An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
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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. |
ClinicalTrials.gov Identifier: NCT01776996 |
Recruitment Status
:
No longer available
First Posted
: January 28, 2013
Last Update Posted
: April 6, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Infection, Human Immunodeficiency Virus | Drug: Continued Access Arm |
Study Type : |
Expanded Access
Intermediate-size Population |
Official Title: | An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc |

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Drug: Continued Access Arm

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.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT01776996
Argentina | |
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 | |
Belgium | |
GSK Investigational Site | |
Brussels, Belgium, 1000 | |
GSK Investigational Site | |
Gent, Belgium, 9000 | |
GSK Investigational Site | |
Leuven, Belgium, 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, 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 | |
Switzerland | |
GSK Investigational Site | |
Bern, Switzerland, CH-3010 | |
GSK Investigational Site | |
Lugano, Switzerland, 6900 | |
GSK Investigational Site | |
Zuerich, Switzerland, 8091 |
Study Director: | GSK Clinical Trials | ViiV Healthcare |
Responsible Party: | ViiV Healthcare |
ClinicalTrials.gov 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:
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Slow Virus Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |