A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India
Expanded access is no longer available for this treatment.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00992654
First received: October 8, 2009
Last updated: November 15, 2010
Last verified: November 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 8, 2009 | ||||
| Last Updated Date | November 15, 2010 | ||||
| Start Date ICMJE | November 2009 | ||||
| Estimated Primary Completion Date | February 2010 (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 NCT00992654 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 Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India | ||||
| Official Title ICMJE | A Local, Multicentre, Open Label Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India | ||||
| Brief Summary | The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Expanded Access | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Not Provided | ||||
| Condition ICMJE | Human Immunodeficiency Virus (HIV) | ||||
| Intervention ICMJE | Drug: Open Label Treatment Access: Maraviroc
Oral dosing twice daily. The dose will depend on the optimized background therapy.
Other Name: Maraviroc, Celsentri, Selzentry |
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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 | ||||
| Estimated Completion Date | February 2010 | ||||
| Estimated Primary Completion Date | February 2010 (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 | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00992654 | ||||
| Other Study ID Numbers ICMJE | A4001096, A4001050 | ||||
| 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 | November 2010 | ||||
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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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