Maraviroc Compassionate Use
This study has been withdrawn prior to enrollment.
Sponsor:
ViiV Healthcare
Collaborator:
Pfizer
Information provided by:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00719823
First received: July 18, 2008
Last updated: November 10, 2010
Last verified: November 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 18, 2008 | ||||
| Last Updated Date | November 10, 2010 | ||||
| Start Date ICMJE | August 2008 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00719823 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Maraviroc Compassionate Use | ||||
| Official Title ICMJE | Maraviroc Compassionate Use | ||||
| Brief Summary | The objective of this study is to provide Maraviroc on a compassionate use basis to antiretroviral treatment experienced patients infected with CCR5-tropic HIV-1 with urgent unmet medical needs and who, in the opinion of the physician, require Maraviroc to form a viable regimen. |
||||
| Detailed Description | This study was cancelled prior to enrollment. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
||||
| Condition ICMJE | Human Immunodeficiency Virus Type 1 | ||||
| Intervention ICMJE | Drug: Maraviroc
Maraviroc 150mg, 300 mg or 600 mg twice daily administered orally with or without food in combination with other antiretroviral agents. The recommended dose of Maraviroc differs based on concomitant medications due to drug interactions as outlined in the Prescribing Information. |
||||
| Study Arm (s) | 1
Intervention: Drug: Maraviroc |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 16 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 | NCT00719823 | ||||
| Other Study ID Numbers ICMJE | A4001068 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc. | ||||
| Study Sponsor ICMJE | ViiV Healthcare | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | ViiV Healthcare | ||||
| Verification Date | November 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||