Maraviroc Compassionate Use

This study has been withdrawn prior to enrollment.
Sponsor:
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

July 18, 2008
November 10, 2010
August 2008
May 2010   (final data collection date for primary outcome measure)
Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two Years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00719823 on ClinicalTrials.gov Archive Site
Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Maraviroc Compassionate Use
Maraviroc Compassionate Use

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.

This study was cancelled prior to enrollment.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Human Immunodeficiency Virus Type 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.
1
Intervention: Drug: Maraviroc
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00719823
A4001068
No
Director, Clinical Trial Disclosure Group, Pfizer Inc.
ViiV Healthcare
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
ViiV Healthcare
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP