A Compassionate Access Protocol For Those Patients Who Have Completed A4001029
Expanded access is no longer available for this treatment.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00801515
First received: December 2, 2008
Last updated: July 21, 2011
Last verified: July 2011
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 2, 2008 | ||||
| Last Updated Date | July 21, 2011 | ||||
| Start Date ICMJE | August 2009 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00801515 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Compassionate Access Protocol For Those Patients Who Have Completed A4001029 | ||||
| Official Title ICMJE | A Compassionate Access Protocol For Those Patients Who Have Completed A4001029 | ||||
| Brief Summary | This is a compassionate study to provide continued access to maraviroc for only those subjects completing study A4001029 who are showing clinical benefit. Assessments of safety and tolerability of maraviroc when added to OBT will be continued. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Expanded Access | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Not Provided | ||||
| Condition ICMJE | HIV | ||||
| Intervention ICMJE | Drug: Maraviroc
150 mg twice per day
Other Name: Celsentri |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | No longer available | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00801515 | ||||
| Other Study ID Numbers ICMJE | A4001090 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
| Study Sponsor ICMJE | ViiV Healthcare | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | ViiV Healthcare | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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