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Adult Trials: 18+ Years
- Patients at least 16 years old with prior extensive treatment experience with limited further options in need of maraviroc to constitute an effective HIV-1 treatment regimen.
- Have only CCR5-tropic HIV-1 virus
- CD4+ cell count < 200 cells/mm3
- CXCR4- or dual/mixed-tropic HIV-1 virus
- Patients who in the opinion of investigator are unlikely to derive benefit from
maraviroc as a result of severity of illness
- Patients who are pregnant or breast feeding an infant or planning to become pregnant.
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| 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 ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (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 Arms ICMJE | 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| Recruitment Status ICMJE | Withdrawn | |||
| Actual Enrollment ICMJE | 0 | |||
| Original Estimated Enrollment ICMJE | 30 | |||
| Estimated Study Completion Date ICMJE | May 2010 | |||
| Estimated Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00719823 | |||
| Other Study ID Numbers ICMJE | A4001068 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | ViiV Healthcare | |||
| Study Sponsor ICMJE | ViiV Healthcare | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | ViiV Healthcare | |||
| Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||