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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01776996
First received: January 24, 2013
Last updated: July 10, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus
Drug: Continued Access Arm
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • Provide continued access to Maraviroc to subjects who have completed previous studies of Maraviroc and continue to receive clinical benefit. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: May 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Continued Access Arm
    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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776996

Locations
Argentina
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Buenos Aires, Argentina, C1282AEN
GSK Investigational Site
Buenos Aires, Argentina, C1264AAV
GSK Investigational Site
Buenos Aires, Argentina, 1202
Belgium
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, B-3000
Italy
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Modena, Italy, 41124
Poland
GSK Investigational Site
Bydgoszcz, Poland, 85-030
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 111123
GSK Investigational Site
Moscow, Russian Federation, 129110
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
South Africa
GSK Investigational Site
Soweto, Gauteng, South Africa, 2013
GSK Investigational Site
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
Switzerland
GSK Investigational Site
Bern, Switzerland, CH-3010
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Zuerich, Switzerland, 8091
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

No publications provided

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT01776996     History of Changes
Other Study ID Numbers: 116278
Study First Received: January 24, 2013
Last Updated: July 10, 2014
Health Authority: Argentina: Ciudad Autonma de Buenos Aires

Keywords provided by ViiV Healthcare:
Expanded access, HIV, maraviroc

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014