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This study has been withdrawn prior to enrollment.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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Human Immunodeficiency Virus Type 1 |
Drug: Maraviroc |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Maraviroc Compassionate Use |
Resource links provided by NLM:
Further study details as provided by ViiV Healthcare:
Primary Outcome Measures:
- Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
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.
|
Detailed Description:
This study was cancelled prior to enrollment.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719823
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719823
Sponsors and Collaborators
ViiV Healthcare
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer Inc. |
| ClinicalTrials.gov Identifier: | NCT00719823 History of Changes |
| Other Study ID Numbers: | A4001068 |
| Study First Received: | July 18, 2008 |
| Last Updated: | November 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ViiV Healthcare:
|
Maraviroc Compassionate Use |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections |
Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015