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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01776996
Expanded Access Status : No longer available
First Posted : January 28, 2013
Last Update Posted : April 6, 2017
Information provided by (Responsible Party):
ViiV Healthcare

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.

Condition or disease Intervention/treatment
Infection, Human Immunodeficiency Virus Drug: Continued Access Arm

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc

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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01776996

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GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Buenos Aires, Argentina, 1202
GSK Investigational Site
Buenos Aires, Argentina, C1264AAV
GSK Investigational Site
Buenos Aires, Argentina, C1282AEN
GSK Investigational Site
Brussels, Belgium, 1000
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Milano, Lombardia, Italy, 20127
GSK Investigational Site
Modena, Italy, 41124
GSK Investigational Site
Bydgoszcz, Poland, 85-030
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 105275
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
Port Elizabeth, Eastern Cape, South Africa, 6001
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 North, South Africa, 0116
GSK Investigational Site
Pretoria, South Africa, 0083
GSK Investigational Site
Westdene, South Africa, 2092
GSK Investigational Site
Bern, Switzerland, CH-3010
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Zuerich, Switzerland, 8091
Sponsors and Collaborators
ViiV Healthcare
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare Identifier: NCT01776996     History of Changes
Other Study ID Numbers: 116278
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Keywords provided by ViiV Healthcare:
Expanded access, HIV, maraviroc
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
HIV Fusion Inhibitors
Viral Fusion Protein Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
CCR5 Receptor Antagonists