An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc
This study is currently recruiting participants.
Verified January 2013 by ViiV Healthcare
Sponsor:
ViiV Healthcare
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT01776996
First received: January 24, 2013
Last updated: February 14, 2013
Last verified: January 2013
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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 | 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Maraviroc
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776996
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Poland | |
| GSK Investigational Site | Not yet recruiting |
| Bydgoszcz, Poland, 85-030 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Krakow, Poland, 31-501 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Szczecin, Poland, 71-455 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Russian Federation | |
| GSK Investigational Site | Not yet recruiting |
| Krasnojarsk, Russian Federation, 660049 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Moscow, Russian Federation, 111123 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Moscow, Russian Federation, 129110 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| N.Novgorod, Russian Federation, 603005 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Saint-Petersburg, Russian Federation, 190103 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Smolensk, Russian Federation, 214006 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| St. Petersburg, Russian Federation, 196645 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| South Africa | |
| GSK Investigational Site | Recruiting |
| Dundee, South Africa, 3000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
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: | February 14, 2013 |
| 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 May 22, 2013