

Location

GSK Investigational Site

Pretoria, 0083, South Africa

Location

GSK Investigational Site

Pretoria North, 0116, South Africa

Location

GSK Investigational Site

Westdene, 2092, South Africa

Location

GSK Investigational Site

Bern, CH-3010, Switzerland

Location

GSK Investigational Site

Lugano, 6900, Switzerland

Location

GSK Investigational Site

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2013

First Posted

January 28, 2013

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

BE(3)IT(2)RU(6)ZA(9)CH(3)PL(1)AR(4)