An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
Expanded access is no longer available for this treatment.
Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01776996
First received: January 24, 2013
Last updated: April 4, 2017
Last verified: April 2017
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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 |
|---|---|
|
Infection, Human Immunodeficiency Virus |
Drug: Continued Access Arm |
| Study Type: |
Expanded Access
What is Expanded Access?
Available for Intermediate-size Population |
| 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:
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 (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
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
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, 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 | |
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | ViiV Healthcare |
More Information
| Responsible Party: | ViiV Healthcare |
| ClinicalTrials.gov Identifier: | NCT01776996 History of Changes |
| Other Study ID Numbers: |
116278 |
| Study First Received: | January 24, 2013 |
| Last Updated: | April 4, 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 |
ClinicalTrials.gov processed this record on May 25, 2017